It is estimated that almost one million people in the U.S. have been diagnosed with diabetic macular edema (DME) and that approximately 300,000 new cases develop annually. This condition is responsible for gradual distortion of acute vision, due to swelling and thickening of the part of the eye responsible for in depth central vision (macula). And while it does not lead to complete blindness, it can cause a severe loss in central vision. Ten percent of diabetic patients are at risk for developing this condition. The good news for them is that a year for now a new drug is going to be available on the market.
Currently, available treatment has many disadvantages: “The current standard of care for the treatment of DME is laser photocoagulation. Laser photocoagulation is a retinal procedure in which a laser is used to cauterize leaky blood vessels or to apply a pattern of burns to reduce edema. This procedure has undesirable side effects including partial loss of peripheral and night vision. As a result of these side effects and a desire for improved visual outcomes, retinal specialists have supplemented laser photocoagulation with non-FDA approved pharmacological therapies for the treatment of DME, including injections of corticosteroids and anti-vascular endothelial growth factor (anti-VEGF) agents. Both of these therapies are limited by a need for multiple injections to maintain a therapeutic effect,” explains Alimera Sciences.
Swiss drug manufacture Roche provides the drug named Lucentis, which is FDA approved. But these injections have serious side effects, ranging from eye infections, detached retinas, cataracts, increased eye pressure in some cases, and sometimes, although uncommonly, Lucentis patients have had serious, often fatal, problems related to blood clots, such as heart attacks or strokes.
Today Regeneron Pharmaceuticals announced that they will apply to the FDA with a new drug for diabetic macular edema this year. The medication is called Eylea and is supposed to be injected into the eye less often than other drugs. Results from two clinical trials testing Eylea in DME are encouraging, bringing good news for people with DME condition.
Sample patients were randomly given different treatment to test the drugs effect: one group received two milligrams of Eylea monthly, the second received the same amount but once every other month, and the third one had laser surgery. Both studies demonstrated similar results: patients from the first group had the best progress on reading tasks on an eye chart. They were able to read an extra 12.5 letters in the first study and 10.5 letters more on the second study, than when they started. Members of the second group were able to read an extra 10.7 letters, in both studies. And people who had surgery progressed, but they advanced only an extra 0.2 letters in the first clinical try, and 1.2 letters more than before the surgery in the second one.
To add to the good news, clinical tries revealed that the new drug is probably safer that Lucentis injections. For example, the blood-clotting and other serious problems didn’t occur more for people with diabetic macular edema who got Eylea than for those that didn’t.
Written by: Milica Zujko