WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) announced that in the Phase 3 VIVID-DME trial of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema or 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 or BCVA at week 100 (2 years), compared to laser photocoagulation.
In this trial, EYLEA had a similar overall incidence of adverse events or 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.
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 or AMD in November 2011 and for Macular Edema following Central Retinal Vein Occlusion or 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.
Diabetic Macular Edema is a common complication of Diabetic Retinopathy (DR), a disease affecting the blood vessels of the retina. Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
Diabetic Macular Edema is the most frequent cause of blindness in young and mid-aged adults.
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