Avacincaptad Pegol for GA
Ophthalmology, April 2021
Jaffe et al. conducted a phase 2/3 pivotal study of the safety and efficacy of intravitreal avacincaptad pegol for geographic atrophy (GA) associated with age-related macular degeneration (AMD). They found that 2- and 4-mg dosing regimens of the drug slowed GA progression significantly in comparison to sham treatment. Moreover, the safety profiles were favorable.
For this two-part study, the researchers included 286 patients with GA secondary to AMD (mean age, 78.2 years). The main efficacy measure was mean rate of change in GA, determined from fundus autofluorescence imaging at baseline and months 6 and 12 of treatment. Injections were administered monthly. In part 1 of the study, 77 patients were assigned randomly (1:1:1) to one of three groups: avacincaptad pegol 1 mg, avacincaptad pegol 2 mg, or sham control. Part 2 consisted of 209 patients randomized (1:2:2) to receive avacincaptad pegol 2 mg, avacincaptad pegol 4 mg, or sham. Due to the drug’s viscosity, the 4-mg dose was divided into two intravitreal injections of 2 mg. For uniformity, the avacincaptad pegol 2-mg group also received a sham administration during each treatment, and the sham group was given two sham injections.
Both the 2-mg and 4-mg doses of avacincaptad pegol met the primary efficacy end point. GA growth (by square-root transformation) through month 12 was 27.4% (p = .0072) and 27.8% (p = .0051), respectively, compared with growth in the sham groups. Avacincaptad pegol was well tolerated overall; there were no drug-related adverse events (AEs) or serious ocular AEs.
A phase 3 confirmatory trial is underway. Given the similar efficacy of the 2- and 4-mg regimens, and the need for just one injection with 2-mg treatment, the higher dose was excluded from the phase 3 trial.
The original article can be found here.