FDA Expands Eylea HD Approval to Treat Macular Edema Following retinal Vein Occlusion
FORT WORTH,TX – November 21,2023 – The FDA has approved regeneron’s Eylea HD (aflibercept-vflf) for the treatment of macular edema secondary to retinal vein occlusion (RVO),expanding the therapy’s indications to address a leading cause of vision loss.The approval marks a significant advancement for patients experiencing swelling in the macula due to blocked retinal veins.
Retinal vein occlusion affects millions globally and can rapidly lead to substantial vision impairment if left untreated. Macular edema, the buildup of fluid in the central part of the retina, is a common complication of RVO. Eylea HD’s approval offers a new treatment option designed to improve visual outcomes and possibly slow disease progression for individuals impacted by this condition. The therapy builds upon the existing eylea formulation, utilizing a higher concentration of aflibercept to potentially deliver improved efficacy.
Eylea HD previously received FDA approval in August 2023 for diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following branch retinal vein occlusion (BRVO). The latest expansion now encompasses central retinal vein occlusion (CRVO) as well. Clinical trial data supporting the RVO indication demonstrated significant improvements in vision gains compared to existing therapies.
“retinal vein occlusion can have a devastating impact on a patient’s quality of life,” said Dr. charles Wykoff, a retinal specialist at Retina Consultants of Texas, in a previous statement regarding Eylea HD’s broader approvals. “Having additional treatment options, like Eylea HD, is crucial for helping patients preserve their vision.”
The FDA’s approval is based on data from the Phase 3 PANORAMA study, wich evaluated Eylea HD in patients with RVO. Further details regarding dosing and governance can be found on the FDA website and in the full prescribing details for Eylea HD.
