{"id":"kpi-121-0-25-ophthalmic-suspension","safety":{"commonSideEffects":[{"rate":null,"effect":"Blurred vision"},{"rate":null,"effect":"Eye irritation"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Ocular discomfort"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KPI-121 is a novel ophthalmic suspension containing a proprietary mucoadhesive polymer system that enhances corneal and conjunctival residence time. The formulation is designed to reduce inflammation and provide lubrication to the ocular surface, addressing both the inflammatory and aqueous-deficient components of dry eye disease. The mucoadhesive properties allow for prolonged therapeutic contact with the eye surface, potentially improving efficacy compared to standard eye drops.","oneSentence":"KPI-121 is a suspension formulation designed to reduce ocular inflammation and improve tear film stability in dry eye disease through sustained ocular surface contact.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:18:04.722Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease (keratoconjunctivitis sicca)"},{"name":"Post-operative ocular inflammation"}]},"trialDetails":[{"nctId":"NCT03616899","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With DED","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2018-07-10","conditions":"Kerato Conjunctivitis Sicca","enrollment":901},{"nctId":"NCT02813265","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2016-06","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":918},{"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":"NCT02218489","phase":"PHASE2","title":"Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-07","conditions":"Blepharitis","enrollment":206},{"nctId":"NCT02188160","phase":"PHASE2","title":"Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2014-06","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":150},{"nctId":"NCT02819284","phase":"PHASE3","title":"Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease","status":"COMPLETED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2016-06","conditions":"Dry Eye Syndromes, Keratoconjunctivitis Sicca","enrollment":909},{"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":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Loteprednol etabonate","Loteprednol etabonate 0.25%"],"phase":"phase_3","status":"active","brandName":"KPI-121 0.25% Ophthalmic Suspension","genericName":"KPI-121 0.25% Ophthalmic Suspension","companyName":"Kala Pharmaceuticals, Inc.","companyId":"kala-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KPI-121 is a suspension formulation designed to reduce ocular inflammation and improve tear film stability in dry eye disease through sustained ocular surface contact. Used for Dry eye disease (keratoconjunctivitis sicca), Post-operative ocular inflammation.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}