{"id":"kpi-121-ophthalmic-suspension","safety":{"commonSideEffects":[{"rate":null,"effect":"Instillation site discomfort"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Eye irritation"}]},"_chembl":{"chemblId":"CHEMBL3644505","moleculeType":"Small molecule","molecularWeight":"529.02"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"KPI-121 is formulated as a mucoadhesive suspension designed to deliver anti-inflammatory and neuroprotective effects to the ocular surface. The drug targets inflammatory mediators and nerve fiber dysfunction associated with dry eye disease and other ocular surface conditions, with enhanced corneal penetration and residence time due to its proprietary formulation technology.","oneSentence":"KPI-121 is a topical ophthalmic suspension that reduces ocular inflammation and promotes corneal healing through inhibition of transient receptor potential vanilloid 1 (TRPV1) and modulation of inflammatory pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:17:55.921Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dry eye disease (keratoconjunctivitis sicca)"},{"name":"Ocular surface 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":"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},{"nctId":"NCT03596723","phase":"PHASE3","title":"KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children","status":"TERMINATED","sponsor":"Kala Pharmaceuticals, Inc.","startDate":"2018-07-03","conditions":"Ocular Inflammation","enrollment":2}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"KPI-121 Ophthalmic Suspension","genericName":"KPI-121 Ophthalmic Suspension","companyName":"Kala Pharmaceuticals, Inc.","companyId":"kala-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"KPI-121 is a topical ophthalmic suspension that reduces ocular inflammation and promotes corneal healing through inhibition of transient receptor potential vanilloid 1 (TRPV1) and modulation of inflammatory pathways. Used for Dry eye disease (keratoconjunctivitis sicca), Ocular surface inflammation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}