Positive Results for High-Dose Eylea From Extension Study | AAO 2024

High-dose formulations Eylea (aflibercept) that can be given less frequently continue to show good results in a 100-week extension of the study, according to results presented this weekend at the 2024 annual meeting of the American Academy of Ophthalmology in Chicago.

Spacing out the intravitreal injections of Eylea and reducing the “treatment burden” is one of the main purposes of the higher dose formulation of drug, a vascular endothelial growth factor inhibitor that the FDA has approved for neovascular (wet) age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Results from the PHOTON extension study presented at the AAO meeting by Diana V. Do, M.D., a professor of ophthalmology and vice chair for clinical affairs at Stanford University’s Byers Eye Institute, showed that 83% of those who switched from 2-milligram (mg) dose of Eylea to the larger 8-mg one were getting injections 12 weeks apart or longer at the end of the extension study.

The PHOTON study, which was designed to capture data for its primary end point at 48 weeks, with its extension, added up three years of treatment Eylea.

Do reported that there were “no new safety signals” from extension trial and no new cases of occlusive vasculitis. Treatment from Eylea is entirely not problem free. Seven (2.6%) of the 265 participants in the extension trial experienced a serious adverse event, and four (1.5%) experienced intraocular inflammation.

Data presented by Do showed a slight dip in best-corrected visual acuity (BCVA) a common end point used in ophthalmology studies, during the extension trial (from +7.8 letters to +7.7). The 70 study participants who switched from the 2-mg dose in the PHOTON to an 8-mg dose in the extension study ended up with smaller BCVA gain, on average, from baseline than 195 who were randomly assigned to the 8-mg dose in the PHOTON study and stayed on that dose during the extension (+7.2 letters compared with +7.9).

Related: FDA Approves Higher Dose Eylea

For Regeneron, the maker of Eylea, the extension study furthers the positive narrative about the high-dose version of Eylea as the original 2-mg dose faces competition from five newly approved biosimilars. Based on the results of PHOTON and PULSAR study, which tested as 8-mg dose as a treatment for wet age-related macular degeneration, the FDA approved the higher dose in August 2023.