Drugs / Eyecyte-RPE™
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06394232 | Jun 2024 → Apr 2025 overdue | age-related macular degeneration, diffuse secondary choroid atrophy | Eyestem Research Pvt. Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-01-25 | Eyestem Research Pvt. Ltd. | Regulatory Eyestem receives CDSCO approval to initiate Phase 2 randomised, controlled human trials of Eyecyte-RPE eyestem.com ↗
Eyestem Research Pvt Ltd, a biotechnology company, has received approval from the Central Drugs Standard Control Organisation (CDSCO) to initiate the clinical trial of its investigational retinal pigment epithelium (RPE) cell therapy, Eyecyte-RPE™ in India. |
| 2025-06-18 | Eyestem Research Pvt. Ltd. | Results Eyestem Announces completion of Phase one of its RPE cell therapy with promising efficacy and safety outcomes eyestem.com ↗
“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,” said Dr Rajani Battu, Chief Medical Officer, Eyestem. |
| 2025-04-15 | Eyestem Research Pvt. Ltd. | Results Eyestem’s Eyecyte-RPE™ Trial Shows Vision Rescue for Geographic Atrophy Patients eyestem.com ↗
With all patient injections completed across three cohorts without any Serious Adverse Events (SAE), the first six patients had an average improvement of 14.9 letters in ETDRS standard vision tests within 4 to 6 months post-transplantation. |
| 2025-01-10 | Eyestem Research Pvt. Ltd. | Results Eyestem announces interim safety and efficacy data from ongoing Phase I trial using Eyecyte-RPE for the treatment of Geographic Atrophy patients, in an International Conference "The Future is Here II, Exploring New Frontiers of Ocular Research", organized by LV Prasad Eye Institute, Hyderabad b/w Jan 9-12. eyestem.com ↗
The safety and efficacy results from six patients are outstanding, with an excellent safety profile observed. |
| 2024-10-23 | Eyestem Research Pvt. Ltd. | Results Eyestem receives positive recommendation from the Drug Safety Monitoring Board(DSMB) for the first set of patient injections for its pioneering Dry AMD treatment eyestem.com ↗
We are thrilled to receive DSMB approval for the first cohort and expect to begin injections for the second cohort in the next few weeks. |
| 2024-04-02 | Eyestem Research Pvt. Ltd. | Regulatory Eyestem to Start Human Trials for its Pioneering Dry AMD Treatment eyestem.com ↗ |
| 2023-06-05 | Eyestem Research Pvt. Ltd. | Regulatory Eyestem files for IND approval for its product to treat Geographic Atrophy, the largest cause of incurable blindness in the world for people over 50 eyestem.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eyecyte-RPE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06394232 ↗ |
| Action | Restore | “can help replace the damaged or lost retinal pigment epithelial (RPE) cells” NCT06394232 ↗ |
| Modality | Cell therapy | “stem cell replacement therapy” NCT06394232 ↗ |
| Route | Other | “single-dose subretinal injection” NCT06394232 ↗ |