The following transcript has been edited for clarity.
Hi, my name is Vivienne S. Hau, MD, PhD, and I’m here at the American Society of Retina Specialists 2026 in beautiful Montreal.
I just reported on a novel study sponsored by Astellas, and on behalf of all the primary investigators, we discussed the phase 1b trial results of safety and efficacy of ASP7317. This is a human stem cell–derived retinal pigment epithelial (RPE) cell therapy for treatment of advanced geographic atrophy (GA). Now, throughout the study, we looked at safety first, and we were able to demonstrate that concerns of any sort of cellular graft failure or rejection, tumor growth, or elevation in intraocular pressure (IOP) was nonexistent within the patients themselves. And the most apparent was subconjunctival hemorrhage evidence after most vitrectomies and also some patients with diarrhea due to the pretreatment with immunomodulators.
[Regarding efficacy], we were able to show some really great results in that the best-corrected visual acuity (BCVA) of these patients for 3 cohorts, we had a small, medium, and large. The small and medium cohorts were extended out to 52 weeks and showed that BCVA continued to improve in comparison to the fellow eye, while not a true control, but that fellow eye actually had loss in letters over the same time period.
In addition, we looked at geographic atrophy area and we were able to show stabilization over time as well.
And then finally, we did a Patient Global Impression of Change (PGIC) questionnaire. And basically this is where we asked of all the participants what their thoughts were with the treatment. And most of the patients had said that the vision was either the same or improved. And this is the first time that in stem cell therapy, we were able to have a demonstration where patients actually said that they had good results.
So overall, this study showed that ASP7317 was safe and effective and patients felt like there was improvement. So this bodes well for the future as we will now continue on with future studies.
Thank you so much. RP







