Avacincaptad pegol shows potential in geographic atrophy secondary to AMD
In eyes with age-related macular degeneration (AMD), intravitreal administration of the complement C5 inhibitor avacincaptad pegol appears to reduce the growth of geographic atrophy (GA), according to the results of a phase II/III trial.
A total of 286 patients with GA secondary to AMD participated in the trial. The first part of the trial included 77 patients, of which 26 received avacincaptad pegol at 1 mg, 25 at 2 mg dose, and 26 the sham treatment. Meanwhile, the second part of the trial involved 209 patients, among whom 42 were given avacincaptad pegol at 2 mg, 83 at 4 mg, and 84 the sham. The patients received their treatment via intravitreal injections given once a month for a total of 18 months.
Measured by fundus autofluorescence, mean rate of GA growth (square root transformation) decreased significantly with avacincaptad pegol 2 mg (27.4 percent; p=0.0072) and 4 mg (27.8 percent; p=0.0051) than with their corresponding sham cohorts over 12 months.
The treatment effect was observed as early as month 6 and was maintained at month 12.
Safety data showed that the drug was generally well tolerated. There were no treatment-related adverse events (AEs) or inflammation documented. None of the patients developed serious ocular AEs (AEs) and endophthalmitis. The most frequent ocular AEs were related to the injection procedure.
The present data demonstrated that complement C5 inhibition slowed the progression of GA over 12 months in eyes with AMD. Because C5 inhibition is said to preserve C3 activity, it may offer additional safety advantages.