H. Russell Day, MD
Vanderbilt Eye Institute, Nashville, TN
Sunir Garg, MD from the Wills Eye Hospital presented his work on pooled safety data from the aflibercept 8 mg trials. As Dr. Garg explained, four-fold higher molar dose of aflibercept has the potential to suppress VEGF over a longer period of time. Although the safety data in each individual clinical trial were similar between 8 mg and 2 mg aflibercept, pooling the analysis from the CANDELA, PHOTON, and PULSAR trials provides a much larger set of patients to compare the rate of adverse events between the two drug doses.
A total of 1773 patients underwent treatment with 1217 receiving 8 mg and 556 receiving the 2 mg dose. The pooled analysis was carried out over a 48-week follow up period. The rate of adverse events was low and similar between the two treatment groups. Of note, the rate of increased intraocular pressure was 2.3% among both groups. Other adverse events found between the 2 mg and 8 mg aflibercept groups included cataract (2.2% vs 3.0%), conjunctival hemorrhage (2.3% vs 3.0%), vitreous floaters (2.7% vs 3.0%), reduced visual acuity (4.5% vs 2.9%), vitreous detachment (1.6% vs 2.7%), retinal hemorrhage (3.1% vs 2.3%), subretinal fluid (2.2% vs 1.3%), intraocular inflammation (0.5% vs 0.8%), and retinal detachment (0 vs 0.4%). There were no cases of endophthalmitis, vasculitis, or ischemic optic neuropathy in either treatment group.
The study also investigated rates of non-ocular adverse events such as hypertension, COVID-19 and nasopharyngitis, which were all similar between the two groups and likely non-related to the study drug. The rate of APTC including non-fatal stroke, non-fatal myocardial infarction, and vascular death were also low and similar between the doses of drug.
Overall, Dr. Garg concluded that aflibercept 8 mg had comparable safety results when compared to aflibercept 2 mg.
