Texas Retina Associates’ Ashkan M. Abbey, MD, recently presented at the 41st Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) held in Seattle. ASRS is the largest organization of retina specialists in the world with over 3,000 members in all 50 U.S. states, the District of Columbia, Puerto Rico, and 63 countries.
Dr. Abbey spoke about “Subretinal Delivery of RGX-314: Gene Therapy for Neovascular Age-Related Macular Degeneration.” RGX-314 is being developed as a one-time treatment for wet (neovascular) and is delivered by subretinal injection during vitrectomy surgery. It was designed to neutralize endothelial growth factor (VEGF) activity, helping to prevent formation of new leaky blood vessels and retinal fluid accumulation in patients with wet AMD.
In his presentation Dr. Abbey discussed the initial results of a Phase II pharmacodynamic study looking at two medication manufacturing techniques for RGX-314: the hyperstack (HS) technique used in the initial clinical research process vs. the commercial-scale process bioreactor (BRX) technique. The advantage of the BRX process is that it demonstrates robust scalability and increased capacity to supply treatment to global patient populations. Both high-dose and low-dose cohorts were examined.
The study found that protein levels were similar between the two cohorts at 6 months, and the majority of patients in the trial did not require additional injections for wet AMD after receiving the gene therapy. ABBV-RGX-314, manufactured by the BRX process, demonstrated a similar clinical profile to that produced by the HS process. Common adverse events in the study eye also were similar. The cohorts showed expected and similar ABBV-RGX-314 protein-level expression.
Texas Retina is actively recruiting for the Phase III pivotal trials for this gene therapy: ASCENT and ATMOSPHERE. Click here to learn more about those two studies.