Abicipar for Neovascular AMD: Two-Year Results
By Lynda Seminara
Selected By: Stephen D. McLeod, MD
Journal Highlights
Ophthalmology, July 2021
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Khurana et al. pooled two-year data for the CEDAR and SEQUOIA trials and found that abicipar was effective when given every eight or 12 weeks (Q8 or Q12) for neovascular age-related macular degeneration (AMD). This longer duration of effect, when compared to ranibizumab, translates to fewer overall injections and lower costs for patients with neovascular AMD. However, a higher incidence of intraocular inflammation was noted in abicipar-treated eyes than in those that received ranibizumab.
The CEDAR and SEQUOIA trials were designed to test whether abicipar is noninferior to ranibizumab through 52 weeks in patients with active choroidal neovascularization secondary to AMD. One eye per patient was enrolled; best-corrected visual acuity (BCVA) ranged from 24 to 73 ETDRS letters. Favorable results led to treatment continuity through week 104 to determine if the benefits persisted for another year. In year 2, each patient received four or six injections of abicipar or 11 injections of ranibizumab. Efficacy measures included stable vision (a loss of <15 letters from initial baseline values) and changes in central retinal thickness (CRT). Adverse events were recorded to assess safety.
The final analysis set included 443 patients on abicipar Q8, 442 on abicipar Q12, and 520 on ranibizumab Q4. At week 104, vision was stable in 93.0%, 89.8%, and 94.4% of those in each cohort, respectively. Mean BCVA gains from baseline were 7.8, 6.1, and 8.5 letters, respectively. Mean CRT reductions from baseline were 147 μm, 146 μm, and 142 μm, respectively.
With regard to intraocular inflammation, the overall incidence of inflammation from baseline through week 52 was 15.4% for the abicipar Q8 patients, 15.3% for those who received abicipar Q12, and 0.3% of those who received ranibizumab Q4. From baseline through week 104, those percentages were 16.2%, 17.6%, and 1.3%, respectively. The overall percentage of enrolled patients who completed the two-year study was 70.8% for the abicipar Q8 cohort, 70.7% for those who received abicipar Q12, and 82.7% for those who received ranibizumab Q4.
The original article can be found here.