An experimental drug by Eli Lilly and Co. showed promise in reducing vision loss caused by the effects of diabetes on the retina, according to combined data from a pair of late-stage clinical trials presented on Sunday.
The drug, ruboxistaurin, which is expected to be sold under the brand name Arxxant if approved, reduced the risk of moderate vision loss by 41 percent, compared with a placebo, the study’s investigators said at the American Diabetes Association scientific meeting in Washington.
“It’s a completely new approach that can help slow down loss of vision,” Dr. Lloyd Paul Aiello, the study’s lead investigator, said in an interview.
“Many people fear blindness more than death and this gives another chance to prevent or delay blindness from the disease,” Aiello added.
If approved, Arxxant could be the first pill to cut the risk of vision loss caused by diabetic retinopathy. Currently, laser treatments are used to treat the disease, which is common among diabetics.
In early stages of diabetic retinopathy, blood vessels in the retina can leak, harming vision. In the more severe, proliferative stage, a profusion of fragile new blood vessels form in the back of the eye that are especially prone to such leaking, further damaging vision.
According to the data, vision loss occurred in 6.1 percent of patients treated with the Lilly drug, compared with 10.2 percent in those who received a placebo, researchers said. Vision loss was defined as a three-line loss on an eye chart test sustained for at least six months.
While the drug helped reduce vision loss in patients with nonproliferative diabetic retinopathy, it did not prevent progression of the disease to the more serious proliferative stage.
One of the two studies considered in the combined data had a primary goal of preventing progression to the proliferative stage.
However, a Lilly spokeswoman said the U.S. Food and Drug Administration had agreed to review the pooled data in deciding on whether to approve the drug, widely considered to be one of the most important in the company’s development pipeline.
The two studies, carried out over three years, involved 813 patients who received either 32 milligrams of ruboxistaurin or a placebo.
Aiello did not see the drug’s failure to prevent progression to proliferation as a major stumbling block to approval.
“Vision is the main concern and the drug seems to work at the earlier stage of the disease in preventing vision loss,” he said.