Fewer anti-VEGF injections needed after treatment with ADVM-022 in wet AMD
Patients with neovascular age-related macular degeneration treated with ADVM-022 in the OPTIC phase 1 study have experienced a substantial reduction in annualized anti-VEGF injection frequency, according to a speaker.
“ADVM-022 is demonstrating a robust treatment response, long-term durability beyond 15 months from a single intravitreal injection and zero rescues in cohort 1, the high-dose cohort,” Carl D. Regillo, MD, FACS, said at the virtual American Academy of Ophthalmology annual meeting.
Regillo presented available data from the four cohorts in the OPTIC phase 1 study, a multicenter, open-label, dose-ranging trial assessing the safety and tolerability of a single intravitreal injection of ADVM-22 (Adverum Biotechnologies). The gene therapy candidate uses a vector capsid to deliver sustained therapeutic levels of Eylea (aflibercept, Regeneron).
Patients in cohort 1 and 4 were treated with a higher dose of ADVM-022 (6 × 1011 vg per eye) compared with cohorts 2 and 3, treated with a threefold lower dose (2 × 1011 vg per eye). Cohorts 1 and 2 included six participants each compared with nine participants in cohorts 3 and 4, Regillo said. Cohorts 1 and 2 underwent a 13-day oral course of steroids, and cohorts 3 and 4 underwent a 6-week prophylactic steroid eye drop regimen.
Before entering the trial, the participants received frequent aflibercept injections to maintain vision. Participants in cohort 1 received zero rescue injections out to 15 months, three participants in cohort 2 required one or more rescue injections by week 48, and two participants in cohort 3 have received additional injections. Rescue and efficacy data were not presented for cohort 4 due to its short follow-up, he said.
“There was good retention of vision in cohort 1 out to 72 weeks with no rescue treatments. Similar in cohort 2 was the same pattern of consistent maintenance of vision, with all patients now beyond 52 weeks. In cohort 3, with a median follow-up of 36 weeks, mean BCVA and [central subfield thickness] were stable and consistent with cohorts 1 and 2. Here, seven of nine patients remained rescue-free,” Regillo said.
The therapy has demonstrated a substantial dose-dependent reduction in annualized injection frequency and a favorable safety profile across all four cohorts with relatively low-grade inflammation well controlled with topical steroids, he said.
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Regillo CD. Intravitreal gene therapy with ADVM-022 for neovascular AMD: OPTIC phase 1 study. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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