TARRYTOWN, N.Y. — The U.S. Food and Drug Administration's
Dermatologic and Ophthalmic Drugs Advisory Committee has recommended approval
of Eylea for the treatment of
wet age-related macular degeneration, according to a news
FDA made its recommendation on June 17.
The regimen under review is 2 mg of Eylea, also known as
VEGF Trap-Eye (aflibercept ophthalmic solution, Regeneron
Pharmaceuticals) every 8 weeks following three initial doses every 4 weeks,
according to the release.
"The positive recommendation by the advisory committee is an important
step toward providing wet AMD patients with a new treatment option that could
potentially reduce the burden that exists with current therapies," George D.
Yancopoulos, MD, PhD, president of Regeneron Research Laboratories, said in the
release. "We look forward to continuing to work with the FDA as it completes
its evaluation of the Eylea [Biologics License Application]."
The committee based its recommendation on results of two phase 3
clinical trials, VIEW 1 and VIEW 2. According to the release, all regimens of
aflibercept ophthalmic solution met the primary endpoint of statistical
Genentech) 0.5 mg monthly dosing, the current standard of
care. The drug maintained or improved vision over 52 weeks at a rate comparable
to ranibizumab, the release said.
In addition, aflibercept ophthalmic solution offered a safety profile
comparable to ranibizumab; the most common ocular adverse events were
conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage and
The FDA will consider the recommendation of approval and Regeneron's
Biologics License Application; the recommendation is non-binding. Regeneron's
application received Priority Review designation in February; the FDA is
expected to render a decision on the application by Aug. 20.
Regeneron holds exclusive U.S. rights to aflibercept ophthalmic
Bayer HealthCare will market the drug outside the U.S., and
the companies will equally share the profits from sales outside the U.S., the