Adverum Biotechnologies Presents Positive Ixo-vec Clinical Data from the 26-Week Interim Analysis of the LUNA Phase 2 Trial at the 2024 ASRS Annual Meeting
Excerpt from the Press Release:
– 6E10 combined with local prophylaxis selected for Phase 3 pivotal trials, with a favorable safety profile and potential best-in-class product profile at 26 weeks
– Efficacy: 76% of 6E10 patients were injection free, with maintained visual acuity and fluid control
– Safety: 100% of 6E10 difluprednate-alone patients had no or minimal inflammation, and none received corticosteroids for treatment of inflammation beyond the scheduled prophylaxis
– Patient Preference Survey: 88% of patients indicated a preference for Ixo-vec over their prior anti-VEGF injections, and 93% would opt to receive Ixo-vec in the other eye
– Efficacy and safety with 6E10 at 26-weeks similar to or better than in OPTIC at 2E11, where clinical benefit was demonstrated beyond 3 years
– LUNA 9-month landmark analysis and pivotal trial design update anticipated in 4Q 2024
– Webcast to be held today Wednesday, July 17 at 8:00 a.m. EST
REDWOOD CITY, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today announced results from the landmark 26-week interim analysis of the ongoing LUNA Phase 2 trial of Ixo-vec in patients with wet age-related macular degeneration (AMD). These data are being presented today by Dr. Charles Wykoff at the 42nd Annual Meeting of the American Society of Retinal Specialists in Stockholm, Sweden.
“In LUNA, the 26-week landmark analysis demonstrates that Ixo-vec has a potential best-in-class product profile, combining a favorable safety profile and an industry-leading proportion of patients who are free of injections, supporting our selection of the 6E10 dose with a local prophylactic regimen for Phase 3 pivotal studies,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies. “Our pre-specified Patient Preference Survey, presented today for the first time, supports what we have long believed, that patients want to preserve long-term vision and be free of injections and are not deterred by corticosteroid prophylaxis. Over the next couple quarters, we plan to present data at important 9 month and 1 year timepoints. In OPTIC, nearly all patients who were injection free at 1 year continued to be injection free beyond 3 years.”
“The LUNA trial was designed to answer a key question – whether lower doses of Ixo-vec combined with enhanced prophylactic regimens could demonstrate a product profile consistent with or better than that demonstrated in OPTIC.
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