Regeneron Pharmaceuticals (NASDAQ:REGN) shares moved higher in pre-market trading after the biotechnology company reported on Friday that a higher dose of its eye disorder drug EYLEA has been approved by the Food and Drug Administration (FDA).
The FDA approved EYLEA HD (aflibercept) injection 8mg for patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).
Two late-stage clinical trials showed EYLEA HD was just as effective as its lower dose 2mg version with fewer injections required.
It is the first and only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses, Regeneron noted.
“The FDA approval of EYLEA HD is an important advancement in retinal care,” Dr. Peter Kaiser, Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and Professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine, said in a statement.
“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.”
Regeneron shares gained 1.2% to US$822.23 before the opening bell on Monday, after adding 2% at Friday’s close.
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