UPDATE: Regeneron Reports Two-Year Results from Phase 3 VISTA Trail of Eylea, Says Showed Sustained Improvement in Vision

Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) and Bayer HealthCare today announced that in the Phase 3VISTA-DME trial of EYLEA^® (aflibercept) Injection for the treatment ofdiabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly (2Q4) andEYLEA 2 mg dosed every two months (after 5 initial monthly injections, 2Q8)showed a sustained improvement from baseline in best corrected visual acuity(BCVA) at week 100, compared to laser photocoagulation.  The 52-week results(primary analyses) from this study have been previously reported.  Patients in the VISTA-DME trial were randomized to receive either EYLEA 2Q4(n=155), EYLEA 2Q8 (n=152), or the comparator treatment of laserphotocoagulation (n=154).After two years, patients receiving EYLEA 2Q4 had a mean change from baselinein BCVA of 11.5 letters (12.5 letters at 52 weeks).  Patients receiving EYLEA2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at52 weeks).  Patients in the laser photocoagulation treatment group had a meanchange from baseline in BCVA of 0.9 letters (0.2 letters at 52 weeks)."These data showed that treatment with EYLEA in this trial improved vision andmaintained the improvement over two years in patients with diabetic macularedema," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer ofRegeneron and President of Regeneron Laboratories.  "These results areparticularly encouraging given that 43 percent of patients in this study hadpreviously received anti-VEGF therapy."In this trial, EYLEA was generally well tolerated with a similar overallincidence of adverse events (AEs), ocular serious AEs, and non-ocular seriousAEs across the EYLEA treatment groups and the laser control group.  AEs weretypical of those seen in other studies in patients with diabetes receivingintravitreal anti-VEGF therapy.  The most frequent ocular AEs observed in theVISTA-DME trial included conjunctival hemorrhage, eye pain, and vitreousfloaters.  The most frequent non-ocular AEs included hypertension, anemia, andurinary tract infection.  Arterial thromboembolic events as defined by theAnti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardialinfarction, and vascular death) were similar across the treatment groups andthe laser control group with events occurring in 13 out of 155 patients in theEYLEA 2Q4 group, 11 out of 152 patients in the EYLEA 2Q8 group, and 9 out of154 patients in the laser group.  Eight out of 155 patients died in the EYLEA2Q4 group, 4 out of 152 patients in the EYLEA 2Q8 group, and 3 out of 154patients in the laser treatment group.Full two-year data from the VISTA-DME trial will be presented at upcomingmedical conferences.  Two-year data from the similarly designed VIVID-DMEtrial are expected later in 2014.  Both the VISTA-DME and the VIVID-DME trialswill continue as planned up to 148 weeks.