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Tuesday, August 25, 2020

REGENXBIO on go with mid-stage study of gene therapy for diabetic retinopathy

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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