{"id":"difluprednate-0-05","safety":{"commonSideEffects":[{"rate":null,"effect":"Elevated intraocular pressure"},{"rate":null,"effect":"Ocular irritation or discomfort"},{"rate":null,"effect":"Cataract formation (with prolonged use)"},{"rate":null,"effect":"Secondary infection"}]},"_chembl":{"chemblId":"CHEMBL4303220","moleculeType":"Small molecule","molecularWeight":"508.56"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Difluprednate is a fluorinated prednisolone derivative with enhanced glucocorticoid receptor binding affinity, making it more potent than conventional corticosteroids. It reduces inflammation by inhibiting phospholipase A2, decreasing prostaglandin and leukotriene production, and suppressing immune cell infiltration and cytokine release in ocular tissues. The 0.05% ophthalmic formulation is designed for topical delivery to treat anterior segment inflammation.","oneSentence":"Difluprednate is a potent corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:50.512Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Inflammation and pain following ocular surgery"},{"name":"Anterior uveitis"},{"name":"Allergic conjunctivitis"},{"name":"Corneal injury"}]},"trialDetails":[{"nctId":"NCT06271772","phase":"PHASE3","title":"Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, San Francisco","startDate":"2024-07-01","conditions":"Bacterial Keratitis","enrollment":60},{"nctId":"NCT04097730","phase":"PHASE3","title":"Steroids and Cross-linking for Ulcer Treatment","status":"COMPLETED","sponsor":"Thomas M. Lietman","startDate":"2020-09-24","conditions":"Keratitis Bacterial","enrollment":280},{"nctId":"NCT04631315","phase":"PHASE4","title":"Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.","status":"COMPLETED","sponsor":"Laboratorios Poen","startDate":"2019-03-24","conditions":"Cataract","enrollment":255},{"nctId":"NCT04687800","phase":"PHASE4","title":"Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery","status":"TERMINATED","sponsor":"Cathleen McCabe MD","startDate":"2020-12-01","conditions":"Cataract","enrollment":1},{"nctId":"NCT01939691","phase":"PHASE4","title":"Macular Edema Nepafenac vs. Difluprednate Uveitis Trial","status":"TERMINATED","sponsor":"University of California, San Francisco","startDate":"2018-09-12","conditions":"Uveitis, Macular Edema","enrollment":9},{"nctId":"NCT03693989","phase":"PHASE3","title":"Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification","status":"COMPLETED","sponsor":"Laboratorios Sophia S.A de C.V.","startDate":"2018-10-04","conditions":"Cataract","enrollment":178},{"nctId":"NCT01124045","phase":"PHASE3","title":"Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2010-08","conditions":"Cataracts, Inflammation","enrollment":80},{"nctId":"NCT01276223","phase":"PHASE2","title":"Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2011-02","conditions":"Dry Eye Disease","enrollment":722},{"nctId":"NCT01201798","phase":"PHASE3","title":"Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2010-10","conditions":"Endogenous Anterior Uveitis","enrollment":111},{"nctId":"NCT01244334","phase":"PHASE4","title":"Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.","status":"COMPLETED","sponsor":"Edward J. Holland","startDate":"2009-03","conditions":"Cataracts, Corneal Edema, Retinal Structural Change, Deposit and Degeneration","enrollment":52},{"nctId":"NCT00429923","phase":"PHASE3","title":"Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002a)","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"","conditions":"Inflammation","enrollment":219},{"nctId":"NCT00430092","phase":"PHASE3","title":"Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"","conditions":"Inflammation","enrollment":219},{"nctId":"NCT00407225","phase":"PHASE2","title":"Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"1999-12","conditions":"Inflammation","enrollment":24},{"nctId":"NCT00406341","phase":"PHASE3","title":"Study of Difluprednate Ophthalmic Emulsion in Postoperative Inflammation","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"2004-04","conditions":"Inflammation","enrollment":200},{"nctId":"NCT00406497","phase":"PHASE2","title":"Study of Difluprednate Ophthalmic Emulsion in the Treatment of Postoperative Inflammation","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"2003-04","conditions":"Inflammation","enrollment":24},{"nctId":"NCT00407056","phase":"PHASE3","title":"Study of Difluprednate Ophthalmic Emulsion in the Treatment of Severe Uveitis","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"2002-08","conditions":"Uveitis, Panuveitis","enrollment":20},{"nctId":"NCT00406887","phase":"PHASE3","title":"Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"2002-08","conditions":"Anterior Uveitis, Panuveitis","enrollment":140},{"nctId":"NCT00405496","phase":"PHASE2","title":"Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis","status":"COMPLETED","sponsor":"Sirion Therapeutics, Inc.","startDate":"2000-03","conditions":"Anterior Uveitis","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":33,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["PRO-145"],"phase":"phase_3","status":"active","brandName":"Difluprednate 0.05%","genericName":"Difluprednate 0.05%","companyName":"Laboratorios Sophia S.A de C.V.","companyId":"laboratorios-sophia-s-a-de-c-v","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Difluprednate 0.05% is a small molecule used to treat various ocular conditions, including inflammation, cataract, dry eye disease, anterior uveitis, and panuveitis. It is administered as a treatment for inflammation following ocular surgery.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}