Adverum Biotechnologies Reports Positive 24-Week Data from First Cohort of OPTIC Phase 1 Trial of ADVM-022 Intravitreal Gene Therapy to Treat Wet AMD
2019-09-12 · Adverum Biotechnologies, Inc. · original adverum.com ↗
— Zero anti-VEGF rescue injections required after one-time intravitreal dose of ADVM-022 — — Sustained improvements in retinal anatomy — — Was safe and well tolerated — — Data being presented during podium presentation at Retina Society 2019 Annual Meeting — — Adverum to host conference call and webcast on Thursday, September 12 at 5:30 a.m. PT / 8:30 a.m. ET / 1:30 p.m. BST — MENLO PARK, Calif. , Sept. 11, 2019 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the presentation of positive 24-week clinical data from the first cohort of patients (n=6) treated with a one-time intravitreal (IVT) dose of ADVM-022 in the OPTIC phase 1 clinical trial in wet age-related macular degeneration (wet AMD). Patients treated in this cohort achieved vision maintenance and improvements in retinal anatomy, with zero anti-VEGF rescue injections required, after a one-time intravitreal dose of ADVM-022, through week 24. These patients previously required frequent anti-VEGF injections to control their wet AMD and to maintain functional vision. ADVM-022 was safe and well tolerated. These data are being presented on Thursday, September 12, 2019 at 7:41 a.m. BST by Szilárd Kiss, M.D. during a podium presentation at the Retina Society 2019 Annual Meeting in London, UK . Adverum will host a conference call and webcast beginning at 1:30 p.m. BST ( 5:30 a.m. PT / 8:30 a.m. ET ) to review the data. Dr. Kiss’s presentation slides will be available at the conclusion of the company’s webcast presentation under the Events and Presentations in the Investors section of the company’s website located at www.adverum.com . OPTIC Phase 1 Clinical Trial 24-week Data from First Cohort (n=6) Baseline Characteristics of Patients: First Cohort Dose of intravitreal injection ADVM-022 6 x 10^11 vg/eye Mean age 79 years Mean number of years since diagnosis 3.3 years Mean number of prior anti-VEGF injections 35 injections (range 7-109) Mean number of anti-VEGF injections in 8 months prior to screening 6.2 injections Average annualized anti-VEGF injection frequency 1 9.3 injections Mean BCVA 2 study eye Approximate Snellen equivalent 65.8 letters 20/50 Mean CRT 3 study eye 369 μm 24-week Results Following One-time ADVM-022 Dose: First Cohort Rescue Injections: Number of patients requiring anti-VEGF rescue injections 0 patients Mean number of anti-VEGF rescue injections 0 injections Change in BCVA: Mean change in BCVA -2 letters Range change in BCVA -9.1 letters, +5.1 letters (90% CI) Change in CRT: Mean change in CRT -52.7 μm Range change in CRT -86.5 μm, -18.8 μm (90% CI) Safety: Serious adverse events (SAEs) 0 Dose-limiting toxicities (DLTs) 0 Systemic adverse events (AEs) potentially related to ADVM-022 0 Ocular AEs potentially related to ADVM-022 19 events in 6 patients: Mild (14) 4 Moderate (5) 4 Intermediate uveitis x2 Vitreous cells Anterior chamber cells x2
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