EURETINA 2026: Eyestem interim Phase 2 results for clinical study of Eyecyte-RPE for GA secondary to dry AMD

In an interview at the 26th EURETINA Congress in Vienna, Austria, Ritesh Narula, MBBS, MS, discussed results from the Eyestem study of subretinal stem cell delivery for geographic atrophy (GA). Narula is a consultant ophthalmologist and vitreoretinal surgeon at LV Prasad Eye Institute. He is a co-investigator on the study and heads the institute’s Image Reading Centre.

Phase 1: Safety and early efficacy

Phase 1 was a dose-escalation safety study. It enrolled 9 patients with advanced GA across 3 arms, with 3 patients each receiving subretinal cell suspensions of 100,000, 200,000 or 300,000 cells. Safety of subretinal cell delivery was the primary focus, and efficacy was a secondary outcome measure.

Narula reported that the treatment was well tolerated. Patients gained a mean of about 11 letters of visual acuity. After approximately 18 months of follow-up, that gain has been maintained, and no patient has needed a repeat injection. The team has submitted the phase 1 results for publication.

Phase 2: Randomised controlled trial

Building on the phase 1 safety data, the investigators started a randomised controlled phase 2 trial. It uses a 2:1 allocation between a standard-of-care observation group and patients receiving subretinal injections. So far, about 13 patients have undergone the procedure.

Early results closely parallel those from phase 1, with a mean gain of close to 11 letters. Follow-up remains short; the longest is about 6 months, for the first patient treated. Across both phases, Narula said, “the visual acuity gains are quite consistent.”

Adverse events

In phase 2, one patient developed endophthalmitis and has been excluded from the final analysis for now. Another patient developed a macular hole but continues to respond well in terms of visual acuity. Apart from these events, patients have tolerated the procedure well.

Imaging role and possible drivers of outcomes

In phase 1, Narula served on the imaging board. The board decided whether patients were eligible and where the injection should be placed. In phase 2, he heads the image reading centre that analyses patient imaging.

Narula attributes the gains mainly to the fate-committed retinal pigment epithelium (RPE) cells used in the study. He said these cells set the results apart from those of another group working on similar subretinal stem cell suspensions. He also cited the team’s surgical technique, which is currently going through the publication process. Seven surgeons at about 7 sites have performed the surgery “quite comfortably and successfully.” Narula said this suggests the procedure can be replicated on a much larger scale.

Next steps

Narula said the team expected to complete phase 2 by the end of the third quarter of 2026. After that, it plans to apply for US Food and Drug Administration approval, and it hopes to begin a US trial in the second quarter of 2027. The team is also looking at commercial marketing of the product in India.