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
Uncategorized