Abstract
Purpose :
To compare the safety of aflibercept 8 mg and 2 mg in the CANDELA, PHOTON, and PULSAR trials.
Methods :
CANDELA was a single-masked, open-label, 44-week, phase 2 trial in which treatment-naïve patients with neovascular age-related macular degeneration (nAMD) were randomized 1:1 to receive 3 monthly doses of aflibercept 8 mg or 2 mg followed by doses at Weeks 20 and 32. PHOTON is an ongoing, double-masked, 96-week, non-inferiority, phase 2/3 trial that randomized patients with diabetic macular edema 1:2:1 to receive aflibercept 2 mg every 8 weeks after 5 monthly doses (2q8) or aflibercept 8 mg every 12 or 16 weeks after 3 monthly doses (8q12 or 8q16). In the ongoing, double-masked, 96-week, non-inferiority, phase 3 PULSAR trial, patients with nAMD were randomized 1:1:1 to receive aflibercept 2q8, 8q12, or 8q16 after 3 monthly doses. Safety data were integrated across all 3 trials through Week 44 (CANDELA) and 48 (PHOTON and PULSAR).
Results :
Overall, 1773 patients (aflibercept 8 mg: n=1217; aflibercept 2 mg: n=556) were treated and evaluated. Ocular treatment-emergent adverse events (TEAEs) in the study eye were reported in 35.2% and 35.3% of patients who received aflibercept 8 mg and 2 mg, respectively. The most common ocular TEAEs were reduced visual acuity (2.9% and 4.5%), vitreous floaters (3.0% and 2.7%), cataract (3.0% and 2.2%), conjunctival hemorrhage (3.0% and 2.3%), and retinal hemorrhage (2.3% and 3.1%) with aflibercept 8 mg and 2 mg, respectively. Ocular hypertension was reported in 0.8% and 0.4% of patients with aflibercept 8 mg and 2 mg, respectively, and increased intraocular pressure (IOP) was reported in 2.3% of patients in each group. Intraocular inflammation was experienced in 0.8% and 0.5% of aflibercept 8 mg- and 2 mg-treated patients, respectively. Serious ocular TEAEs were reported in 1.3% of aflibercept 8 mg-treated patients and 0.7% of aflibercept 2 mg-treated patients. Serious ocular TEAEs occurring in >1 patient in any treatment group were retinal detachment (0.4% and 0%), increased IOP (0.2% and 0%), and vitreous hemorrhage (0.2% and 0%). There were no cases of endophthalmitis or occlusive retinal vasculitis. Adjudicated APTC events were reported in 1.5% and 2.0% of patients with aflibercept 8 mg and 2 mg, respectively.
Conclusions :
Aflibercept 8 mg demonstrated comparable safety to aflibercept 2 mg across the CANDELA, PHOTON, and PULSAR trials.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.