New treatment for diabetic retinopathy enters Phase II Trial

REGENXBIO has announced the start of Phase II trial for its RGX-314 to treat chronic retinal conditions including diabetic retinopathy and wet macular degeneration. RGX-314 is administered via SCS Microinjector for targeted delivery of gene therapy to the back of the eye and into the retina. It is a one-time, in-office procedure.

Current therapies involve anti-VEGF injections but these injections require frequent administration. Researchers hope that RGX-314 will only need to be administered once.

The Phase II trial looks to enroll around 40 patients who have diabetic retinopathy across two cohorts. The primary endpoint of the trial is to see the number of patients that see an improvement in their diabetic retinopathy based upon the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at 48 weeks. Researchers also will look for efficacy and possible adverse side effects. Data from the trial will be reported in 2021.