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).<\/p>\n
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 m and -79 m, respectively,were observed.<\/p>\n
Anti-VEGF treatment burden dropped by 61% and 85%, respectively.<\/p>\n
On the safety front, 18 serious adverse events were reported, one considered possibly related to RGX-314 (decrease in vision at month 11).<\/p>\n
A pivotal study in wet AMD should launch by year-end.<\/p>\n
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.<\/p>\n
Management will host a conference call this morning at 8:30 am ET to discuss the results.<\/p>\n
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Regenxbio announces positive one-year data on wet AMD gene therapy - Seeking Alpha<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" 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 m and -79 m, respectively,were observed. Continue reading