FDA clears IND application for RGX-314 in diabetic retinopathy
The FDA has cleared an investigational new drug application to evaluate the suprachoroidal delivery of RGX-314 in diabetic retinopathy, according to a press release.
Regenxbio is aiming to begin a phase 2 trial of the treatment later this year. The multicenter, open-label, randomized, controlled dose-escalation ALTITUDE trial will investigate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314.
Forty patients with diabetic retinopathy are expected to be enrolled across two cohorts and will be randomly assigned 3:1 to receive RGX-314 or control. The study will evaluate doses of 2.5 × 1011 GC per eye and 5 × 1011 GC per eye.
The primary endpoint will be the proportion of patients who experience an improvement in diabetic retinopathy severity at 48 weeks.
Regenxbio expects to report interim data in 2021.
Read more about