{"id":"lifitegrast","rwe":[],"_fda":{"id":"2770cd53-f66c-2097-e063-6394a90a874b","set_id":"1a914080-a3c0-44be-b601-0ae3160e77eb","openfda":{"nui":["N0000192701","N0000192700"],"unii":["038E5L962W"],"route":["OPHTHALMIC"],"rxcui":["1801835","1801840"],"spl_id":["2770cd53-f66c-2097-e063-6394a90a874b"],"brand_name":["Xiidra"],"spl_set_id":["1a914080-a3c0-44be-b601-0ae3160e77eb"],"package_ndc":["24208-911-05","24208-911-12","24208-911-95","24208-911-94"],"product_ndc":["24208-911"],"generic_name":["LIFITEGRAST"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["LIFITEGRAST"],"pharm_class_epc":["Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]"],"pharm_class_moa":["Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]"],"manufacturer_name":["Bausch & Lomb Incorporated"],"application_number":["NDA208073"],"is_original_packager":[true]},"version":"5","pregnancy":["8.1 Pregnancy Risk Summary There are no available data on Xiidra use in pregnant women to inform any drug-associated risks. Intravenous (IV) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level). Since human systemic exposure to lifitegrast following ocular administration of Xiidra at the RHOD is low, the applicability of animal findings to the risk of Xiidra use in humans during pregnancy is unclear [see Clinical Pharmacology (12.3) ] Data Animal Data Lifitegrast administered daily by IV injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the RHOD of Xiidra, based on AUC. No teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the RHOD, based on AUC). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the RHOD, based on AUC), when administered by IV injection daily from gestation days 7 through 19. A fetal no observed adverse effect level (NOAEL) was not identified in the rabbit."],"description":["11 DESCRIPTION The chemical name for lifitegrast is (S)-2-(2-(benzofuran-6-carbonyl)-5,7-dichloro-1,2,3,4-tetrahydroisoquinoline-6-carboxamido)-3-(3-(methylsulfonyl)phenyl)propanoic acid. The molecular formula of lifitegrast is C 29 H 24 Cl 2 N 2 O 7 S and its molecular weight is 615.5 g/mol. The structural formula of lifitegrast is: *Chiral center Lifitegrast is a white to off-white powder, which is soluble in water. Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist supplied as a sterile, clear, colorless to slightly brownish-yellow colored, isotonic solution of lifitegrast with a pH of 7.0-8.0, and an osmolality range of 200-330 mOsmol/kg. Xiidra contains Active: lifitegrast 50 mg/mL; Inactives: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid (to adjust pH). chem"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Xiidra (lifitegrast ophthalmic solution) 5% (50 mg/mL) is supplied in a foil pouch containing 5 low-density polyethylene 0.2 mL single-use containers. Carton of 60 single-use containers NDC 24208-911-12 Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use containers in the original foil pouch."],"geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients."],"pediatric_use":["8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 17 years have not been established."],"effective_time":"20241121","clinical_studies":["14 CLINICAL STUDIES The safety and efficacy of lifitegrast for the treatment of DED were assessed in a total of 1181 patients (1067 of which received lifitegrast 5%) in four 12‑week, randomized, multi‑center, double‑masked, vehicle‑controlled studies. Patients were randomized to Xiidra or vehicle (placebo) in a 1:1 ratio and dosed twice a day. Use of artificial tears was not allowed during the studies. The mean age was 59 years (range, 19-97 years). The majority of patients were female (76%). Enrollment criteria included minimal signs (i.e., Corneal Fluorescein Staining and non‑anesthetized Schirmer Tear Test) and symptoms (i.e., Eye Dryness Score (EDS) and Ocular Discomfort Score) severity scores at baseline. Effects on Symptoms of Dry Eye Disease Eye dryness score was rated by patients using a visual analogue scale (0 = no discomfort, 100 = maximal discomfort) at each study visit. The average baseline EDS was between 40 and 70. A larger reduction in EDS favoring Xiidra was observed in all studies at Day 42 and Day 84 (see Figure 1). Figure 1: Mean Change (SD) From Baseline and Treatment Difference (Xiidra – Vehicle) in Eye Dryness Score in 12-Week Studies in Patients With Dry Eye Disease [ 1 ] Based on analysis of covariance (ANCOVA) model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one Xiidra-treated subject who did not have a baseline value was excluded from analysis. Effects on Signs of Dry Eye Disease Inferior fluorescein corneal staining score (ICSS) (0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and countable lesions, 3 = lesions too numerous to count but not coalescent, 4 = coalescent) was recorded at each study visit. The average baseline ICSS was approximately 1.8 in Studies 1 and 2, and 2.4 in Studies 3 and 4. At Day 84, a larger reduction in ICSS favoring Xiidra was observed in three of the four studies (see Figure 2). Figure 2: Mean Change (SD) From Baseline and Treatment Difference (Xiidra – Vehicle) in Inferior Corneal Staining Score in 12-Week Studies in Patients With Dry Eye Disease [ 1 ] Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 2, one vehicle-treated subject who did not have a study eye designated was excluded from analysis. Figure 1 Figure 2"],"pharmacokinetics":["12.3 Pharmacokinetics In a subset of DED patients (n = 47) enrolled in a Phase 3 trial, the pre-dose (trough) plasma concentrations of lifitegrast were measured after 180 and 360 days of topical ocular dosing (one drop twice daily) with Xiidra (lifitegrast ophthalmic solution) 5%. A total of nine of the 47 patients (19%) had plasma lifitegrast trough concentrations above 0.5 ng/mL (the lower limit of assay quantitation). Trough plasma concentrations that could be quantitated ranged from 0.55 ng/mL to 3.74 ng/mL."],"adverse_reactions":["6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] The most common adverse reactions (incidence 5%-25%) following the use of Xiidra were instillation-site irritation, dysgeusia, and decreased visual acuity ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In five clinical trials of DED conducted with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received lifitegrast 5%). The majority of patients (84%) had less than or equal to 3 months of treatment exposure. One hundred-seventy patients were exposed to lifitegrast for approximately 12 months. The majority of the treated patients were female (77%). The most common adverse reactions reported in 5%-25% of patients were instillation-site irritation, dysgeusia, and reduced visual acuity. Other adverse reactions reported in 1%-5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus, and sinusitis. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Xiidra. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Rare serious cases of hypersensitivity, including anaphylactic reaction, bronchospasm, respiratory distress, pharyngeal edema, swollen tongue, urticaria, allergic conjunctivitis, dyspnea, angioedema, and allergic dermatitis have been reported. Eye swelling and rash have also been reported [see Contraindications (4) ]"],"contraindications":["4 CONTRAINDICATIONS Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see Adverse Reactions (6.2) ]. Hypersensitivity. ( 4 )"],"mechanism_of_action":["12.1 Mechanism of Action Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule‑1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T‑cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule‑1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T‑cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known. 12.3 Pharmacokinetics In a subset of DED patients (n = 47) enrolled in a Phase 3 trial, the pre-dose (trough) plasma concentrations of lifitegrast were measured after 180 and 360 days of topical ocular dosing (one drop twice daily) with Xiidra (lifitegrast ophthalmic solution) 5%. A total of nine of the 47 patients (19%) had plasma lifitegrast trough concentrations above 0.5 ng/mL (the lower limit of assay quantitation). Trough plasma concentrations that could be quantitated ranged from 0.55 ng/mL to 3.74 ng/mL."],"indications_and_usage":["1 INDICATIONS AND USAGE Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). ( 1 )"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies have not been conducted to determine the carcinogenic potential of lifitegrast. Mutagenesis Lifitegrast was not mutagenic in the in vitro Ames assay. Lifitegrast was not clastogenic in the in vivo mouse micronucleus assay. In an in vitro chromosomal aberration assay using mammalian cells (Chinese hamster ovary cells), lifitegrast was positive at the highest concentration tested, without metabolic activation. Impairment of Fertility Lifitegrast administered at IV doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at the RHOD of lifitegrast ophthalmic solution, 5%) had no effect on fertility and reproductive performance in male and female-treated rats."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA‑approved patient labeling (Patient Information and Instructions for Use). Handling the Single-use Container Advise patients not to touch the tip of the single-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution. Use With Contact Lenses Advise patients that contact lenses should be removed prior to administration of Xiidra and can be reinserted 15 minutes after administration [see Dosage and Administration ( 2 ) ]. Administration Advise patients that the solution from one single-use container is to be used immediately after opening. It can be used to dose both eyes. The single-use container, including any remaining contents should be discarded immediately after administration [see Dosage and Administration (2) ]. Storage Information Instruct patients to store single-use containers in the original foil pouch until ready to use [see How Supplied/Storage and Handling (16) ]. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Patented. See https://patents.bausch.com for US patent information. Xiidra is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2023 Bausch & Lomb Incorporated or its affiliates 9800800 PATIENT INFORMATION XIIDRA ® (ZYE-druh) (lifitegrast ophthalmic solution) 5% for topical ophthalmic use What is Xiidra? Xiidra is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease (DED). It is not known if Xiidra is safe and effective in children under 17 years of age. Do not use Xiidra: If you are allergic to lifitegrast or any of the other ingredients in Xiidra, see “What are the ingredients in Xiidra?” Before you use Xiidra, tell your doctor if you: are using any other eye drops wear contact lenses are pregnant or plan to become pregnant. It is not known if Xiidra will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Xiidra passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Xiidra. How should I use Xiidra? See the complete Instructions for Use at the end of this Patient Information leaflet for detailed instructions about the right way to use Xiidra. Use Xiidra as your doctor tells you. Use one drop of Xiidra in each eye, two times each day, about 12 hours apart. Use Xiidra right away after opening. Throw away the single‑use container and any unused solution after you have applied the dose to both eyes. Do not save any unused Xiidra for later. What are the possible side effects of Xiidra? The most common side effects of Xiidra include eye irritation, discomfort, or blurred vision when the drops are applied to the eyes, and an unusual taste sensation (dysgeusia). Seek medical care immediately if you get any symptoms of wheezing, difficulty breathing, or swollen tongue. These are not all the possible side effects of Xiidra. Tell your doctor if you have any side effects that bother you. You may report side effects to FDA at 1‑800‑FDA‑1088. How should I store Xiidra? Store Xiidra at room temperature between 68°F to 77°F (20°C to 25°C). Store Xiidra in the original foil pouch to protect it from light. Do not open the Xiidra foil pouch until you are ready to use the eye drops. Return unused single‑use containers to their original foil pouch to protect from excessive light exposure. Keep Xiidra and all medicines out of the reach of children. General information about the safe and effective use of Xiidra. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about Xiidra that is written for health professionals. Do not use Xiidra for a condition for which it was not prescribed. Do not give Xiidra to other people, even if they have the same symptoms you have. It may harm them. What are the ingredients in Xiidra? Active ingredient: lifitegrast Inactive ingredients: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid (to adjust pH). Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USA Patented. See https://patents.bausch.com for US patent information. Xiidra is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2023 Bausch & Lomb Incorporated or its affiliates For more information, go to www.Xiidra.com or call 1-800-553-5340. This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: December 2023 9800800"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container. Discard the single‑use container immediately after using in each eye. Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration. One drop twice daily in each eye (approximately 12 hours apart). ( 2 )"],"spl_product_data_elements":["Xiidra Lifitegrast SODIUM CHLORIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM THIOSULFATE SODIUM HYDROXIDE HYDROCHLORIC ACID WATER LIFITEGRAST LIFITEGRAST"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing lifitegrast 50 mg/mL (5%). Ophthalmic solution containing lifitegrast 50 mg/mL (5%). ( 3 )"],"spl_patient_package_insert":["Instructions for Use INSTRUCTIONS FOR USE XIIDRA ® [ZYE-druh] (lifitegrast ophthalmic solution) 5% for topical ophthalmic use Read this Instructions for Use before you start using Xiidra and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment. Important Information You Need to Know Before Using Xiidra: Xiidra is for use in the eye. Wash your hands before each use to make sure you do not infect your eyes while using Xiidra. If you wear contact lenses, remove them before using Xiidra. Xiidra single‑use containers are packaged in a foil pouch. Do not remove from the foil pouch until you are ready to use Xiidra. Do not let the tip of the Xiidra single-use container touch your eye or any other surfaces. Use one drop of Xiidra in each eye two times each day (one drop in the morning and one drop in the evening, approximately 12 hours apart). Each single‑use container of Xiidra will give you enough medicine to treat both of your eyes, one time. There is some extra Xiidra in each single‑use container in case you miss getting a drop into your eye. After you have applied the drops, throw away the single‑use container and any unused Xiidra. Do not save any unused Xiidra. Follow Steps 1 to 9 each time you use Xiidra. Step 1. Take a foil pouch out of the Xiidra box. Open the pouch and remove the strip of single‑use containers (see Figure A ). Pull off one single‑use container from the strip (see Figure B ). Figure A Figure B Step 2. Put the remaining strip of single‑use containers back in the pouch (see Figure C ). Figure C Fold the edge to close the pouch (see Figure D ). Figure D Step 3. Hold the Xiidra container upright (see Figure E ). Tap the top of the container until all of the solution is in the bottom part of the container (see Figure F ). Figure E Figure F Step 4. Open the Xiidra single‑use container by twisting off the tab. Make sure that the tip of the single‑use container does not touch anything, to avoid contamination (see Figure G ). Figure G Step 5. Tilt your head backwards. If you are not able to tilt your head, lie down. Step 6. Gently pull your lower eyelid downwards and look up. Step 7. Place the tip of the Xiidra single‑use container close to your eye, but be careful not to touch your eye with it. Step 8. Gently squeeze the single‑use container and let one drop of Xiidra fall into the space between your lower eyelid and your eye. If a drop misses your eye, try again ( see Figure H ). Figure H Step 9. Repeat Steps 5 to 8 for your other eye. There is enough Xiidra in one single‑use container for both eyes. Once you have applied a drop to both eyes, throw away the opened single‑use container with any remaining solution. If you use contact lenses, wait for at least 15 minutes before placing them back in your eyes. Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USA Patented. See https://patents.bausch.com for US patent information. Xiidra is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2023 Bausch & Lomb Incorporated or its affiliates This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: December 2023 9800800 TAKE FOIL PULL SINGLE VIAL PUT REMAINDER FOLD EDGE HOLD TAP TOP OPEN EYE"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on Xiidra use in pregnant women to inform any drug-associated risks. Intravenous (IV) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level). Since human systemic exposure to lifitegrast following ocular administration of Xiidra at the RHOD is low, the applicability of animal findings to the risk of Xiidra use in humans during pregnancy is unclear [see Clinical Pharmacology (12.3) ] Data Animal Data Lifitegrast administered daily by IV injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the RHOD of Xiidra, based on AUC. No teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the RHOD, based on AUC). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the RHOD, based on AUC), when administered by IV injection daily from gestation days 7 through 19. A fetal no observed adverse effect level (NOAEL) was not identified in the rabbit. 8.2 Lactation Risk Summary There are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lifitegrast from ocular administration is low [see Clinical Pharmacology ( 12.3 )] . The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra. 8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 17 years have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients."],"information_for_patients_table":["
PATIENT INFORMATIONXIIDRA ®(ZYE-druh) (lifitegrast ophthalmic solution) 5%for topical ophthalmic use
What is Xiidra?Xiidra is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease (DED). It is not known if Xiidra is safe and effective in children under 17 years of age.
Do not use Xiidra:If you are allergic to lifitegrast or any of the other ingredients in Xiidra, see “What are the ingredients in Xiidra?”
Before you use Xiidra, tell your doctor if you:are using any other eye dropswear contact lensesare pregnant or plan to become pregnant. It is not known if Xiidra will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if Xiidra passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Xiidra.
How should I use Xiidra?See the complete Instructions for Use at the end of this Patient Information leaflet for detailed instructions about the right way to use Xiidra.Use Xiidra as your doctor tells you.Use one drop of Xiidra in each eye, two times each day, about 12 hours apart.Use Xiidra right away after opening. Throw away the single‑use container and any unused solution after you have applied the dose to both eyes. Do not save any unused Xiidra for later.
What are the possible side effects of Xiidra?The most common side effects of Xiidra include eye irritation, discomfort, or blurred vision when the drops are applied to the eyes, and an unusual taste sensation (dysgeusia).Seek medical care immediately if you get any symptoms of wheezing, difficulty breathing, or swollen tongue.These are not all the possible side effects of Xiidra.Tell your doctor if you have any side effects that bother you. You may report side effects to FDA at 1‑800‑FDA‑1088.
How should I store Xiidra?Store Xiidra at room temperature between 68°F to 77°F (20°C to 25°C).Store Xiidra in the original foil pouch to protect it from light.Do not open the Xiidra foil pouch until you are ready to use the eye drops.Return unused single‑use containers to their original foil pouch to protect from excessive light exposure.Keep Xiidra and all medicines out of the reach of children.
General information about the safe and effective use of Xiidra.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or doctor for information about Xiidra that is written for health professionals. Do not use Xiidra for a condition for which it was not prescribed. Do not give Xiidra to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in Xiidra?Active ingredient: lifitegrastInactive ingredients: sodium chloride, sodium phosphate dibasic anhydrous, sodium thiosulfate pentahydrate, and water for injection. Sodium hydroxide and/or hydrochloric acid (to adjust pH).
Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USAPatented. See https://patents.bausch.comfor US patent information. Xiidra is a trademark of Bausch & Lomb Incorporated or its affiliates.© 2023 Bausch & Lomb Incorporated or its affiliatesFor more information, go to www.Xiidra.com or call 1-800-553-5340.
"],"spl_patient_package_insert_table":["
INSTRUCTIONS FOR USEXIIDRA ®[ZYE-druh] (lifitegrast ophthalmic solution) 5%for topical ophthalmic use
Read this Instructions for Use before you start using Xiidra and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or your treatment.
Important Information You Need to Know Before Using Xiidra:Xiidra is for use in the eye.Wash your hands before each use to make sure you do not infect your eyes while using Xiidra.If you wear contact lenses, remove them before using Xiidra.Xiidra single‑use containers are packaged in a foil pouch. Do not remove from the foil pouch until you are ready to use Xiidra.Do not let the tip of the Xiidra single-use container touch your eye or any other surfaces.Use one drop of Xiidra in each eye two times each day (one drop in the morning and one drop in the evening, approximately 12 hours apart). Each single‑use container of Xiidra will give you enough medicine to treat both of your eyes, one time. There is some extra Xiidra in each single‑use container in case you miss getting a drop into your eye. After you have applied the drops, throw away the single‑use container and any unused Xiidra. Do not save any unused Xiidra.
Follow Steps 1 to 9 each time you use Xiidra.
Step 1.Take a foil pouch out of the Xiidra box. Open the pouch and remove the strip of single‑use containers (see Figure A). Pull off one single‑use container from the strip (see Figure B). Figure AFigure B
","
Step 2.Put the remaining strip of single‑use containers back in the pouch (see Figure C). Figure C
Fold the edge to close the pouch (see Figure D). Figure D
Step 3.Hold the Xiidra container upright (see Figure E). Tap the top of the container until all of the solution is in the bottom part of the container (see Figure F). Figure EFigure F
","
Step 4.Open the Xiidra single‑use container by twisting off the tab. Make sure that the tip of the single‑use container does not touch anything, to avoid contamination (see Figure G). Figure G
Step 5.Tilt your head backwards. If you are not able to tilt your head, lie down.
Step 6.Gently pull your lower eyelid downwards and look up. Step 7.Place the tip of the Xiidra single‑use container close to your eye, but be careful not to touch your eye with it. Step 8.Gently squeeze the single‑use container and let one drop of Xiidra fall into the space between your lower eyelid and your eye. If a drop misses your eye, try again ( see Figure H). Figure H
Step 9. Repeat Steps 5 to 8for your other eye. There is enough Xiidra in one single‑use container for both eyes. Once you have applied a drop to both eyes, throw away the opened single‑use container with any remaining solution.If you use contact lenses, wait for at least 15 minutes before placing them back in your eyes.
Distributed by: Bausch & Lomb Americas Inc., Bridgewater, NJ 08807 USAPatented. See https://patents.bausch.comfor US patent information. Xiidra is a trademark of Bausch & Lomb Incorporated or its affiliates.© 2023 Bausch & Lomb Incorporated or its affiliates
"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-911-12 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each) XIIDRA ®(lifitegrast ophthalmic solution) 5%For Topical Application to the Eye BAUSCH +LOMB 9810300 RPSC0498 carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Animal studies have not been conducted to determine the carcinogenic potential of lifitegrast. Mutagenesis Lifitegrast was not mutagenic in the in vitro Ames assay. Lifitegrast was not clastogenic in the in vivo mouse micronucleus assay. In an in vitro chromosomal aberration assay using mammalian cells (Chinese hamster ovary cells), lifitegrast was positive at the highest concentration tested, without metabolic activation. Impairment of Fertility Lifitegrast administered at IV doses of up to 30 mg/kg/day (5400-fold the human plasma exposure at the RHOD of lifitegrast ophthalmic solution, 5%) had no effect on fertility and reproductive performance in male and female-treated rats."]},"tags":[{"label":"Lymphocyte Function-Associated Antigen-1 Antagonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Intercellular adhesion molecule 1","category":"target"},{"label":"ICAM1","category":"gene"},{"label":"ITGAL","category":"gene"},{"label":"ITGB2","category":"gene"},{"label":"S01XA25","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Solution/ Drops","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"LOE Approaching","category":"status"},{"label":"Tear film insufficiency","category":"indication"},{"label":"Bausch And Lomb Inc","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Ophthalmic Solutions","category":"pharmacology"},{"label":"Pharmaceutical Solutions","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"2649 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"2566 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1536 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"1386 reports"},{"date":"","signal":"INSTILLATION SITE PAIN","source":"FDA FAERS","actionTaken":"1281 reports"},{"date":"","signal":"DRY EYE","source":"FDA FAERS","actionTaken":"1131 reports"},{"date":"","signal":"DYSGEUSIA","source":"FDA FAERS","actionTaken":"1088 reports"},{"date":"","signal":"INSTILLATION SITE REACTION","source":"FDA FAERS","actionTaken":"1019 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"663 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"602 reports"}],"commonSideEffects":[{"effect":"instillation-site irritation","drugRate":"5-25%","severity":"common","_validated":true},{"effect":"dysgeusia","drugRate":"5-25%","severity":"common","_validated":true},{"effect":"decreased visual acuity","drugRate":"5-25%","severity":"common","_validated":true},{"effect":"blurred vision","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"conjunctival hyperemia","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"eye irritation","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"headache","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"increased lacrimation","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"eye discharge","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"eye discomfort","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"eye pruritus","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"sinusitis","drugRate":"1-5%","severity":"mild","_validated":true},{"effect":"hypersensitivity","drugRate":"reported","severity":"unknown"},{"effect":"anaphylactic reaction","drugRate":"reported","severity":"unknown"},{"effect":"bronchospasm","drugRate":"reported","severity":"unknown"},{"effect":"respiratory distress","drugRate":"reported","severity":"unknown"},{"effect":"pharyngeal edema","drugRate":"reported","severity":"unknown"},{"effect":"swollen tongue","drugRate":"reported","severity":"unknown"},{"effect":"urticaria","drugRate":"reported","severity":"unknown"},{"effect":"allergic conjunctivitis","drugRate":"reported","severity":"unknown"},{"effect":"dyspnea","drugRate":"reported","severity":"unknown"},{"effect":"angioedema","drugRate":"reported","severity":"unknown"},{"effect":"allergic dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"eye swelling","drugRate":"reported","severity":"unknown"},{"effect":"rash","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Lactation":"There are no data on the presence of lifitegrast in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lifitegrast from ocular administration is low [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered, along with the mothers clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra.","Pregnancy":"There are no available data on Xiidra use in pregnant women to inform any drug-associated risks. Intravenous (IV) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. Intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [RHOD], based on the area under the curve [AUC] level). Since human systemic exposure to lifitegrast following ocular administration of Xiidra at the RHOD is low, the applicability of animal findings to the risk of Xiidra use in humans during pregnancy is unclear [see Clinical Pharmacology (12.3)].DataAnimal DataLifitegrast administered daily by IV injection to rats, from premating through gestation day 17, caused an increase in mean pre-implantation loss and an increased incidence of several minor skeletal anomalies at 30 mg/kg/day, representing 5,400-fold the human plasma exposure at the RHOD of Xiidra, based on AUC. No teratogenicity was observed in the rat at 10 mg/kg/day (460-fold the human plasma exposure at the RHOD, based on AUC). In the rabbit, an increased incidence of omphalocele was observed at the lowest dose tested, mg/kg/day (400-fold the human plasma exposure at the RHOD, based on AUC), when ","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.","Paediatric use":"Safety and efficacy in pediatric patients below the age of 17 years have not been established."}},"trials":[],"aliases":[],"company":"Bausch Health","patents":[{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"May 9, 2029","useCode":"U-1880","territory":"US","drugProduct":false,"patentNumber":"8168655","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Apr 15, 2029","useCode":"U-1900","territory":"US","drugProduct":false,"patentNumber":"9447077","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Apr 15, 2029","useCode":"U-1880","territory":"US","drugProduct":true,"patentNumber":"8367701","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"May 17, 2026","useCode":"U-1880","territory":"US","drugProduct":false,"patentNumber":"8592450","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Oct 21, 2030","useCode":"","territory":"US","drugProduct":false,"patentNumber":"9890141","drugSubstance":true},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Nov 12, 2030","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8927574","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Jul 25, 2033","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9085553","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Dec 18, 2033","useCode":"","territory":"US","drugProduct":true,"patentNumber":"11058677","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"Oct 21, 2030","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9353088","drugSubstance":false},{"applNo":"N208073","source":"FDA Orange Book","status":"Active","expires":"May 17, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8084047","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=LIFITEGRAST","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:45:07.827546+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:45:07.827389+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Lifitegrast","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:45:15.568108+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:45:13.912025+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:45:06.136877+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LIFITEGRAST","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:45:14.511756+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:05.353782+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:05.353802+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:05.353807+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:45:16.021432+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Integrin alpha-L/beta-2 (LFA-1) antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:45:15.568040+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2048028/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:45:15.225521+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA208073","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:05.353809+00:00"}},"allNames":"xiidra","offLabel":[],"synonyms":["lifitegrast","SAR 1118-023","SAR 1118","SAR-1118","xiidra"],"timeline":[{"date":"2016-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SHIRE DEV LLC to Bausch And Lomb Inc"},{"date":"2016-07-11","type":"positive","source":"DrugCentral","milestone":"FDA approval (Shire Dev Llc)"},{"date":"2023-08-04","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"},{"date":"2026-05-17","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8084047 expires"},{"date":"2030-10-21","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 9890141 expires"}],"aiSummary":"Xiidra (Lifitegrast) is a small molecule lymphocyte function-associated antigen-1 (LFA-1) antagonist developed by Shire DEV LLC and currently owned by Bausch and Lomb Inc. It targets intercellular adhesion molecule 1 (ICAM-1) to treat tear film insufficiency. Xiidra was FDA-approved in 2016 and is available in both patented and generic forms. As a LFA-1 antagonist, Xiidra works by blocking the interaction between LFA-1 and ICAM-1, which plays a crucial role in the inflammatory response. It is used to treat dry eye disease.","approvals":[{"date":"2016-07-11","orphan":false,"company":"SHIRE DEV LLC","regulator":"FDA"}],"brandName":"Xiidra","ecosystem":[{"indication":"Tear film insufficiency","otherDrugs":[{"name":"ciclosporin","slug":"ciclosporin","company":"Novartis"},{"name":"crospovidone","slug":"crospovidone","company":""},{"name":"lutein","slug":"lutein","company":""},{"name":"macrogol","slug":"macrogol","company":"Braintree"}],"globalPrevalence":null}],"mechanism":{"target":"Intercellular adhesion molecule 1","novelty":"Follow-on","targets":[{"gene":"ICAM1","source":"DrugCentral","target":"Intercellular adhesion molecule 1","protein":"Intercellular adhesion molecule 1"},{"gene":"ITGAL","source":"DrugCentral","target":"Integrin alpha-L/beta-2","protein":"Integrin alpha-L"},{"gene":"ITGB2","source":"DrugCentral","target":"Integrin alpha-L/beta-2","protein":"Integrin beta-2"}],"moaClass":"Lymphocyte Function-Associated Antigen-1 Antagonists","modality":"Small Molecule","drugClass":"Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]","explanation":"Lifitegrast binds to the integrin LFA-1, cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known.","oneSentence":"Xiidra works by blocking the interaction between immune cells and the surface of the eye, reducing inflammation and promoting tear production.","technicalDetail":"Xiidra specifically targets the interaction between lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule 1 (ICAM-1), which is a key step in the inflammatory response and plays a crucial role in the pathogenesis of dry eye disease."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Lifitegrast","title":"Lifitegrast","extract":"Lifitegrast, sold under the brand name Xiidra, is a medication for the treatment of signs and symptoms of dry eye, a syndrome called keratoconjunctivitis sicca. Lifitegrast reduces inflammation by inhibiting inflammatory cell binding. It is often used as an alternative to ciclosporin for dry eye treatment including meibomian gland dysfunction and inflammatory dry eye.","wiki_history":"==History==\nLifitegrast was initially designed by Sunesis and developed by SARcode Bioscience which was acquired by Shire in 2013, which submitted a new drug application to the US Food and Drug Administration (FDA) in March 2015. The FDA granted Shire a priority review a month later, and requested additional clinical data, which were supplied in January 2016; approval was granted on 11 July 2016. Lifitegrast was approved by Health Canada in January 2018, and available in Canadian pharmacies as of March 2018.\n\nShire was acquired by Takeda Pharmaceutical Company in late 2018. In May 2019 Novartis reached an agreement to purchase the assets associated with lifitegrast. Novartis will pay Takeda an upfront payment of $3.4 billion, while the latter drugmaker is eligible for milestone payments of as much as $1.9 billion. Novartis noted that the drug amassed approximately $400 million in revenue in 2018. In 2023, Novartis sold the assets to Bausch + Lomb for $1.75 billion and eligible for an additional $750 million in payments linked to future sales for Xiidra as well as two pipeline assets."},"commercial":{"launchDate":"2016","_launchSource":"DrugCentral (FDA 2016-07-11, SHIRE DEV LLC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5174","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LIFITEGRAST","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LIFITEGRAST","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Lifitegrast","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T12:21:22.236729","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:45:18.717549+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"retinol","drugSlug":"retinol","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"sodium chloride","drugSlug":"sodium-chloride","fdaApproval":"1965-12-16","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"potassium iodide","drugSlug":"potassium-iodide","fdaApproval":"1979-11-09","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"acetylcysteine","drugSlug":"acetylcysteine","fdaApproval":"1963-09-14","patentExpiry":"May 8, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"inosine","drugSlug":"inosine","fdaApproval":"","relationship":"same-class"},{"drugName":"dexpanthenol","drugSlug":"dexpanthenol","fdaApproval":"1953-02-20","relationship":"same-class"},{"drugName":"alteplase","drugSlug":"alteplase","fdaApproval":"1996-06-18","relationship":"same-class"},{"drugName":"heparin","drugSlug":"heparin","fdaApproval":"1939-02-09","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"ascorbic acid","drugSlug":"ascorbic-acid","fdaApproval":"","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ciclosporin","drugSlug":"ciclosporin","fdaApproval":"1983-11-14","relationship":"same-class"},{"drugName":"mercaptamine","drugSlug":"mercaptamine","fdaApproval":"1994-08-15","relationship":"same-class"},{"drugName":"ocriplasmin","drugSlug":"ocriplasmin","fdaApproval":"2012-10-17","relationship":"same-class"},{"drugName":"sirolimus","drugSlug":"sirolimus","fdaApproval":"1999-09-15","patentExpiry":"Oct 28, 2040","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"riboflavin","drugSlug":"riboflavin","fdaApproval":"1953-02-20","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"varenicline","drugSlug":"varenicline","fdaApproval":"2006-05-10","patentExpiry":"Oct 19, 2035","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"lifitegrast","indications":{"approved":[{"name":"Tear film insufficiency","source":"DrugCentral","snomedId":46152009,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Bausch And Lomb Inc","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"retinol","brandName":"retinol","genericName":"retinol","approvalYear":"1953","relationship":"same-class"},{"drugId":"sodium-chloride","brandName":"sodium chloride","genericName":"sodium chloride","approvalYear":"1965","relationship":"same-class"},{"drugId":"potassium-iodide","brandName":"potassium iodide","genericName":"potassium iodide","approvalYear":"1979","relationship":"same-class"},{"drugId":"acetylcysteine","brandName":"acetylcysteine","genericName":"acetylcysteine","approvalYear":"1963","relationship":"same-class"},{"drugId":"inosine","brandName":"inosine","genericName":"inosine","approvalYear":"","relationship":"same-class"},{"drugId":"dexpanthenol","brandName":"dexpanthenol","genericName":"dexpanthenol","approvalYear":"1953","relationship":"same-class"},{"drugId":"alteplase","brandName":"alteplase","genericName":"alteplase","approvalYear":"1996","relationship":"same-class"},{"drugId":"heparin","brandName":"heparin","genericName":"heparin","approvalYear":"1939","relationship":"same-class"},{"drugId":"ascorbic-acid","brandName":"ascorbic acid","genericName":"ascorbic acid","approvalYear":"","relationship":"same-class"},{"drugId":"ciclosporin","brandName":"ciclosporin","genericName":"ciclosporin","approvalYear":"1983","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07490535","phase":"PHASE4","title":"This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye","status":"NOT_YET_RECRUITING","sponsor":"Pittsburgh Research Institute","startDate":"2026-03","conditions":["Ocular Surface Disease","Dry Eye Syndrome (DES)"],"enrollment":36,"completionDate":"2026-11"},{"nctId":"NCT07128628","phase":"PHASE2","title":"A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease","status":"RECRUITING","sponsor":"Bausch & Lomb Incorporated","startDate":"2025-10-24","conditions":["Dry Eye Disease"],"enrollment":423,"completionDate":"2026-11"},{"nctId":"NCT04354545","phase":"","title":"Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications","status":"RECRUITING","sponsor":"University of California, Los Angeles","startDate":"2021-04-01","conditions":["Glaucoma","Ocular Surface Disease"],"enrollment":75,"completionDate":"2026-12-01"},{"nctId":"NCT07111013","phase":"PHASE3","title":"A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease","status":"WITHDRAWN","sponsor":"Bausch & Lomb Incorporated","startDate":"2025-12","conditions":["Dry Eye Disease"],"enrollment":0,"completionDate":"2027-04"},{"nctId":"NCT07267481","phase":"PHASE4","title":"Switching From Xiidra to TRYPTYR","status":"NOT_YET_RECRUITING","sponsor":"Southern College of Optometry","startDate":"2025-12-15","conditions":["Dry Eye","Dry Eyes Chronic","Dry Eye Syndromes","Eye Diseases"],"enrollment":100,"completionDate":"2026-05-01"},{"nctId":"NCT07025811","phase":"PHASE4","title":"A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-07-09","conditions":["Dry Eye Disease"],"enrollment":350,"completionDate":"2026-04-30"},{"nctId":"NCT07040826","phase":"PHASE1","title":"Lifitegrast Eye Drops in Healthy Subjects：Phase I Study","status":"COMPLETED","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2022-12-06","conditions":["Dry Eye Syndromes"],"enrollment":24,"completionDate":"2023-04-10"},{"nctId":"NCT04030962","phase":"PHASE1,PHASE2","title":"A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease","status":"COMPLETED","sponsor":"AbbVie","startDate":"2020-03-04","conditions":["Dry Eye Disease","Dry Eye Syndrome"],"enrollment":292,"completionDate":"2022-03-18"},{"nctId":"NCT04734197","phase":"PHASE2","title":"A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Surface Ophthalmics, Inc.","startDate":"2021-01-11","conditions":["Dry Eye Disease"],"enrollment":349,"completionDate":"2022-03-25"},{"nctId":"NCT04297618","phase":"PHASE4","title":"The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers","status":"COMPLETED","sponsor":"University of Waterloo","startDate":"2021-07-07","conditions":["Dry Eye"],"enrollment":45,"completionDate":"2024-04-18"},{"nctId":"NCT06879782","phase":"PHASE3","title":"Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease","status":"RECRUITING","sponsor":"Lunan Better Pharmaceutical Co., LTD.","startDate":"2024-03-28","conditions":["Dry Eye Disease (DED)"],"enrollment":820,"completionDate":"2026-09-28"},{"nctId":"NCT05102409","phase":"PHASE2","title":"An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease 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