Regenxbio (RGNX) announced positive data from the Phase II fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration, or wet AMD. The fellow eye sub-study was designed to evaluate the safety and efficacy of a single dose of ABBV-RGX-314 using subretinal delivery in the fellow eye of previously treated patients. The second eye was treated with ABBV-RGX-314 approximately one year or more after administration of ABBV-RGX-314 in the first eye. At nine months post-administration of ABBV-RGX-314, key findings from the Phase II fellow eye sub-study include: 97% reduction in annualized anti-VEGF treatment burden; 100% of patients required either zero or one supplemental injection; 78% of patients were completely injection-free. Additionally, patients demonstrated sustained best-corrected visual acuity and central retinal thickness at nine months. ABBV-RGX-314 produced similar levels of aqueous protein in both treated eyes. As of September 11, 2024, ABBV-RGX-314 was well tolerated in the treated fellow eye with no drug related serious adverse events.
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