{"id":"bimatoprost","rwe":[{"pmid":"41862140","year":"2026","title":"Smart Lipid-Based Nanocarrier System for the Topical Delivery of Ocular Therapeutics Bio-Interfacing, Physicochemical Diversity, and Routing Barriers.","finding":"","journal":"European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences","studyType":"Clinical Study"},{"pmid":"41738452","year":"2026","title":"Fixed Triple-Combination Bimatoprost/Brimonidine/Timolol Versus Separate Administration in Glaucoma: Randomized Clinical Trial.","finding":"","journal":"Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics","studyType":"Clinical Study"},{"pmid":"41697065","year":"2026","title":"Differential Effects of EP3, FP, and EP2 Receptor Agonists on Orbital Adipogenesis in a 3D Spheroid Model of Thyroid Eye Disease.","finding":"","journal":"Current eye research","studyType":"Clinical Study"},{"pmid":"41665855","year":"2026","title":"Computational study of Durysta(®) implant for glaucoma treatment: drug dispersion and aqueous humor flow in the anterior chamber.","finding":"","journal":"Drug delivery and translational research","studyType":"Clinical Study"},{"pmid":"41621045","year":"2026","title":"Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results.","finding":"","journal":"Ophthalmology and therapy","studyType":"Clinical Study"}],"_fda":{"id":"3ba5f1e6-a8f2-4205-bb03-b968326dbc08","set_id":"059a60ec-aee2-4c13-8307-05cd92e8729a","openfda":{"nui":["N0000175454","M0017805"],"unii":["QXS94885MZ"],"route":["OPHTHALMIC"],"rxcui":["308739"],"spl_id":["3ba5f1e6-a8f2-4205-bb03-b968326dbc08"],"brand_name":["Bimatoprost"],"spl_set_id":["059a60ec-aee2-4c13-8307-05cd92e8729a"],"package_ndc":["65862-802-44","65862-802-05","65862-802-10"],"product_ndc":["65862-802"],"generic_name":["BIMATOPROST"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Prostaglandins [CS]"],"substance_name":["BIMATOPROST"],"pharm_class_epc":["Prostaglandin Analog [EPC]"],"manufacturer_name":["Aurobindo Pharma Limited"],"application_number":["ANDA205537"],"is_original_packager":[true]},"version":"2","pregnancy":["8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [AUC] levels). These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure at the recommended clinical dose (based on blood AUC levels). No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure at the recommended clinical dose (based on blood AUC levels). Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure at the recommended human ophthalmic dose [RHOD], based on AUC). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure at the RHOD, based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure at the RHOD, based on AUC). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure at the RHOD, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure at the RHOD, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. These effects were observed at exposures at least 41 times the human systemic exposure at the RHOD, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure at the RHOD, based on AUC)."],"overdosage":["10 OVERDOSAGE No information is available on overdosage in humans. If overdose with bimatoprost ophthalmic solution 0.03% occurs, treatment should be symptomatic. In oral (by gavage) mouse and rat general toxicity studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m 2 is at least 70 times higher than the accidental dose of one bottle of bimatoprost ophthalmic solution 0.03% for a 10 kg child."],"description":["11 DESCRIPTION Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is ( Z )-7-[(1 R ,2 R ,3 R ,5 S )-3,5­-Dihydroxy-2-[(1 E ,3 S )-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5- N -ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C 25 H 37 NO 4 . Its chemical structure is: Bimatoprost is a white to off-white color powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost ophthalmic solution 0.03% contains Active: bimatoprost 0.3 mg/mL; Inactives: benzalkonium chloride 0.05 mg/mL, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost ophthalmic solution 0.03% is a clear, colorless sterile solution. Practically free from visible particles packed in opaque white LDPE container with LDPE nozzle and turquoise color HDPE cap. 0.03% 2.5 mL fill in 5 mL bottle NDC 65862-802-44 5 mL fill in 10 mL bottle NDC 65862-802-05 7.5 mL fill in 10 mL bottle NDC 65862-802-10 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, bimatoprost ophthalmic solution, 0.03% can be used until the expiration date stamped on the bottle."],"geriatric_use":["8.5 Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients."],"pediatric_use":["8.4 Pediatric Use Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use."],"effective_time":"20230717","clinical_studies":["14 CLINICAL STUDIES In clinical studies of patients with open angle glaucoma or ocular hypertension with a mean baseline IOP of 26 mmHg, the IOP-lowering effect of bimatoprost ophthalmic solution 0.03% once daily (in the evening) was 7 to 8 mmHg."],"pharmacokinetics":["12.3 Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily to both eyes of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing. There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma. Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes oxidation, N­-deethylation and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes. The total blood clearance of bimatoprost was 1.5 L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Pigmentation [see Warnings and Precautions (5.1) ] • Eyelash Changes [see Warnings and Precautions (5.2) ] • Intraocular Inflammation [see Warnings and Precautions (5.3) ] • Macular Edema [see Warnings and Precautions (5.4) ] • Hypersensitivity [see Contraindications (4) ] Most common adverse reaction (45%) is conjunctival hyperemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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 the 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 clinical trials, the most frequent events associated with the use of bimatoprost ophthalmic solution 0.03% occurring in approximately 15% to 45% of patients, in descending order of incidence, included conjunctival hyperemia, growth of eyelashes, and ocular pruritus. Approximately 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse events occurring in approximately 3 to 10% of patients, in descending order of incidence, included ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, pigmentation of the periocular skin, blepharitis, cataract, superficial punctate keratitis, periorbital erythema, ocular irritation, and eyelash darkening. The following ocular adverse events reported in approximately 1 to 3% of patients, in descending order of incidence, included: eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, and conjunctival edema. In less than 1% of patients, intraocular inflammation was reported as iritis. Systemic adverse events reported in approximately 10% of patients were infections (primarily colds and upper respiratory tract infections). The following systemic adverse events reported in approximately 1 to 5% of patients, in descending order of incidence, included headaches, abnormal liver function tests, asthenia and hirsutism. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of bimatoprost ophthalmic solution 0.03%. 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. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to bimatoprost ophthalmic solution, or a combination of these factors, include: abnormal hair growth, asthma-like symptoms, dizziness, dyspnea, eyelid edema, hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis, hypertension, nausea, and periorbital and lid changes associated with periorbital fat atrophy leading to skin tightness, deepening of the eyelid sulcus, eyelid ptosis, enophthalmos and eyelid retraction; and skin discoloration (non-periocular)."],"contraindications":["4 CONTRAINDICATIONS Bimatoprost ophthalmic solution 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions (6.2) ]. Hypersensitivity."],"labor_and_delivery":["8.2 Lactation Risk Summary It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the RHOD (on a m 2 g/m basis), however no animal data is available at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bimatoprost ophthalmic solution 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution 0.03%."],"mechanism_of_action":["12.1 Mechanism of Action Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. 12.3 Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily to both eyes of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing. There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma. Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes oxidation, N­-deethylation and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes. The total blood clearance of bimatoprost was 1.5 L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces."],"indications_and_usage":["1 INDICATIONS AND USAGE Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost ophthalmic solution 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. ( 5.2 ) 5.1 Pigmentation Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with bimatoprost ophthalmic solution 0.03% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 5.2 Eyelash Changes Bimatoprost ophthalmic solution 0.03% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. 5.3 Intraocular Inflammation Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis). 5.4 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution. Bimatoprost ophthalmic solution 0.03% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. 5.5 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 5.6 Contact Lens Use Bimatoprost ophthalmic solution 0.03% contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to instillation of bimatoprost ophthalmic solution 0.03% and may be reinserted 15 minutes following its administration."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times the human systemic exposure at the RHOD, respectively, based on blood AUC levels). Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests. Impairment of Fertility Bimatoprost did not impair fertility in male or female rats at doses up to 0.6 mg/kg/day (at least 103 times the human systemic exposure at the RHOD, based on blood AUC levels)."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Also inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution 0.03%. Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with bimatoprost ophthalmic solution 0.03%. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. Handling the Container Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of bimatoprost ophthalmic solution 0.03%. Contact Lens Use Advise patients that bimatoprost ophthalmic solution 0.03% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of bimatoprost ophthalmic solution 0.03% and may be reinserted 15 minutes following its administration. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. Bimatoprost ophthalmic solution 0.03% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours. Bimatoprost ophthalmic solution 0.03% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. One drop in the affected eye(s) once daily in the evening. ( 2 )"],"spl_product_data_elements":["Bimatoprost Bimatoprost BIMATOPROST BIMATOPROST BENZALKONIUM CHLORIDE CITRIC ACID MONOHYDRATE SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE SODIUM CHLORIDE WATER SODIUM HYDROXIDE HYDROCHLORIC ACID"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing bimatoprost 0.3 mg/mL. Ophthalmic solution containing 0.3 mg/mL of bimatoprost. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. ( 8.4 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [AUC] levels). These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure at the recommended clinical dose (based on blood AUC levels). No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure at the recommended clinical dose (based on blood AUC levels). Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure at the recommended human ophthalmic dose [RHOD], based on AUC). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure at the RHOD, based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure at the RHOD, based on AUC). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure at the RHOD, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure at the RHOD, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. These effects were observed at exposures at least 41 times the human systemic exposure at the RHOD, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure at the RHOD, based on AUC). 8.2 Lactation Risk Summary It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the RHOD (on a m 2 g/m basis), however no animal data is available at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bimatoprost ophthalmic solution 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution 0.03%. 8.4 Pediatric Use Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. 8.5 Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients."],"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 2.5 mL Container Label NDC 65862-802-44 Bimatoprost Ophthalmic Solution 0.03% For Use in the Eyes Only Rx only 2.5 mL AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 2.5 mL Container Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 2.5 mL Container-Carton (1 Bottle) NDC 65862-802-44 Bimatoprost Ophthalmic Solution 0.03% For Use in the Eyes Only Rx only Sterile 2.5 mL AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 2.5 mL Container-Carton (1 Vial)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 5 mL Container Label NDC 65862-802-05 Bimatoprost Ophthalmic Solution 0.03% For Use in the Eyes Only Rx only 5 mL AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 5 mL Container Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 5 mL Container-Carton (1 Bottle) NDC 65862-802-05 Bimatoprost Ophthalmic Solution 0.03% For Use in the Eyes Only Rx only Sterile 5 mL AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 5 mL Container-Carton (1 Vial)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 7.5 mL Container Label NDC 65862-802-10 Bimatoprost Ophthalmic Solution 0.03% For Use in the Eyes Only Rx only 7.5 mL AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 7.5 mL Container Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 7.5 mL Container-Carton (1 Bottle) NDC 65862-802-10 Bimatoprost Ophthalmic Solution 0.03% For Use in the Eyes Only Rx only Sterile 7.5 mL AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.03% - 7.5 mL Container-Carton (1 Vial)"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times the human systemic exposure at the RHOD, respectively, based on blood AUC levels). Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests. Impairment of Fertility Bimatoprost did not impair fertility in male or female rats at doses up to 0.6 mg/kg/day (at least 103 times the human systemic exposure at the RHOD, based on blood AUC levels)."]},"tags":[{"label":"Prostaglandin Analog","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Aldo-keto reductase family 1 member C3","category":"target"},{"label":"AKR1C3","category":"gene"},{"label":"PTGFR","category":"gene"},{"label":"S01EE03","category":"atc"},{"label":"Topical","category":"route"},{"label":"Ophthalmic","category":"route"},{"label":"Intracameral","category":"route"},{"label":"Implant","category":"form"},{"label":"Solution","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Hypertrichosis of eyelid","category":"indication"},{"label":"Ocular hypertension","category":"indication"},{"label":"Open-angle glaucoma","category":"indication"},{"label":"Approved 2000s","category":"decade"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"4071 reports"},{"date":"","signal":"TREATMENT FAILURE","source":"FDA FAERS","actionTaken":"3077 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"2333 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"1841 reports"},{"date":"","signal":"MADAROSIS","source":"FDA FAERS","actionTaken":"1386 reports"},{"date":"","signal":"EYE PRURITUS","source":"FDA FAERS","actionTaken":"1320 reports"},{"date":"","signal":"ERYTHEMA OF EYELID","source":"FDA FAERS","actionTaken":"1012 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"937 reports"},{"date":"","signal":"HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"851 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"835 reports"}],"commonSideEffects":[{"effect":"conjunctival hyperemia","drugRate":"45%","severity":"common","_validated":true},{"effect":"ocular pruritus","drugRate":"15% to 45%","severity":"common","_validated":true},{"effect":"growth of eyelashes","drugRate":"15% to 45%","severity":"common","_validated":true},{"effect":"ocular dryness","drugRate":"10%","severity":"common","_validated":true},{"effect":"visual disturbance","drugRate":"10%","severity":"common","_validated":true},{"effect":"ocular burning","drugRate":"10%","severity":"common","_validated":true},{"effect":"foreign body sensation","drugRate":"10%","severity":"common","_validated":true},{"effect":"eye pain","drugRate":"10%","severity":"common","_validated":true},{"effect":"pigmentation of the periocular skin","drugRate":"10%","severity":"common","_validated":true},{"effect":"blepharitis","drugRate":"10%","severity":"common","_validated":true},{"effect":"cataract","drugRate":"10%","severity":"common","_validated":true},{"effect":"superficial punctate keratitis","drugRate":"10%","severity":"common","_validated":true},{"effect":"periorbital erythema","drugRate":"10%","severity":"common","_validated":true},{"effect":"ocular irritation","drugRate":"10%","severity":"common","_validated":true},{"effect":"eyelash darkening","drugRate":"10%","severity":"common","_validated":true},{"effect":"eye discharge","drugRate":"3%","severity":"mild","_validated":true},{"effect":"tearing","drugRate":"3%","severity":"mild","_validated":true},{"effect":"photophobia","drugRate":"3%","severity":"mild","_validated":true},{"effect":"allergic conjunctivitis","drugRate":"3%","severity":"mild","_validated":true},{"effect":"asthenopia","drugRate":"3%","severity":"mild","_validated":true},{"effect":"increases in iris pigmentation","drugRate":"3%","severity":"mild","_validated":true},{"effect":"conjunctival edema","drugRate":"3%","severity":"mild","_validated":true},{"effect":"intraocular inflammation","drugRate":"<1%","severity":"mild","_validated":true},{"effect":"infections","drugRate":"10%","severity":"common","_validated":true},{"effect":"headaches","drugRate":"5%","severity":"mild","_validated":true},{"effect":"abnormal liver function tests","drugRate":"5%","severity":"mild","_validated":true},{"effect":"asthenia","drugRate":"5%","severity":"mild","_validated":true},{"effect":"hirsutism","drugRate":"5%","severity":"mild","_validated":true}],"contraindications":["Aphakia","Cystoid macular edema","Disease of liver","Iritis","Liver function tests abnormal","Macular retinal edema","Pseudophakia","Uveitis"],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies of bimatoprost ophthalmic solution, 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience.","Geriatric use":"No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.","Paediatric use":"Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. No new safety issues were observed in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition."}},"trials":[],"aliases":[],"patents":[{"applNo":"N022184","source":"FDA Orange Book","status":"Active","expires":"Jun 13, 2027","useCode":"","territory":"US","drugProduct":true,"patentNumber":"7851504","drugSubstance":true},{"type":"Formulation","number":"10314780","applicant":"THEA PHARMA INC","territory":"US","tradeName":"ZOLYMBUS","expiryDate":"2036-06-08"},{"type":"Method of Use","number":"8206737","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2027-04-07"},{"type":"Method of Use","number":"9980974","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2034-10-31"},{"type":"Formulation","number":"9492316","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2034-10-31"},{"type":"Formulation","number":"7799336","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2029-04-24"},{"type":"Compound","number":"8629185","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2031-07-15"},{"type":"Formulation","number":"10441543","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2026-12-19"},{"type":"Formulation","number":"9149428","applicant":"ABBVIE INC","territory":"US","tradeName":"DURYSTA","expiryDate":"2026-12-19"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$19.7271/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$7,102","description":"BIMATOPROST 0.03% EYE DROPS","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T15:40:50.847749","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BIMATOPROST","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:52:58.509277+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:52:58.509185+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bimatoprost","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:53:05.544385+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:53:04.016735+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:52:58.583253+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:52:57.551070+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BIMATOPROST","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:53:04.451204+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":"2026-04-19T23:52:55.269476+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:55.269579+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:55.269596+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":"2026-04-19T23:53:06.080652+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Prostanoid FP receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:53:05.544297+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200963/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:53:05.186984+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA205537","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:52:55.269600+00:00"}},"allNames":"lumigan","offLabel":[],"synonyms":["lumigan","bimatoprost","prostamide"],"timeline":[{"date":"2001-03-16","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"2002-03-08","type":"positive","source":"DrugCentral","milestone":"EMA approval"},{"date":"2008-12-24","type":"positive","source":"FDA Orange Book","milestone":"Latisse approved — 0.03%"},{"date":"2019-04-12","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 6 manufacturers approved"},{"date":"2020-03-04","type":"positive","source":"FDA Orange Book","milestone":"Durysta approved — 10MCG"},{"date":"2025-09-09","type":"positive","source":"FDA Orange Book","milestone":"Zolymbus approved — 0.01%"},{"date":"2027-06-13","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 7851504 expires"}],"aiSummary":"Lumigan (Bimatoprost) is a prostaglandin analog developed by originally developed by GlaxoSmithKline, now owned by Abbvie. It targets the Aldo-keto reductase family 1 member C3 enzyme and is used to treat hypertrichosis of eyelid, ocular hypertension, and open-angle glaucoma. Lumigan is a small molecule drug that has been FDA-approved since 2001 and is available as a generic medication from multiple manufacturers. As a prostaglandin analog, it works by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure. Despite its commercial availability, key safety considerations include potential eye irritation and changes in eye color.","brandName":"Lumigan","ecosystem":[{"indication":"Hypertrichosis of eyelid","otherDrugs":[],"globalPrevalence":null},{"indication":"Ocular hypertension","otherDrugs":[{"name":"betaxolol","slug":"betaxolol","company":"Alcon"},{"name":"brimonidine","slug":"brimonidine","company":""},{"name":"brinzolamide","slug":"brinzolamide","company":"Alcon Pharms Ltd"},{"name":"carteolol","slug":"carteolol","company":""}],"globalPrevalence":1280000000},{"indication":"Open-angle glaucoma","otherDrugs":[{"name":"acetazolamide","slug":"acetazolamide","company":"Teva Branded Pharm"},{"name":"apraclonidine","slug":"apraclonidine","company":"Alcon"},{"name":"betaxolol","slug":"betaxolol","company":"Alcon"},{"name":"brimonidine","slug":"brimonidine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Aldo-keto reductase family 1 member C3","novelty":"Follow-on","targets":[{"gene":"AKR1C3","source":"DrugCentral","target":"Aldo-keto reductase family 1 member C3","protein":"Aldo-keto reductase family 1 member C3"},{"gene":"PTGFR","source":"DrugCentral","target":"Prostaglandin F2-alpha receptor","protein":"Prostaglandin F2-alpha receptor"}],"modality":"Small Molecule","drugClass":"Prostaglandin Analog [EPC]","explanation":"Bimatoprost, prostaglandin analog, is synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Elevated IOP presents major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.","oneSentence":"Lumigan works by increasing the outflow of fluid from the eye to reduce pressure.","technicalDetail":"Lumigan (Bimatoprost) is a prostaglandin analog that acts as an agonist to the prostaglandin F2α receptor, leading to increased outflow of aqueous humor through the uveoscleral pathway and decreased intraocular pressure.","_target_confidence":0.5},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Bimatoprost","title":"Bimatoprost","extract":"Bimatoprost, sold under the brand name Lumigan among others, is a medication used to treat high pressure inside the eye including glaucoma. Specifically it is used for open angle glaucoma when other agents are not sufficient. It may also be used to increase the size of the eyelashes. It is used as an eye drop and effects generally occur within four hours."},"commercial":{"launchDate":"2001","_launchSource":"DrugCentral (FDA 2001-03-16, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/371","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BIMATOPROST","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BIMATOPROST","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Bimatoprost","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"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T09:03:34.240823","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:53:08.657806+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"latanoprost","drugSlug":"latanoprost","fdaApproval":"1996-06-05","patentExpiry":"Sep 12, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"travoprost","drugSlug":"travoprost","fdaApproval":"2001-03-16","patentExpiry":"Sep 20, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"tafluprost","drugSlug":"tafluprost","fdaApproval":"2012-02-10","patentExpiry":"May 28, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"latanoprostene bunod","drugSlug":"latanoprostene-bunod","fdaApproval":"2017-11-02","patentExpiry":"Feb 21, 2029","patentStatus":"Patent 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or ocular hypertension"}],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(966)"],"currentOwner":"Abbvie","drugCategory":"mature","labelChanges":[],"relatedDrugs":[{"drugId":"latanoprost","brandName":"latanoprost","genericName":"latanoprost","approvalYear":"1996","relationship":"same-class"},{"drugId":"travoprost","brandName":"travoprost","genericName":"travoprost","approvalYear":"2001","relationship":"same-class"},{"drugId":"tafluprost","brandName":"tafluprost","genericName":"tafluprost","approvalYear":"2012","relationship":"same-class"},{"drugId":"latanoprostene-bunod","brandName":"latanoprostene bunod","genericName":"latanoprostene bunod","approvalYear":"2017","relationship":"same-class"},{"drugId":"netarsudil","brandName":"netarsudil","genericName":"netarsudil","approvalYear":"2017","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04499248","phase":"PHASE1,PHASE2","title":"AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular 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