REGENXBIO (NASDAQ:RGNX) announces positive one-year data from cohorts 4 & 5 of its Phase 1/2a clinical trial evaluating gene therapy RGX-314 in patients with wet age-related macular degeneration (wet AMD).
The treatment effect was stable with a mean +4 letter change in best corrected visual acuity (BCVA) and -2 letters from baseline. Mean changes in retinal thickness of -61 µm and -79 µm, respectively, were observed.
Anti-VEGF treatment burden dropped by 61% and 85%, respectively.
On the safety front, 18 serious adverse events were reported, one considered possibly related to RGX-314 (decrease in vision at month 11).
A pivotal study in wet AMD should launch by year-end.
Another Phase 2 assessing suprachoroidal delivery of RGX-314 in wet AMD patients will commence this quarter with interim data from the first cohort expected by year-end.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
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