Eyecyte-RPE / Eyestem Research - LARVOL DELTA

Eyestem Raises Funds to Advance Eyecyte-RPE Through Phase 2 Clinical Trial and Towards US IND (Business News This Week) - "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)...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."

IND • New P2 trial • Age-related Macular Degeneration

Eyestem announces completion of Ph 1 study of its RPE Cell Therapy (BioSpectrum India) - P1/2a | N=54 | NCT06394232 | Sponsor: Eyestem Research Pvt. Ltd. | "Bengaluru-based startup Eyestem Research has announced the completion of its phase one study for its investigational retinal pigment epithelium (RPE) cell therapy, Eyecyte-RPE. The clinical study report of the study has been submitted to the Central Drugs Standard Control Organisation (CDSCO) for permission to start the phase 2 study....'Our phase 1/2a trial demonstrated an excellent safety profile with no serious adverse events, while delivering clinically meaningful vision improvement—an average of 15.8 letters in the first six patients over six months'."

P1 data • Trial completion • Age-related Macular Degeneration

Eyestem’s Eyecyte-RPE Trial Shows Vision Rescue for Geographic Atrophy Patients (Businesswire) - P1/2 | N=54 | NCT06394232 | Sponsor: Eyestem Research Pvt. Ltd. | "Eyestem Research...is pleased to announce significant vision improvement in Phase 1 trials of its investigational drug, Eyecyte-RPE, in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). All patients across three cohorts were dosed without any serious adverse events. The first six showed an average 14.9-letter gain in ETDRS vision tests within 4–6 months, with early signs of disease reversal seen in some retinal scans—marking an advance in ophthalmic cell therapy."

P1 data • Dry Age-related Macular Degeneration