Eylea approved for retinopathy of prematurity treatment
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The FDA approved Eylea for the treatment of retinopathy of prematurity in preterm infants, according to a press release from Regeneron.
The approval is supported by data from the phase 3 FIREFLEYE and BUTTERFLEYE trials, which investigated Eylea 0.4 mg (aflibercept, Regeneron) vs. laser photocoagulation in 233 infants with ROP. In both trials, approximately 80% of infants treated with Eylea achieved an absence of both active ROP and unfavorable structural outcomes at 52 weeks of age, the release said.
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There were no new reported safety signals for Eylea, with ocular adverse events occurring in 39% vs. 37% of patients treated with Eylea and laser, respectively, in FIREFLEYE and 18% vs. 26%, respectively, in BUTTERFLEYE. Serious ocular adverse events occurred in 8% of patients in both groups in FIREFLEYE and 6.5% in the Eylea group vs. 11% in the laser group in BUTTERFLEYE.
“Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also the family navigating a delicate time after a preterm
birth,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, and a principal inventor of Eylea, said in the release. “For the first time, physicians will now have an FDA-approved medication in Eylea to treat this heartbreaking disease in these smallest of patients.”
Eylea, which is jointly developed by Regeneron and Bayer, is now approved to treat five retinal conditions caused by ocular angiogenesis.
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