Reuters: Regulatory News: Regeneron's Eylea improves vision in diabetic eye condition

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Regeneron's Eylea improves vision in diabetic eye condition Aug 6th 2013, 06:29 Tue Aug 6, 2013 2:29am EDT Aug 6 (Reuters) - Regeneron Pharmaceuticals Inc's Eylea helped improve the vision of patients with diabetic macular edema (DME) significantly better than laser surgery in a pair of late-stage clinical trials, paving the way for an expanded approval of the sight-saving medicine, the company said on Tuesday. Eylea is already approved to treat wet age-related macular edema, the leading cause of blindness in the elderly. The condition associated with diabetes is the leading cause of blindness in younger and middle aged adults, with potentially more than 6 million treatable patients worldwide, the U.S. biotechnology company said. As a result of the two successful trials, called Vivid-DME and Vista-DME, Regeneron said it plans to apply for U.S. approval to treat diabetic macular edema in 2013 - a year ahead of its previously projected timeline. Bayer AG, which sells the drug outside the United States, also will apply for European DME approval this year. Patients in the two year-long studies received either monthly injections of Eylea, or injections every other month following a course of five monthly injections. Eylea treatment was compared with laser photocoagulation, a type of laser surgery in which leaky blood vessels in the eye are cauterized to stop the leakage that leads to vision loss. In the Vista-DME trial, those who received monthly Eylea on average were able to see 12.5 more letters on an eye chart test after one year, than prior to receiving treatment. Those in the every other month group saw vision improve by 10.7 letters. That compared with a mean change of just 0.2 letters for the laser group. In the Vivid-DME trial the vision improvements were 10.5 letters and 10.7 letters for the Eylea monthly and less frequent dosing groups, respectively, versus an improvement of 1.2 letters for those who received laser treatment. All the results for Eylea were deemed by researchers to be highly statistically significant. Eylea was generally well tolerated in the studies with the incidence of serious adverse side effects similar across all three treatment groups, the company said. The drug was first approved in November of 2011 for wet age-related macular degeneration and received an additional approval a year later to treat macular edema following a condition known as central retinal vein occlusion. It has been grabbing market share from Roche Holding's similar Lucentis, leading Regeneron to repeatedly increase Eylea sales forecasts since its approval. The company is currently expecting 2013 Eylea sales of $1.25 billion to $1.33 billion. Link this Share this Digg this Email Reprints

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