On September 16, 2014, the U.S. Food and Drug Administration granted Eylea (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The drug is expected to help enhance vision among diabetics living with the eye disorder.
DME is a fairly common diabetes complication. In fact, the eye disorder is the leading cause of vision loss among working-age adults in the U.S. But now, those living with Type 1 or Type 2 diabetes might soon have a new treatment option that may improve their vision.
"Millions of people in the U.S. are living with diabetic eye diseases that can cause vision loss and even blindness," Dr. George Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in a statement. "There are no FDA-approved medicines for diabetic retinopathy and we look forward to working closely with the FDA to potentially bring Eylea to these patients as soon as possible. We plan to submit a supplemental Biologics License Application in the U.S. for diabetic retinoapthy in patients with DME later this year."
Diabetic retinopathy causes damage to the retina, which may lead to poor vision and even vision loss. Over time, patients with diabetic retinopathy face a risk of vision-threatening events, including DME, which refers to the swelling of the macula, the part of the retina responsible for central, fine vision.
It is estimated that of the 29.1 million American adults living with diabetes, 7.7 million have diabetic retinopathy and 1.5 million have been diagnosed with DME, according to the National Institutes of Health.
What is the drug?
Eylea is essentially an eye injection designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability). In clinical trials, separate groups of patients took a 2-milligram dosage either monthly or every eight weeks following five initial monthly injections.
What qualifies as 'breakthrough' label?
The Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions. To qualify, drugs must show credible evidence of significant improvement in clinical studies.
For Eylea, the designation was based on promising results in two Phase 3 trials where Eylea demonstrated a statistically significant improvement in a pre-specified measure of diabetic retinopathy in patients with DME after two years of treatment.
In the treatment, diabetic retinopathy patients with DME received five initial monthly injections. Afterward, 29 percent of evaluable patients in one group and 33 percent of evaluable patients in the second group treated with Eylea saw at least a two-step improvement on the diabetic retinopathy severity scale (DRSS) - a grading system measuring the degree of retinopathy - compared to 8 percent of patients in the laser control group.
Eylea is approved in the U.S., Europe and other countries for the treatment of DME, wet age-related macular degeneration and macular edema following central retinal vein occlusion.
In addition to glucose monitoring, this treatment may serve as a helpful tool for diabetic patients to prevent diabetes complications.