REGENXBIO Announced Interim Data from Phase II AAVIATE Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery
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- REGENXBIO Inc. (NASDAQ:RGNX) today announced positive interim data from the Phase II AAVIATE® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions. A single ABBV-RGX-314 gene therapy treatment has the potential to become a new standard-of-care option among anti-VEGF treatments by sustaining vision health long term and overcoming the clinical challenges of managing wet AMD due to the treatment burden of chronic anti-VEGF injections
- ABBV-RGX-314 continues to be well tolerated in over 100 patients from three dose levels with no drug-related serious adverse events
- ABBV-RGX-314 in over 50 patients at third dose level demonstrated highest reduction in treatment burden:
- 80% reduction in annualized injection rate
- 50% injection-free
- Zero cases of intraocular inflammation observed in patients that received short-course prophylactic topical steroid eye drops