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REGENXBIO Reports Encouraging Interim Results from Phase II AAVIATE® Trial of ABBV-RGX-314 for Wet AMD Treatment via Suprachoroidal Delivery

NextEdge Admin

17 Aug 2024

2 min 8 sec

REGENXBIO Inc. has announced promising interim results from the Phase II AAVIATE® trial of ABBV-RGX-314, a gene therapy treatment for wet age-related macular degeneration (AMD). This therapy, administered via suprachoroidal delivery, is designed as a one-time, in-office treatment that could significantly reduce the need for frequent anti-VEGF injections, a common burden for wet AMD patients.

In the trial, ABBV-RGX-314 has shown a strong safety profile, with over 100 patients across three dose levels tolerating the treatment well, and no serious drug-related adverse events reported. Particularly in dose level 3, the treatment demonstrated the most significant reduction in injection burden, achieving an 80% decrease in the annualized injection rate, with 50% of patients remaining injection-free. Additionally, no cases of intraocular inflammation were observed in patients who received short-course prophylactic topical steroid eye drops.

These results suggest that ABBV-RGX-314 could become a new standard of care by sustaining long-term vision health and addressing the challenges of chronic anti-VEGF therapy. The data supports the ongoing development of ABBV-RGX-314 as a potentially transformative treatment for chronic retinal conditions like wet AMD and diabetic retinopathy. The results were presented at the Hawaiian Eye and Retina meeting by Dr. John Pitcher of Eye Associates of New Mexico, highlighting the therapy's potential to meet significant unmet needs in this patient population.