Corneal Endothelial Cell Therapy
Our initial candidate treats dystrophies that cause corneal blindness.
Healthy cells from a donor cornea are propagated in a novel, multistep, proprietary, and patented process. Cultured cells from a single donor can be manufactured to produce treatments for more than 1,000 recipient eyes. The cell therapy procedure is minimally invasive and can be performed relatively rapidly, with a recovery period of approximately 2 to 3 hours for patients.
Pipeline
In Japan, early clinical research1 followed by dose-ranging and confirmatory clinical trials have successfully demonstrated the safety, efficacy, and tolerability of our lead product candidate. We have received regulatory approval from Japan’s PMDA.
In the US, we have completed enrollment and dosing of our Phase 1 /2 trial, and expect topline results in early 2025. We are in process of clinical development planning for the EU.
Reference
- Kinoshita S, Koizumi N, Ueno M, et al. Injection of cultured cells with a ROCK inhibitor for bullous keratopathy. N Engl J Med. 2018;378(11):995-1003.