The senior partner at Retina Vitreous Associates Medical Group discussed efficacy and safety data from the phase 2 AAVIATE trial.
“When we looked at the results of this group with topical steroids, it really reduced the incidence of any intraocular inflammation at all and a marked reduction in episcleritis. With the Sub-Tenon's, there were 2 cases of a minimal degree of inflammation. So, we now have a better prophylactic steroid regimen to be able to go forward with perhaps even higher doses. But, at least at this time, the suprachoroidal delivery has been well-tolerated and really causes a stabilization of retinal vision and thickness.”
New data from the phase 2 AAVIATE trial (NCT04514653) evaluating suprachoroidal delivery of RGX-314 (REGENXBIO) gene therapy had a favorable safety profile with some evidence of a dose-dependent response in patients with neovascular age-related macular degeneration (nAMD). David Boyer, MD, senior partner, Retina Vitreous Associates Medical Group, presented the data update at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting, held July 29-August 1 in Seattle, Washington.
There were no serious adverse events related to the treatment.The highest reduction in treatment burden was seen in cohort 3, in which patients received the highest dose of RGX-314, had an 85% reduction in annualized injection rate, and had a 67% injection-free rate. Along with the use of prophylactic topical steroids, there were no cases of intraocular inflammation in cohort 3.
CGTLive spoke with Boyer to learn more about the updated data from the trial. He touched on the new prophylactic steroid regimen and how it seems to be safe and effective and may enable higher doses of the gene therapy to be administered.