Adverum Biotechnologies, Inc. announced updated data from the OPTIC extension study of patients with wet AMD during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting in San Francisco, California. A summary of previously announced aflibercept protein levels from the LUNA study was also presented.
“We are pleased to be leading innovation for patients with wet AMD through the development of a treatment option that has the potential to be safe, efficacious and much less burdensome for patients,” stated Laurent Fischer, MD, president and CEO of Adverum Biotechnologies. “These efforts are now supported by the most mature dataset in wet AMD IVT gene therapy, with the OPTIC safety and efficacy data now sustained out to 3 years. Ixo-vec demonstrated a robust improvement in outcome measures while maintaining a favorable safety profile, particularly at the 2E11 dose, which we have advanced to our phase 2 LUNA trial. We are particularly encouraged by the continuous and consistent aflibercept protein levels observed at up to 4.5 years post-treatment. These data highlight the potential for patients to experience life-long clinical benefit after a single IVT treatment with minimal or no need for additional injections and showcase the potentially transformative impact of gene therapy.”
OPTIC 3-year Extension Data Highlights
- An oral presentation titled “ADVM-022 Intravitreal Gene Therapy for Neovascular AMD: Preliminary Data from the Phase 2 LUNA Trial and 3-Year Results From the Phase 1 OPTIC-Extension Trial” was presented today by Carl D. Regillo, M.D. FACS at the AAO 2023 Annual Meeting.
- Patients in the OPTIC extension trial continue to experience long-term benefit from Ixo-vec through 3 years of follow-up, including maintenance of vision, durability of anatomical improvements and sustained reduction in anti-VEGF treatment burden.
- Patients at the 2E11 dose had an 84% reduction in annualized anti-VEGF injections, with 53% of the participants at the 2E11 dose receiving no supplemental injections through three years.
- Aflibercept protein levels have been sustained through follow-up, which is up to 4.5 years post-treatment.
- BCVA was maintained and CST was improved through 3 years.
- Ixo-vec was generally well tolerated with dose-dependent inflammation that was responsive to topical steroids.
LUNA Aflibercept Protein Data Highlights, Baseline Characteristics and Clinical Program Milestones
- Aflibercept protein data suggest Ixo-vec at the 2E11 and 6E10 doses deliver similar levels of aflibercept that are both within the therapeutically active range based on OPTIC and non-human primate data.
- The LUNA trial population has comparable injection frequency and other baseline characteristics, with slightly better visual acuity and fluid control, compared to the study population of OPTIC.
- In particular, the mean annualized anti-VEGF injection rate in the 12 months prior to Ixo-vec treatment in LUNA is 9.9 injections, indicating that these subjects require frequent injections, administered approximately every six weeks.
- Clinical Program Milestones:
- Q4 2023 - LUNA preliminary efficacy and safety data.
- Mid-2024 - Additional LUNA data, including the 26-week interim analysis.
“The long-term follow-up data from the OPTIC trial continue to affirm that Ixo-vec offers a potentially transformational treatment for wet AMD,” commented Carl Regillo, MD, FACS, Chief of the Retina Service at Wills Eye Hospital and presenter of the data at the AAO Annual Meeting. “A favorable benefit-risk profile resulting in an 84% reduction in annualized anti-VEGF injections was demonstrated in participants receiving the 2E11 dose, with 53% of patients continuing to be free from supplemental injections at 3 years after a single IVT injection. Taken together, the efficacy and safety at the 2E11 dose in the OPTIC trial underscore Ixo-vec's potential as a promising treatment option for wet AMD patients addressing real-world unmet needs. I look forward to learning more from the ongoing phase 2 LUNA trial.”