U.S. health advisers back two new eye treatments
WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel on Thursday recommended two drugs for combating different forms of vision loss that can lead to blindness among a range of adults, including diabetics and the elderly.
The FDA advisory committee of outside experts gave its support to Swiss-based Roche Holding AG's Lucentis eye drug for treatment of diabetic macular edema and Belgium-based ThromboGenics' treatment for viteromacular adhesion, a condition that often develops with aging.
The recommendations will now be considered by FDA regulators as they decide whether to approve the two injectable drugs for sale in the United States.
The news emerged after the companies' shares had ended trading in Europe. Roche shares closed slightly higher at 168 Swiss francs, while ThromboGenics fell 4.82 percent to 23.30 euros.
The panel gave its blessing to both 0.3 milligram and 0.5 milligram doses of Roche's drug, known generically as ranibizumab, after reviewing clinical research showing it clearly helps diabetic patients who suffer from diabetic macular edema, or DME.
However, some panel members expressed concern about evidence linking higher doses of the drug to adverse events, including death.
Lucentis, which is made by Roche unit Genentech and administered by monthly injection, is already approved for two other eye ailments.
"The committee's recommendation is an important step towards improving the care of Americans with diabetic macular edema. If approved by the FDA, this will be the first major development for treating diabetic macular edema in more than 25 years," Genentech said in a statement.
The leading cause of vision loss among diabetics, DME occurs when leaking blood vessels in the eye cause swelling at the center of the retina. The result is a progressive blurring of images near the center of a patient's field of vision, and sometimes blindness.
About 75,000 new cases of DME are estimated to develop among Americans each year. Genentech says that about 560,000 in total are affected by the disease.
There are currently no FDA-approved drugs for DME. The condition is currently treated by laser surgery to stop blood vessels from leaking. The treatment can slow vision loss, but it rarely leads to vision improvement.
Lucentis is already approved to treat wet age-related macular degeneration - the leading cause of blindness among the elderly. It is also approved for macular edema following retinal vein occlusion (RVO), a swelling or thickening of the part of the retina responsible for central vision.
If approved for DME, Lucentis will likely compete with a highly promising drug being tested by Regeneron Pharmaceuticals Inc and Roche's own cancer drug, Avastin, which works in a similar manner as Lucentis.
Regeneron shares closed 5.3 percent higher at $135.64 on Nasdaq following the advisory panel's decision.
The same FDA committee later concluded that ThromboGenics' injectable drug, known generically as ocriplasmin, helped enough people in clinical trials to warrant a favorable review, despite evidence of adverse effects, including eye pain, swelling and blurred vision.
Several panel members recommended further studies to monitor safety and determine more fully the drug's effectiveness.
Vitreomacular adhesion often results from aging and can lead to visual impairment or blindness. But it currently can be treated only through surgery.
It occurs when vitreous gel detaches at the back of the eye but adheres to the retina as it pulls away, distorting vision and causing small breaks to develop in the macula, a portion of the retina that is important for central vision.
Ocriplasmin is ThromboGenics' main drug. The company has secured a deal to sell ocriplasmin in 40 countries outside the United States through Novartis AG's opthalmic division, Alcon.
ThromboGenics plans to market the product itself within the United States.