{"id":"bepotastine-besilate-ophthalmic-solution-1-5","rwe":[],"tags":[],"phase":"phase_1","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":["6 ADVERSE REACTIONS The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2 to 5% of subjects were eye irritation, headache, and nasopharyngitis. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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 clinical practice. The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2 to 5% of subjects were eye irritation, headache, and nasopharyngitis. 6.2 Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of bepotastine besilate ophthalmic solution. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat."],"contraindications":["4 CONTRAINDICATIONS Bepotastine besilate ophthalmic solution is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [ see Adverse Reactions (6.2) ]. Hypersensitivity to any component of this product."]},"status":"active","trials":["NCT04776096","NCT00424398","NCT01450176","NCT00586664","NCT01337557","NCT04693429","NCT01128556","NCT00586625","NCT01346371"],"aliases":["Bepreve"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"aiSummary":"","brandName":"Bepotastine besilate ophthalmic solution 1.5%","companyId":"mccabe-vision-center","ecosystem":[],"mechanism":{"drugClass":"","explanation":"1 INDICATIONS & USAGE Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.","oneSentence":"12.1 Mechanism of Action Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells."},"commercial":null,"references":[],"biosimilars":[],"companyName":"McCabe Vision Center","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"Bepotastine besilate ophthalmic solution 1.5%","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04776096","phase":"Phase 4","title":"PHASE IV, MULTICENTRIC, DOUBLE-BLIND, RANDOMIZED, CONTROLLED,60 DAYS, PARALLEL GROUPS, SUPERIORITY STUDY, TO COMPARE THE EFFECTIVENESS AND TOXICITY OF BEPOTASTINE 1.5% PF vs. OLOPATADINE 0.2% WITH BAK","status":"COMPLETED","sponsor":"Laboratorios Poen","isPivotal":false,"enrollment":97,"indication":"Allergic Conjunctivitis","completionDate":"2022-08-18"},{"nctId":"NCT00424398","phase":"Phase 2","title":"A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","isPivotal":true,"enrollment":107,"indication":"Conjunctivitis, Allergic","completionDate":""},{"nctId":"NCT01450176","phase":"NA","title":"Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID","status":"COMPLETED","sponsor":"McCabe Vision Center","isPivotal":false,"enrollment":30,"indication":"Eye Allergies","completionDate":"2011-12"},{"nctId":"NCT00586664","phase":"Phase 3","title":"","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","isPivotal":true,"enrollment":130,"indication":"Allergic Conjunctivitis","completionDate":"2008-06"},{"nctId":"NCT01337557","phase":"Phase 4","title":"Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses","status":"UNKNOWN","sponsor":"Hom, Milton M., OD, FAAO","isPivotal":false,"enrollment":24,"indication":"Allergic Conjunctivitis","completionDate":"2011-11"},{"nctId":"NCT04693429","phase":"Phase 1","title":"Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Vo","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","isPivotal":false,"enrollment":22,"indication":"Safety, Tolerability","completionDate":"2020-12-08"},{"nctId":"NCT01128556","phase":"Phase 4","title":"The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing","status":"COMPLETED","sponsor":"North Texas Institute for Clinical Trials","isPivotal":false,"enrollment":30,"indication":"Histamine Responsive Allergy Patients","completionDate":"2010-06"},{"nctId":"NCT00586625","phase":"Phase 3","title":"","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","isPivotal":true,"enrollment":861,"indication":"Allergic Conjunctivitis","completionDate":""},{"nctId":"NCT01346371","phase":"Phase 4","title":"The Effect of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer","status":"COMPLETED","sponsor":"Minnesota Eye Consultants, P.A.","isPivotal":false,"enrollment":40,"indication":"Allergic Conjunctivitis","completionDate":"2012-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"OPHTHALMIC","dosage_text":"2 DOSAGE & ADMINISTRATION Instill one drop of bepotastine besilate ophthalmic solution into the affected eye(s) twice a day. Remove contact lenses prior to instillation of bepotastine besilate ophthalmic solution. Instill one drop into the affected eye(s) twice a day. (2) Remove contact lenses prior to instillation of Bepotastine besilate ophthalmic solution."},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Ophthalmology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}