Adverum Biotechnologies, Inc. announced new analyses from the OPTIC study treating wet age-related macular degeneration (wet AMD) during the Late Breaking Developments portion of Retinal Subspecialty Day at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting in Chicago, Illinois. New data presented include the effects of ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022) on control of IRF and SRF after a single, in-office, intravitreal (IVT) injection in subjects requiring frequent anti-VEGF injections for their wet AMD. Data Highlights: Following a single IVT injection of a 2E11 dose of Ixo-vec in OPTIC (n=15), there was a 93% and 55% reduction in mean IRF and SRF volume, respectively, from baseline to Week 48.

The percentage of subjects with dry SRF, across both the 6E11 and 2E11 dose groups, increased through Week 48 with a 200% increase in the 2E11 dose group (n=15). Importantly, 60% of OPTIC participants receiving the 2E11 dose had dry IRF at Week 48, representing a 50% increase from baseline. Patient enrollment and dosing are currently underway in LUNA, a double-masked, randomized, Phase 2 trial.

Adverum expects to conduct the trial at approximately 40 sites in the U.S. and Europe. LUNA will evaluate Ixo-vec in subjects with wet AMD who are 50 years or older and have demonstrated a response to anti-VEGF treatment. Up to 72 subjects will be randomized equally between the 2E11 dose and new lower 6E10 dose and across four prophylactic steroid regimens.

Specific regimens being evaluated include topical difluprednate (Durezol®), IVT dexamethasone (Ozurdex®), or a combination of either topical Durezol® or IVT Ozurdex® with oral prednisone, with the aim of establishing a prophylactic regimen with minimal need for inflammation management post prophylaxis.