Data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) has demonstrated encouraging results.
RGX-314 is being developed by the US clinical-stage biotechnology company Regenixibo Inc., as a potential one-time treatment for wet AMD, diabetic retinopathy, and other additional chronic retinal conditions treated with anti-VEGF.
The treatment consists of the NAV AAV8 vector encoding an antibody fragment which inhibits VEGF, modifying the pathway for formation of new leaky blood vessels which lead to retinal fluid accumulation and vision loss.
The interim data was presented at the Retina Subspecialty Day program of the American Academy of Ophthalmology (AAO) 2019 Annual Meeting in San Francisco by Dr Jeffrey S. Heier, Co-President and Director of Retina Research at Ophthalmic Consultants of Boston and a primary investigator for the trial.
“Today’s interim update from the RGX-314 Phase I/IIa dose escalation study further demonstrates the significant reduction in anti-VEGF treatment burden and encouraging improvement or maintenance of effects on vision and retinal thickness in the three higher dose cohorts,” said Dr. Heier. “These effects are especially important as subjects in this study had been previously treated with chronic and burdensome anti- VEGF injections over several years, highlighting the severity of their disease. Today’s results further support the potential of RGX-314 gene therapy to have meaningful and durable effects in patients following a one-time intervention.”