Kunimoto D, Yoon YH, Wykoff CC, Chang A, Khurana RN, Maturi RK, Agostini H, Souied E, Chow DR, Lotery AJ, Ohji M. Efficacy and Safety of Abicipar in Neovascular Age‐Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study. Ophthalmology. 2020 Apr 9.
To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis.
The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was −144, −145, and −144 μm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids.
Visual acuity on presentation included light perception (LP) in 18 eyes (29%) and hand motion (HM) in 23 eyes (37%). Initial treatment was maximum possible vitrectomy in 48 eyes (77%) and tap-and-inject in 14 eyes (23%), with 38 eyes (61%) receiving two or more treatments. Cultures for the first intervention were positive in 49 eyes (79%) and virulent in 18 eyes (29%). At a median follow-up time of five months, final visual acuity was ≥20/40 in 49 eyes (79%), between 20/50 and 5/200 in seven eyes (11%), and <5/200 in six eyes (10%). Virulence was the strongest predictor of poor visual outcome. Retinal detachment occurred in four eyes (6%), likely from necrotic retinal defects in each case.
Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.