Published June 17, 2011
A new eye medicine from Regeneron Pharmaceuticals and Bayer AG was a safe and effective way of treating vision loss from macular degeneration, a U.S. advisory panel unanimously said on Friday.
The advisers to the Food and Drug Administration also said the drug, to be marketed as Eylea, could be dosed once every two months, giving it an edge over the typical monthly dosing of its chief competitor, Lucentis, from Roche Holding .
``The data is very compelling for equivalence (with Lucentis),'' said Dr. Lynn Gordon, a panel member and associate professor in the department of ophthalmology at the University of California in Los Angeles.
The FDA usually approves medicines that win advisory panel backing and is expected to rule on Eylea by Aug. 20. The panel voted 10-0 in favor of the medicine.
The drug, also known as VEGF Trap-Eye, uses a mechanism similar to the one employed by Lucentis to preserve vision in patients with the wet form of age-related macular degeneration (AMD) -- the leading cause of blindness in the elderly.
Some 13 million Americans have signs of AMD and more than 1 million Americans have the wet form, the most severe type.
Both Lucentis and Eylea may face competition from Roche's cancer drug Avastin, a much less expensive medicine that is often used by doctors to treat macular degeneration even though it has not been approved by the FDA for that purpose.
Piper Jaffray analyst Edward Tenthoff sees Regeneron taking 25 percent of the U.S. market by 2016, with sales of $1.2 billion.
Regeneron shares were halted on Nasdaq pending the panel's recommendation. (Reporting by Anna Yukhananov; Editing by Tim Dobbyn)