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

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Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that in the Phase 3 VISTA-DME trial of EYLEA^® (aflibercept) Injection for the treatment of diabetic macular edema (DME), EYLEA 2 milligrams (mg) dosed monthly (2Q4) and EYLEA 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 laser photocoagulation (n=154).

After two years, patients receiving EYLEA 2Q4 had a mean change from baseline in BCVA of 11.5 letters (12.5 letters at 52 weeks).  Patients receiving EYLEA 2Q8 had a mean change from baseline in BCVA of 11.1 letters (10.7 letters at 52 weeks).  Patients in the laser photocoagulation treatment group had a mean change 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 and maintained the improvement over two years in patients with diabetic macular edema," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  "These results are particularly encouraging given that 43 percent of patients in this study had previously received anti-VEGF therapy."

In this trial, EYLEA was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the EYLEA treatment groups and the laser control group.  AEs were typical of those seen in other studies in patients with diabetes receiving intravitreal anti-VEGF therapy.  The most frequent ocular AEs observed in the VISTA-DME trial included conjunctival hemorrhage, eye pain, and vitreous floaters.  The most frequent non-ocular AEs included hypertension, anemia, and urinary tract infection.  Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) were similar across the treatment groups and the laser control group with events occurring in 13 out of 155 patients in the EYLEA 2Q4 group, 11 out of 152 patients in the EYLEA 2Q8 group, and 9 out of 154 patients in the laser group.  Eight out of 155 patients died in the EYLEA 2Q4 group, 4 out of 152 patients in the EYLEA 2Q8 group, and 3 out of 154 patients in the laser treatment group.

Full two-year data from the VISTA-DME trial will be presented at upcoming medical conferences.  Two-year data from the similarly designed VIVID-DME trial are expected later in 2014.  Both the VISTA-DME and the VIVID-DME trials will continue as planned up to 148 weeks.

Posted-In: News FDA


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