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FDA approves Eylea prefilled syringe
The FDA has approved a chemistry, manufacturing and controls prior-approval supplement for the Eylea injection prefilled syringe, Regeneron announced in a press release.
The 2-mg, single-dose, sterilized prefilled Eylea (aflibercept) syringe, which requires fewer preparation steps compared with vials, is expected to be available by the end of the year.
“With eight pivotal phase 3 trials and millions of injections used around the world, Eylea sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the release. “This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients.”