Eyestem Research Pvt Ltd has raised funds, in a significantly oversubscribed funding round, to support the next stage of development for its investigational retinal pigment epithelial (RPE) cell therapy, Eyecyte-RPE™.
The capital will enable completion of the ongoing Phase 2 clinical trial in India and support preparations for filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).
Eyecyte-RPE is being developed for patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). In the recently concluded Phase 1 trial in subjects with advanced GA and severe vision loss, the therapy showed a strong safety profile with no serious adverse events and early signs of clinical benefit, with an average improvement of 15.8 letters for six subjects at the end of six months and an average improvement of 11 letters in the first two subjects over a one-year period. The upcoming Phase 2 trial will further assess the efficacy and safety of the product in a larger group of subjects with moderate GA and vision loss.
The company has submitted its Phase 1 clinical study report to the Central Drugs Standard Control Organisation (CDSCO) and is awaiting approval to initiate Phase 2.
