{"id":"open-label-ikervis","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Eye irritation/discomfort"},{"rate":"10-20","effect":"Conjunctival hyperemia"},{"rate":"10-15","effect":"Visual disturbance/blurred vision"},{"rate":"5-10","effect":"Eye pain"},{"rate":"5-10","effect":"Lacrimation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ikervis (cyclosporine 0.05% in cationic emulsion) is an immunosuppressant that inhibits T-cell activation and reduces inflammatory cytokine production in the lacrimal gland and ocular surface. The cationic emulsion formulation enhances corneal penetration and retention, allowing cyclosporine to reach deeper ocular tissues and restore tear production in patients with keratoconjunctivitis sicca (dry eye disease).","oneSentence":"Ikervis is a lipid emulsion eye drop that reduces inflammation and promotes tear production in dry eye disease by delivering cyclosporine to the ocular surface.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:47.816Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Severe keratoconjunctivitis sicca (dry eye disease) in adults"}]},"trialDetails":[{"nctId":"NCT04144413","phase":"PHASE3","title":"3-year Study in Dry Eye Disease Patients With Severe Keratitis Receiving Ikervis® (1mg/mL Ciclosporin)","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2019-05-31","conditions":"Dry Eye Disease With Severe Keratitis","enrollment":350},{"nctId":"NCT03237936","phase":"PHASE4","title":"Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis","status":"COMPLETED","sponsor":"Santen SAS","startDate":"2017-03-28","conditions":"Keratitis","enrollment":17},{"nctId":"NCT04492878","phase":"PHASE4","title":"Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment","status":"COMPLETED","sponsor":"Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA","startDate":"2020-02-04","conditions":"Dry Eye, Dry Eye Syndromes, Severe Keratitis","enrollment":25}],"_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":[],"phase":"phase_3","status":"active","brandName":"Open-label Ikervis","genericName":"Open-label Ikervis","companyName":"Santen SAS","companyId":"santen-sas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ikervis is a lipid emulsion eye drop that reduces inflammation and promotes tear production in dry eye disease by delivering cyclosporine to the ocular surface. Used for Severe keratoconjunctivitis sicca (dry eye disease) in adults.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}