Regeneron Pharmaceuticals Inc's Eylea significantly improved vision in patients with diabetic macular edema (DME) compared to laser surgery in two late-stage clinical trials, paving the way for an expanded approval of the sight-saving medicine, the company said on Tuesday.
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.
Eylea is already approved to treat wet age-related macular edema, the leading cause of blindness in the elderly.
The company also reported a higher second-quarter profit that missed Wall Street estimates as the growth in Eylea sales slowed as existing patients moved to a less frequent dosing.
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 this year for European approval to treat DME.
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 compared to before 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 improvement was 10.5 letters for the Eylea monthly and 10.7 letters for less-frequent dosing groups, versus 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.
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