The FDA has accepted for review Regeneron Pharmaceuticals’ supplemental Biologics License Application of aflibercept (EYLEA Injection) to treat diabetic retinopathy.
The FDA has accepted for review Regeneron Pharmaceuticals’ supplemental Biologics License Application (sBLA) of aflibercept (EYLEA Injection) to treat diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes.
The agency is expected to make a decision on the application in the spring.
The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe nonproliferative diabetic retinopathy without diabetic macular edema (DME), according to Regeneron.
Positive 6-month topline results from PANORAMA were previously announced, and 1-year results from the study are expected to be shared this year.
The efficacy and safety of the potential use of EYLEA in DR without DME has not been fully evaluated by any regulatory authority.
EYLEA is administered as a 2-mg intravitreal injection and is indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and DR in patients with DME.
Aflibercept is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in the medication.
FDA to review EYLEA (aflibercept) injection for the treatment of diabetic retinopathy [news release]. Tarrytown, NY; September 13, 2018: Regeneron Pharmaceuticals Inc. prnmedia.prnewswire.com/news-releases/fda-to-review-eylea-aflibercept-injection-for-the-treatment-of-diabetic-retinopathy-300711748.html. Accessed September 13, 2018.