Safety of aflibercept 8 mg demonstrated in pooled analysis

Aflibercept 8 mg demonstrated comparable safety to aflibercept 2 mg across the CANDELA, PHOTON, and PULSAR trials, according to data from a pooled safety analysis presented at ARVO 2023.

In the 44-week phase 2 CANDELA study, patients with treatment-naïve neovascular age-related macular degeneration (nAMD) were randomly assigned to receive 3 monthly doses of aflibercept 8 mg or 2 mg followed by doses at Weeks 20 and 32.

In the ongoing, double-masked, 96-week, non-inferiority, phase 2/3 PHOTON trial, patients with diabetic macular edema were randomized 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 to receive aflibercept 2q8, 8q12, or 8q16 after 3 monthly doses.

Safety data through week 44 in the CANDELA trial and week 48 in the PHOTON and PULSAR trials were integrated, encompassing 1773 patients (aflibercept 8 mg: n = 1217; aflibercept 2 mg: n = 556).

Treatment-emergent adverse events (TEAEs) for the aflibercept 8 mg and aflibercept 2 mg groups, respectively, are listed below:
-Ocular TEAEs: 35.2% and 35.3%
-Ocular hypertension: 0.8% and 0.4%
-Increased intraocular pressure (IOP): 2.3% and 2.3%
-Intraocular inflammation: 0.8% and 0.5%
-Serious ocular TEAEs: 1.3% and 0.7%

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%
-Retinal hemorrhage: 2.3% and 3.1%

Serious ocular TEAEs occurring in >1 patient in any treatment group were:
-Retinal detachment: 0.4% and 0%
-Increased IOP: 0.2% and 0%
-Vitreous hemorrhage: 0.2% and 0%

Reference
Schneider E. Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON, and PULSAR Trials. Presented at: ARVO 2023.