{"id":"kpi-121-1-0","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Eye discomfort"},{"rate":null,"effect":"Increased intraocular pressure"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KPI-121 is a 1.0% formulation of difluprednate, a potent corticosteroid, delivered via Kala's proprietary mucoadhesive technology (AMPPLIFY) that enhances corneal and conjunctival penetration while prolonging ocular residence time. This allows for reduced dosing frequency while maintaining anti-inflammatory efficacy for dry eye disease and post-operative inflammation.","oneSentence":"KPI-121 is a topical ophthalmic formulation that reduces ocular surface inflammation and promotes tear film stability through a mucoadhesive delivery system.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:05.962Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease"},{"name":"Post-operative ocular inflammation"}]},"trialDetails":[{"nctId":"NCT02163824","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-05","conditions":"Ocular Infections, Irritations and Inflammations","enrollment":380},{"nctId":"NCT02793817","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2016-06","conditions":"Post Surgical Ocular Inflammation and Pain","enrollment":520},{"nctId":"NCT02245516","phase":"NA","title":"Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-07","conditions":"Retinal Vein Occlusion, Diabetic Macular Edema","enrollment":16}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["KPI-121 1.0% Ophthalmic Suspension","Loteprednol etabonate 1.0%"],"phase":"phase_3","status":"active","brandName":"KPI-121 1.0%","genericName":"KPI-121 1.0%","companyName":"Kala Pharmaceuticals, Inc.","companyId":"kala-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KPI-121 is a topical ophthalmic formulation that reduces ocular surface inflammation and promotes tear film stability through a mucoadhesive delivery system. Used for Dry eye disease, Post-operative ocular inflammation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}