Regeneron (NASDAQ: [[ticker:REGN]]) may have a whole new crop of patients for its breakout eye drug, aflibercept (Eylea), a year ahead of schedule.
The Tarrytown, NY-based biotech today announced the results of two large late-stage trials testing aflibercept in patients with diabetic macular edema, a common complication of diabetes in which blood vessels leak fluid behind the retina, distorting the vision.
Regeneron said that its drug hit the goal of the studies by improving patients’ vision, as measured by their ability to read a standard eye chart, over the course of 52 weeks. Based on the results, Regeneron now expects to file an application with the FDA to market the drug for the new indication this year—about one year sooner than it had previously anticipated. Regeneron’s partner Bayer Healthcare, which sells aflibercept in Europe, will apply for a similar approval over there as well.
In the two separate, yet similarly designed studies (one named Vista-DME, the other Vivid-DME), patients were randomly assigned either a 2 milligram injection of aflibercept once a month; the same dose once a month for five months, and then once every two months; or laser surgery. Their progress was measured after 52 weeks by the number of letters they could read on an eye chart. In the Vista study, first group read an average of 12.5 more letters more after the study ended compared to their baseline scores, while the second group read an average of 10.7 more letters. Patients who got laser surgery ultimately read an average of 0.2 more letters by the end of the study.
The numbers in the Vivid arm were similar: 10.5 more letters on average for the first group, 10.7 more letters for the second group, and 1.2 more letters for those getting laser surgery.
Regeneron said the numbers were statistically significant, meaning they weren’t likely to be due to chance. The Vista study enrolled 461 patients, while the Vivid study had a total of 404 patients, according to clinicaltrials.gov.
Regeneron said the drug was generally well tolerated, and that patients receiving it had the same number and types of ocular side effects—such as broken blood vessels in the eye, or floaters—as those who got laser surgery. Similar non eye-related side effects, such as hypertension, were seen in all groups as well.
Regeneron is tracking the patients’ progress for up to 148 weeks.
Patients with DME are currently treated with Roche’s ranibizumab (Lucentis). Roche has already been trying to fight off Regeneron’s drug in the market for the wet form of age-related macular degeneration, another condition in which blood vessels leak behind the eye, leading to distorted vision and potentially blindness. Regeneron’s drug is already approved in the U.S. to treat that condition as well as macular edema triggered by a blood clot in the vein attached to the retina, instead of diabetes. Based on today’s results, Regeneron may be able to encroach on Roche’s market share in DME sooner than expected as well.
Regeneron’s drug had $850 million in sales in 2012, its first full year on the market. Regeneron reported separately today that aflibercept generated $330 million in sales during the second quarter of 2013, roughly in line with consensus estimates from analysts, but Wall Street expected more. Regeneron’s shares slumped about 5.5 percent, to $256.01 apiece, during early trading Tuesday.
