{"id":"netarsudil","rwe":[{"pmid":"41842337","year":"2026","title":"Repurposing flufenamic acid as a putative PmrB-directed adjuvant to restore colistin activity in Klebsiella pneumoniae.","finding":"","journal":"Microbiology spectrum","studyType":"Clinical Study"},{"pmid":"41675443","year":"2026","title":"Netarsudil-associated conjunctival fragility.","finding":"","journal":"American journal of ophthalmology case reports","studyType":"Clinical Study"},{"pmid":"41632210","year":"2026","title":"Efficacy, effectiveness, and safety of rho-kinase inhibitors in uveitic glaucoma and ocular hypertension secondary to uveitis: a systematic review and meta-analysis.","finding":"","journal":"Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie","studyType":"Clinical Study"},{"pmid":"41580559","year":"2026","title":"Evaluation of cytotoxicity, wound healing, and anti-inflammatory effects of netarsudil on human corneal epithelial cells.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41562195","year":"2026","title":"The enantioselective total synthesis of ROCK-inhibitor (S)-Netarsudil (Rhopressa) via asymmetric organocatalysis.","finding":"","journal":"Organic & biomolecular chemistry","studyType":"Clinical Study"}],"_fda":{"id":"82acde68-4935-4dc9-82ff-9ff7f449f893","set_id":"7d4f0e3a-5b86-4c43-982a-813b22ae7e22","openfda":{"upc":["0370727497255"],"unii":["VL756B1K0U"],"route":["OPHTHALMIC","TOPICAL"],"rxcui":["1992868","1992873"],"spl_id":["82acde68-4935-4dc9-82ff-9ff7f449f893"],"brand_name":["Rhopressa"],"spl_set_id":["7d4f0e3a-5b86-4c43-982a-813b22ae7e22"],"package_ndc":["70727-497-25","70727-497-99"],"product_ndc":["70727-497"],"generic_name":["NETARSUDIL"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["NETARSUDIL MESYLATE"],"manufacturer_name":["Alcon Laboratories, Inc."],"application_number":["NDA208254"],"is_original_packager":[true]},"version":"17","pregnancy":["8.1 Pregnancy Risk Summary There are no available data on RHOPRESSA use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low [see Clinical Pharmacology ( 12.3 ) ] . Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures [see Data] . Data Animal Data Netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the recommended human ophthalmic dose [RHOD], based on C max ). The no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C max ). Netarsudil administered daily by intravenous injection to rabbits during organogenesis caused embryofetal lethality and decreased fetal weight at 5 mg/kg/day (1480-fold the plasma exposure at the RHOD, based on C max ). Malformations were observed at ≥3 mg/kg/day (1330-fold the plasma exposure at the RHOD, based on C max ), including thoracogastroschisis, umbilical hernia and absent intermediate lung lobe. The NOAEL for embryofetal development toxicity was 0.5 mg/kg/day (214-fold the plasma exposure at the RHOD, based on C max )."],"description":["11 DESCRIPTION Netarsudil is a Rho kinase inhibitor. Its chemical name is (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate. The molecular formula of the free base is C 28 H 27 N 3 O 3 and the molecular formula of the dimesylate is C 30 H 35 N 3 O 9 S 2 . The molecular weight of the free base is 453.54 and the molecular weight of the dimesylate is 645.74. The chemical structure is: Netarsudil dimesylate is a light yellow-to-white powder that is freely soluble in water, soluble in methanol, sparingly soluble in dimethyl formamide, and practically insoluble in dichloromethane and heptane. RHOPRESSA (netarsudil ophthalmic solution) 0.02% is supplied as a sterile, isotonic, buffered aqueous solution of netarsudil dimesylate with a pH of approximately 5 and an osmolality of approximately 295 mOsmol/kg. It is intended for topical application in the eye. Each mL of RHOPRESSA contains 0.2 mg of netarsudil (equivalent to 0.28 mg of netarsudil dimesylate). Benzalkonium chloride, 0.015%, is added as a preservative. The inactive ingredients are: boric acid, mannitol, sodium hydroxide to adjust pH, and water for injection. Netarsudil structural formula"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING RHOPRESSA ® (netarsudil ophthalmic solution) 0.02% (0.2 mg per mL) is supplied sterile in opaque white low density polyethylene bottles and tips with white polypropylene caps. 2.5 mL fill in a 4 mL container NDC # 70727-497-25 Storage: Store at 2°C to 8°C (36°F to 46°F) until opened. After opening, the product may be kept at 2°C to 25°C (36°F to 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C to 8°C (36°F to 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days."],"geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established."],"effective_time":"20260120","clinical_studies":["14 CLINICAL STUDIES RHOPRESSA 0.02% was evaluated in three randomized and controlled clinical trials, namely AR-13324-CS301 (NCT 02207491, referred to as Study 301), AR-13324-CS302 (NCT 02207621, referred to as Study 302), and AR-13324-CS304 (NCT 02558374, referred to as Study 304), in patients with open-angle glaucoma or ocular hypertension. Studies 301 and 302 enrolled subjects with baseline IOP lower than 27 mmHg and Study 304 enrolled subjects with baseline IOP lower than 30 mmHg. The treatment duration was 3 months in Study 301, 12 months in Study 302, and 6 months in Study 304. The three studies demonstrated up to 5 mmHg reductions in IOP for subjects treated with RHOPRESSA 0.02% once daily in the evening. For patients with baseline IOP < 25 mmHg, the IOP reductions with RHOPRESSA 0.02% dosed once daily were similar to those with timolol 0.5% dosed twice daily (see Table 1). For patients with baseline IOP equal to or above 25 mmHg, however, RHOPRESSA 0.02% resulted in smaller mean IOP reductions at the morning time points than timolol 0.5% for study visits on Days 43 and 90; the difference in mean IOP reduction between the two treatment groups was as high as 3 mmHg, favoring timolol. Table 1: Mean IOP Change from Baseline of Study Eye (mmHg) by Visit and Time This table was produced based on the observed data from all randomized subjects who did not have major protocol violations. The treatment differences and two-sided CIs for comparing Rhopressa QD vs Timolol BID 0.5% were based on Analysis of Covariance (ANCOVA) adjusted for baseline IOP. Study 301: Subjects with Baseline IOP < 25 mmHg Study 301: Subjects with Baseline IOP >= 25 and < 27 mmHg Study 302: Subjects with Baseline IOP < 25 mmHg Study 302: Subjects with Baseline IOP >= 25 and < 27 mmHg Study 304: Subjects with Baseline IOP < 25 mmHg Study 304: Subjects with Baseline IOP >= 25 and < 30 mmHg"],"pharmacokinetics":["12.3 Pharmacokinetics Absorption The systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of RHOPRESSA 0.02% once daily (one drop bilaterally in the morning) for 8 days. There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/mL) post dose on Day 1 and Day 8. Only one plasma concentration at 0.11 ng/mL for the active metabolite was observed for one subject on Day 8 at 8 hours post-dose. Metabolism After topical ocular dosing, netarsudil is metabolized by esterases in the eye."],"adverse_reactions":["6 ADVERSE REACTIONS The most common adverse reaction is conjunctival hyperemia (53%). Other common adverse reactions, approximately 20% include: corneal verticillata, instillation site pain, and conjunctival hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1‑800-757-9195, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common ocular adverse reaction observed in controlled clinical studies with RHOPRESSA dosed once daily was conjunctival hyperemia which was reported in 53% of patients. Six percent of patients discontinued therapy due to conjunctival hyperemia. Other common (approximately 20%) ocular adverse reactions reported were: corneal verticillata, instillation site pain, and conjunctival hemorrhage. Instillation site erythema, corneal staining, blurred vision, increased lacrimation, erythema of eyelid, and reduced visual acuity were reported in 5-10% of patients. Corneal Verticillata Corneal verticillata occurred in approximately 20% of the patients in controlled clinical studies. The corneal verticillata seen in RHOPRESSA-treated patients were first noted at 4 weeks of daily dosing. This reaction did not result in any apparent visual functional changes in patients. Most corneal verticillata resolved upon discontinuation of treatment. 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of RHOPRESSA. 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. Eye disorders : Epithelial corneal edema has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures (that could affect corneal endothelial function) [see Warnings and Precautions ( 5.1 )] ."],"contraindications":["4 CONTRAINDICATIONS None. None. ( 4 )"],"mechanism_of_action":["12.1 Mechanism of Action Netarsudil is a rho kinase inhibitor, which is believed to reduce IOP by increasing the outflow of aqueous humor through the trabecular meshwork. The exact mechanism is unknown."],"recent_major_changes":["","Warnings and Precautions, Epithelial Corneal Edema ( 5.1 ) 9/2024"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Netarsudil is a rho kinase inhibitor, which is believed to reduce IOP by increasing the outflow of aqueous humor through the trabecular meshwork. The exact mechanism is unknown. 12.3 Pharmacokinetics Absorption The systemic exposures of netarsudil and its active metabolite, AR-13503, were evaluated in 18 healthy subjects after topical ocular administration of RHOPRESSA 0.02% once daily (one drop bilaterally in the morning) for 8 days. There were no quantifiable plasma concentrations of netarsudil (lower limit of quantitation (LLOQ) 0.100 ng/mL) post dose on Day 1 and Day 8. Only one plasma concentration at 0.11 ng/mL for the active metabolite was observed for one subject on Day 8 at 8 hours post-dose. Metabolism After topical ocular dosing, netarsudil is metabolized by esterases in the eye."],"indications_and_usage":["1 INDICATIONS AND USAGE RHOPRESSA is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. RHOPRESSA ® is a Rho kinase inhibitor 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 5.1 Epithelial Corneal Edema Epithelial corneal edema, described as honeycomb or bullous, has been reported in some patients with pre-existing corneal stromal edema or following ocular procedures that could affect corneal endothelial function. Epithelial corneal edema typically resolves upon discontinuation of RHOPRESSA. Advise patients to notify their physician if they experience eye pain or decreased vision while using RHOPRESSA [see Adverse Reactions ( 6.2 ) and Patient Counselling Information ( 17 )] . 5.2 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 [see Patient Counseling Information ( 17 )]. 5.3 Use with Contact Lenses Contact lenses should be removed prior to instillation of RHOPRESSA and may be reinserted 15 minutes following its administration."],"clinical_studies_table":["
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil. Netarsudil was not mutagenic in the Ames test, in the mouse lymphoma test, or in the in vivo rat micronucleus test. Studies to evaluate the effects of netarsudil on male or female fertility in animals have not been performed."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION 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 minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions ( 5.2 )]. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma, infection, or decreased vision with or without eye pain), 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 RHOPRESSA. Use with Contact Lenses Advise patients that RHOPRESSA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of RHOPRESSA 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 5 minutes between applications. Missed Dose Advise patients that if one dose is missed, treatment should continue with the next dose in the evening. © 2024 Alcon Inc. U.S. Pat.: www.alconpatents.com ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, Texas 76134 USA 1-800-757-9195 Alcon.medinfo@alcon.com"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. Twice a day dosing is not well tolerated and is not recommended. If RHOPRESSA is to be used concomitantly with other topical ophthalmic drug products to lower IOP, administer each drug product at least 5 minutes apart [see Patient Counseling Information ( 17 )]. One drop into the affected eye(s) once daily in the evening. ( 2 )"],"spl_product_data_elements":["Rhopressa netarsudil NETARSUDIL MESYLATE NETARSUDIL BENZALKONIUM CHLORIDE MANNITOL BORIC ACID SODIUM HYDROXIDE WATER Bottle Label Sample Bottle Label Carton Label Bottle Label Sample Carton Label Sample Bottle Label"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing netarsudil 0.02% (0.2 mg/mL). Ophthalmic solution containing netarsudil 0.02%. ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on RHOPRESSA use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low [see Clinical Pharmacology ( 12.3 ) ] . Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures [see Data] . Data Animal Data Netarsudil administered daily by intravenous injection to rats during organogenesis caused abortions and embryofetal lethality at doses ≥0.3 mg/kg/day (126-fold the plasma exposure at the recommended human ophthalmic dose [RHOD], based on C max ). The no-observed-adverse-effect-level (NOAEL) for embryofetal development toxicity was 0.1 mg/kg/day (40-fold the plasma exposure at the RHOD, based on C max ). Netarsudil administered daily by intravenous injection to rabbits during organogenesis caused embryofetal lethality and decreased fetal weight at 5 mg/kg/day (1480-fold the plasma exposure at the RHOD, based on C max ). Malformations were observed at ≥3 mg/kg/day (1330-fold the plasma exposure at the RHOD, based on C max ), including thoracogastroschisis, umbilical hernia and absent intermediate lung lobe. The NOAEL for embryofetal development toxicity was 0.5 mg/kg/day (214-fold the plasma exposure at the RHOD, based on C max ). 8.2 Lactation Risk Summary There are no data on the presence of RHOPRESSA in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to netarsudil following topical ocular administration is low [see Clinical Pharmacology ( 12.3 )] , and it is not known whether measurable levels of netarsudil would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RHOPRESSA and any potential adverse effects on the breast-fed child from RHOPRESSA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients."],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-497-25 rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. Manufactured for: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 41079 NDC 70727-497-25 For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon 41077 See carton for storage conditions. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP: NDC 70727-497-99 SAMPLE - Not for Resale rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. Manufactured for: ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 41080 NDC 70727-497-99 SAMPLE - Not for Resale For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon 41078 See carton for storage conditions. Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP: NDC 70727-497-25 rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide toadjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300069021-1224 NDC 70727-497-25 For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 LOT: EXP.: 300069075 1224 Carton Label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70727-497-99 SAMPLE - Not for Resale rhopressa ® (netarsudil ophthalmic solution) 0.02% For topical application in the eye Sterile Rx only 2.5 mL Alcon Usual dosage: One drop in the affected eye(s) once daily in the evening. Each mL Rhopressa ® ophthalmic solution contains: Active: netarsudil mesylate 0.285 mg Preservative: benzalkonium chloride 0.15 mg Inactives: mannitol, boric acid, sodium hydroxide to adjust pH and water for injection. ALCON LABORATORIES, INC. Fort Worth, TX 76134 USA U.S. Pat: www.alconpatents.com Store at 2°C - 8°C (36°F - 46°F) until opened. After opening, the product may be kept at 2°C - 25°C (36°F - 77°F) for up to 6 weeks. If after opening the product is kept refrigerated at 2°C - 8°C (36°F - 46°F), then the product can be used until the expiration date stamped on the bottle. During shipment, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days. 300069020-1124 NDC 70727-497-99 SAMPLE - Not for Resale For topical application in the eye. rhopressa ® (netarsudil ophthalmic solution) 0.02% Rx only Sterile 2.5 mL Alcon See carton for storage conditions. Alcon Laboratories, Inc. Fort Worth, TX 76134 USA LOT: EXP.: 300069074 1124 Sample Carton Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of netarsudil. Netarsudil was not mutagenic in the Ames test, in the mouse lymphoma test, or in the in vivo rat micronucleus test. Studies to evaluate the effects of netarsudil on male or female fertility in animals have not been performed."]},"tags":[{"label":"Rho Kinase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Rho-associated protein kinase 2","category":"target"},{"label":"ROCK2","category":"gene"},{"label":"ROCK1","category":"gene"},{"label":"S01EE51","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Solution/ Drops","category":"form"},{"label":"LOE Approaching","category":"status"},{"label":"Ocular hypertension","category":"indication"},{"label":"Open-angle glaucoma","category":"indication"},{"label":"Alcon Labs Inc","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"CONJUNCTIVAL HYPERAEMIA","source":"FDA FAERS","actionTaken":"333 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"241 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"239 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"210 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"208 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"169 reports"},{"date":"","signal":"LACRIMATION INCREASED","source":"FDA FAERS","actionTaken":"154 reports"},{"date":"","signal":"INTRAOCULAR PRESSURE INCREASED","source":"FDA FAERS","actionTaken":"121 reports"},{"date":"","signal":"EYE PRURITUS","source":"FDA FAERS","actionTaken":"120 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"117 reports"}],"commonSideEffects":[{"effect":"conjunctival hyperemia","drugRate":"53%","_validated":true,"placeboRate":""},{"effect":"corneal verticillata","drugRate":"20%","_validated":true,"placeboRate":""},{"effect":"instillation site pain","drugRate":"20%","_validated":true,"placeboRate":""},{"effect":"conjunctival hemorrhage","drugRate":"20%","_validated":true,"placeboRate":""}],"specialPopulations":{"Pregnancy":"There are no available data on RHOPRESSA use in pregnant women to inform any drug associated risk; however, systemic exposure to netarsudil from ocular administration is low. Intravenous administration of netarsudil to pregnant rats and rabbits during organogenesis did not produce adverse embryofetal effects at clinically relevant systemic exposures.","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and other adult patients.","Paediatric use":"Safety and effectiveness in pediatric patients below the age of 18 years have not been established."},"discontinuationRates":[{"trial":"","drugArm":"6%","placeboArm":"","commonReason":"conjunctival hyperemia"}]},"trials":[],"aliases":[],"company":"Alcon Labs Inc","patents":[{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Jul 11, 2026","useCode":"U-1524","territory":"US","drugProduct":true,"patentNumber":"8450344","drugSubstance":true},{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Jul 11, 2026","useCode":"U-1524","territory":"US","drugProduct":true,"patentNumber":"9096569","drugSubstance":true},{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Jan 27, 2030","useCode":"U-1524","territory":"US","drugProduct":true,"patentNumber":"10174017","drugSubstance":true},{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Jul 11, 2026","useCode":"U-1524","territory":"US","drugProduct":false,"patentNumber":"10882840","drugSubstance":false},{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Nov 10, 2030","useCode":"U-1524","territory":"US","drugProduct":true,"patentNumber":"8394826","drugSubstance":true},{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Jan 27, 2030","useCode":"U-1524","territory":"US","drugProduct":false,"patentNumber":"11618748","drugSubstance":false},{"applNo":"N208254","source":"FDA Orange Book","status":"Active","expires":"Mar 14, 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( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1‑800-757-9195, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates obse","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:40:07.139889+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA208254","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:39:35.571210+00:00"}},"allNames":"rhopressa","offLabel":[],"synonyms":["rhokiinsa","netarsudil","netarsudil dimesylate","netarsudil mesylate","rhopressa","AR-13324"],"timeline":[{"date":"2017-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from AERIE PHARMACEUTICALS INC to Alcon Labs Inc"},{"date":"2017-12-18","type":"positive","source":"DrugCentral","milestone":"FDA approval (Aerie Pharmaceuticals Inc)"},{"date":"2019-11-19","type":"positive","source":"DrugCentral","milestone":"EMA approval (Aerie Pharmaceuticals Ireland Ltd)"},{"date":"2026-07-11","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8450344 expires"},{"date":"2030-01-27","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 10174017 expires"},{"date":"2030-11-10","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8394826 expires"},{"date":"2034-03-14","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 9931336 expires"}],"aiSummary":"Rhopressa (Netarsudil) is a small molecule Rho Kinase Inhibitor developed by AERIE PHARMACEUTICALS INC and currently owned by Alcon Labs Inc. 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