By Colin Kellaher
Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.
Regeneron on Thursday said the application covers Eylea HD for the treatment of macular edema following retinal vein occlusion and for broadening the dosing schedule to include monthly dosing across approved indications.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Regeneron said the FDA has set a target action date of Aug. 19 for the application after the Tarrytown, N.Y., biotechnology company used a priority-review voucher.
The company said an FDA green light would make Eylea HD the first and only treatment for retinal vein occlusion indicated for up to every-eight-week dosing after an initial monthly dosing period, halving the number of injections that are indicated for all other anti-VEGF therapies.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
April 17, 2025 07:46 ET (11:46 GMT)
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