The FDA accepted for priority review the biologics license application for aflibercept 8 mg for the treatment of wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, according to a Regeneron press release.
The target action date for the review is June 27.
The application is supported by positive data from the pivotal PULSAR trial in wet AMD and PHOTON trial in DME. At 48 weeks, those treated with high-dose aflibercept in both trials met the primary endpoint of noninferiority in vision gains compared with treatment with Eylea (aflibercept (Read more...)