Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that in the Phase 3 VIVID-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 (2 years), compared to laser photocoagulation. The 52-week results (primary analyses) from this study have been previously reported.
Patients in the VIVID-DME trial were randomized to receive either EYLEA 2Q4 (n=136), EYLEA 2Q8 (n=135), or the comparator treatment of laser photocoagulation (n=132). After two years, patients receiving EYLEA 2Q4 had a mean change from baseline in BCVA of 11.4 letters (10.5 letters at 52 weeks, P less than 0.0001 vs. laser). Patients receiving EYLEA 2Q8 had a mean change from baseline in BCVA of 9.4 letters (10.7 letters at 52 weeks, P less than 0.0001 vs. laser). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.7 letters (1.2 letters at 52 weeks). Additionally, 31.1 percent of patients receiving EYLEA 2Q8 achieved an increase of greater than or equal to 15 letters, or approximately 3 lines of vision, from baseline (P = 0.0001), and 38.2 percent receiving EYLEA 2Q4 achieved an increase of greater than or equal to 15 letters from baseline (P less than 0.0001 vs. laser), compared with 12.1 percent of patients in the laser control arm achieving similar vision gains.
"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.
In this trial, EYLEA had 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. The most frequent ocular AEs observed in the VIVID-DME trial included conjunctival hemorrhage, cataract, and increased intraocular pressure. The most frequent non-ocular AEs included nasopharyngitis and hypertension. 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 8 out of 136 patients in the EYLEA 2Q4 group, 5 out of 135 patients in the EYLEA 2Q8 group, and 3 out of 133 patients in the laser group. Four out of 136 patients died in the EYLEA 2Q4 group, 6 out of 135 patients in the EYLEA 2Q8 group, and 1 out of 133 patients in the laser treatment group.
Full two-year data from the VIVID-DME trial will be presented at upcoming medical conferences. Both the VIVID-DME and VISTA-DME trials will continue as planned up to 148 weeks.
EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO. In Europe, the CHMP has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, Latin America, and the U.S., for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). A regulatory submission has been made in the U.S. and Europe for EYLEA for the treatment of macular edema following Branch Retinal Vein Occlusion (BRVO).
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage on net sales.
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