Regeneron Pharmaceuticals Inc. in Tarrytown recently announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every four weeks (monthly) for the first three months across all indications, followed by 8 mg every eight to 16 weeks in wAMD and DME and every eight to 12 weeks for DR.
“The FDA approval of EYLEA HD is an important advancement in retinal care,” said Peter Kaiser, M.D., Chaney Family Endowed chair in Ophthalmology Research at the Cole Eye Institute and professor of ophthalmology at Cleveland Clinic Lerner College of Medicine. “With EYLEA HD, patients with wet age-related macular degeneration or diabetic retinal disease can now receive less frequent injections after their initial monthly doses and still experience the similar visual gains, anatomic improvements and safety profile of EYLEA.”
“More than 10 years ago, we fundamentally changed the way that certain serious retinal diseases were treated with the introduction of EYLEA. With the approval of EYLEA HD, we have elevated the high standard that EYLEA set,” said George D. Yancopoulos, M.D., Ph.D., board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of EYLEA.
EYLEA HD is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD following any regulatory approvals.
