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
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
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
About Wet Age-Related Macular Degeneration
Wet AMD, also known as neovascular AMD or nAMD, is a VEGF driven advanced form of AMD affecting approximately 10% of patients living with AMD associated with the build-up of fluid in the macula and the retina. Wet AMD is a leading cause of blindness in people over 65 years of age, with approximately 20 million individuals worldwide living with this condition. New cases of wet AMD are expected to grow significantly worldwide as populations age. AMD is expected to impact 288 million people worldwide by 2040, with wet AMD accounting for approximately 10% of those cases. Additionally, wet AMD is a bilateral disease, and incidence of nAMD in the second eye is up to 42% in the first 2 to 3 years. The current standard of care requires frequent life-long repeated bolus injections of anti-VEGF in the eye. IVT gene therapy has the promise to preserve vision and reduce most or all injections for the life of the patient by delivering stable therapeutic levels of anti-VEGF to control macular fluid.
About Ixo-vec in Wet AMD
Adverum is developing ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), its clinical-stage gene therapy product candidate, for the treatment of wet AMD. Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require surgery to administer the gene therapy under the retina (sub-retinal approach), Ixo-vec is designed to be administered as a one-time IVT injection in the physician's office, deliver long-term efficacy, reduce the burden of frequent anti-vascular endothelial growth factor (VEGF) injections, optimize patient compliance and improve vision outcomes for patients with wet AMD. In recognition of the need for new treatment options for wet AMD, the
About
Forward-looking Statements
Statements contained in this press release regarding events or results that may occur in the future are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding the potential benefits of Ixo-vec in the treatment of wet AMD, the design of and enrollment in the LUNA trial, including the prophylactic corticosteroid regimens, and anticipated preliminary and interim data from the LUNA trial. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the timing of commencement and completion of clinical trials; regulatory uncertainties; enrollment uncertainties; the results of early clinical trials not always being predictive of future clinical trials and results and the potential for future complications or side effects in connection with use of Ixo-vec. Additional risks and uncertainties facing Adverum are set forth under the caption 'Risk Factors' and elsewhere in Adverum's
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