Adverum Biotechnologies Completes Phase 3 Screening for Ixo-vec Wet AMD Trial
Adverum Biotechnologies Completes Phase 3 Screening for Ixo-vec Wet AMD Trial

Adverum Biotechnologies Completes Phase 3 Screening for Ixo-vec Wet AMD Trial

News summary

Adverum Biotechnologies is nearing the completion of screening for its pivotal Phase 3 ARTEMIS trial evaluating Ixo-vec, a gene therapy for wet age-related macular degeneration (AMD), with full enrollment now expected by the fourth quarter of 2025, ahead of prior expectations. The ARTEMIS trial compares a single administration of Ixo-vec to aflibercept injections every eight weeks in both treatment-naïve and previously treated patients, with topline data anticipated by the first quarter of 2027. Ixo-vec is designed as a one-time intravitreal injection to provide long-term therapeutic levels, reduce treatment burden, and improve patient compliance compared to frequent anti-VEGF injections. The therapy has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, highlighting its potential to transform wet AMD treatment. Despite its innovative approach, Adverum faces financial challenges, including negative margins and cash flow issues, which impact its stock rating. Overall, the advancement of the ARTEMIS trial positions Adverum as a leader in ocular gene therapy with the potential to significantly improve vision outcomes for wet AMD patients.

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