The FDA has signed off on a Phase 2 clinical trial, ALTITUDE, evaluating REGENXBIO’s (NASDAQ:RGNX) gene therapy RGX-314 in patients with diabetic retinopathy (DR).
The primary endpoint is the proportion of participants showing improved DR at week 48 as measured by a scale called ETDRS-DRSS.
Dosing should begin in H2. Preliminary data should be available in 2021.
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