Regeneron's EYLEA Injection Approved for Treatment of Wet Age-Related Macular Degeneration in Japan

Regeneron Pharmaceuticals REGN today announced that EYLEA (aflibercept) Injection has received approval for the treatment of patients with neovascular age-related macular degeneration (wet AMD) from the Japanese Ministry of Health, Labour and Welfare (MHLW).  In Japan, EYLEA treatment is initiated with one 2 milligram (mg) intravitreal injection per month for three consecutive months (treatment initiation).  Thereafter, in the maintenance phase, the recommended treatment is usually one intravitreal injection every two months.  The dosing interval may be adjusted according to patient response.  "The approval of EYLEA in Japan presents an important new treatment option for wet AMD patients and physicians," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "We are pleased to offer this new therapeutic option, which we hope will decrease the challenges of treatment for wet-AMD patients in Japan." The MHLW approval of EYLEA is based upon the results of two Phase 3 clinical studies (VIEW 1 and VIEW 2) which demonstrated that EYLEA dosed every other month, following three initial monthly doses was clinically equivalent to Lucentis® (ranibizumab injection) dosed every four weeks, as measured by the proportion of patients who maintained visual See full press release