Eyecyte-RPE Phase 2 interim data presented at EURetina 2026 in Vienna, Austria, show continuing visual acuity gains in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). Eyestem Research Private Limited is a biotechnology company developing advanced, scalable cell therapy solutions for blindness caused by dry AMD. It announced the findings from India on 5 October 2026.
Dr. Ritesh Narula, Co-Principal Investigator of the trial, presented the interim results at the EURetina 2026 conference (https://www.euretina.org). The data come from a randomized Phase 2 clinical trial of Eyecyte-RPE™, Eyestem’s cell therapy candidate for GA. According to the company, the visual acuity gains first observed in Phase 1 have continued with longer follow-up.
As the Phase 2 trial progresses, Eyestem said it is ready to file a US Investigational New Drug (IND) application in early 2027 to treat geographic atrophy and related vision loss. That timeline is a forward-looking statement. The Eyecyte-RPE Phase 2 study is ongoing, so the results reported here are interim.
Eyecyte-RPE Phase 2 Trial Design and Safety Profile Presented at EURetina 2026
The randomized controlled Phase 2 trial has recruited 24 subjects. Fifteen are in the treatment arm, and nine are in the natural history control arm. Eyestem did not disclose the trial’s registry identifier in the announcement.
Eyestem reports that Eyecyte-RPE has shown an excellent overall safety profile in the Phase 2 study. The company says this is consistent with the safety profile in the preceding Phase 1 clinical trial. The announcement does not give adverse event counts or severity grades, so those items are marked “Not disclosed” in the tables below.
Seven different surgeons have performed the surgeries using Eyestem’s patent-pending surgical technique. In our editorial view, the involvement of several surgeons is a relevant detail for an Eyecyte-RPE Phase 2 program heading toward a US IND filing. The company has not disclosed the number of trial sites or procedural specifics.
Eyecyte-RPE Phase 2 Visual Acuity Results: Letter Gains at 6, 12 and 18 Months
The Phase 1 gains have continued with longer follow-up. Seven subjects showed an improvement of 13 letters at 12 months versus baseline. Four subjects who completed 18 months maintained an improvement of 15.3 letters.
The visual acuity gains in Phase 2 are consistent with those seen in Phase 1. Three subjects who completed six months of follow-up demonstrated a 16-letter gain versus baseline. This is the first Eyecyte-RPE Phase 2 efficacy signal described in the announcement.
Across both phases, 12 subjects completed six months of follow-up, with an average improvement of 13.8 letters. The release reports gains in letters versus baseline but does not name the visual acuity chart used. It also gives no control-arm acuity values, p-values or confidence intervals. These items are listed as “Not disclosed.”
What Eyecyte-RPE Phase 2 Findings Mean for Geographic Atrophy Patients
Dr. Jogin Desai, Founder and CEO of Eyestem, said the early Phase 2 results build on the Phase 1 results and mark an important milestone for the geographic atrophy program. He said the company is encouraged that gains were sustained over longer follow-up alongside a good safety profile. He added that the findings give greater confidence that Eyecyte-RPE could “meaningfully change the treatment landscape” for patients worldwide. This is a company statement, not an independent assessment.
The sample sizes behind each figure are small. They are 3 subjects at six months in Phase 2, 7 at 12 months, 4 at 18 months, and 12 at six months across both phases. The Eyecyte-RPE Phase 2 results are interim, and the announcement does not compare treatment-arm outcomes with the natural history control arm. Readers should treat the numbers as early signals rather than confirmed efficacy.
Eyecyte-RPE Phase 2 Next Steps: US IND Application Planned for Early 2027
Eyestem intends to file its US IND application in early 2027 for treating geographic atrophy and related vision loss. Filing would be a regulatory step toward further clinical development in the United States. It would not be an approval, and the announcement does not give any decision timeline.
Announcement Key Facts
| Attribute | Detail |
|---|---|
| Company | Eyestem Research Private Limited |
| Product | Eyecyte-RPE™ |
| Indication | Geographic atrophy secondary to dry AMD |
| Announcement date | 5 October 2026 |
| Dateline | India |
| Conference | EURetina 2026, Vienna, Austria |
| Presenter | Dr. Ritesh Narula, Co-Principal Investigator |
| Quoted executive | Dr. Jogin Desai, Founder and CEO |
| Planned regulatory step | US IND application, early 2027 (forward-looking) |
Eyecyte-RPE Phase 2 Enrollment and Safety
| Parameter | Value |
|---|---|
| Design | Randomized controlled |
| Total subjects recruited | 24 |
| Treatment arm | 15 |
| Natural history control arm | 9 |
| Surgeons involved | 7 |
| Surgical technique | Patent-pending |
| Safety profile | Excellent overall, consistent with Phase 1 |
| Adverse event counts | Not disclosed |
| Trial identifier | Not disclosed |
Visual Acuity Outcomes Versus Baseline
| Cohort | Follow-up | Subjects | Improvement |
|---|---|---|---|
| Phase 1 | 12 months | 7 | 13 letters |
| Phase 1 | 18 months | 4 | 15.3 letters (maintained) |
| Phase 2 | 6 months | 3 | 16 letters |
| Phase 1 and 2 combined | 6 months | 12 | 13.8 letters (average) |
