Intravitreal pegcetacoplan well tolerated in patients with geographic atrophy
Administering intravitreal pegcetacoplan monthly or every other month in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) is well tolerated at 12 months, according to safety data presented for the first time at ASRS 2022.
The phase 3 OAKS and DERBY trials evaluated the efficacy and safety of pegcetacoplan. Across both trials, 6322 pegcetacoplan injections were given (safety set: OAKS, n = 636; DERBY, n = 620).
AEs in the study eye considered related to treatment were reported in 6.6% (OAKS) and 9.2% (DERBY) of patients in the monthly (PM) treatment group; 7.5% (OAKS) and 6.3% (DERBY) in the every-other-month (PEOM) treatment group, and 3.8% (OAKS) and 2.9% (DERBY) in the sham group. Serious ocular AEs in the study eye were reported in 1.4%, 1.9%, and 0 patients in OAKS; and 0.5%, 0, and 1% patients in DERBY in the PM, PEOM, and sham arms, respectively.
In OAKS, 1 patient in the PM group, 2 in the PEOM group, and 1 in the sham group discontinued treatment due to ocular AEs in the study eye; in DERBY, 1 patient in the PEOM group and 2 patients in the sham group discontinued treatment.
Investigator-reported events of new onset exudative AMD (eAMD) in the study eye in OAKS and DERBY were reported 6% in the PM arm, 4.1% in the PEOM arm, and 2.4% in the sham arm.
Intraocular inflammation (IOI) was reported in 13 eyes receiving pegcetacoplan with 10 of the patients continuing treatment with pegcetacoplan without IOI recurrence. The rate of IOI per injection was 0.22%.
AEs related to intraocular pressure in the study eye were reported in 3.8%, 4.7%, and 0.5% patients in the PM, PEOM, and sham arms of OAKS and 3.4%, 3.4%, and 0 patients, respectively, in DERBY.
Baumal C. Safety of Intravitreal Pegcetacoplan for Geographic Atrophy: 12-Month Results of the OAKS and DERBY Trials. Presented at: ASRS 2022.