WASHINGTON (Reuters) – The U.S. Food and Drug Administration gave the nod to a wider use for Roche Holding AG’s eye drug Lucentis, approving it for patients with diabetic macular edema.
Lucentis, made by Roche unit Genentech, is already prescribed for two other eye ailments.
The once-monthly injection is now the only FDA-approved drug specifically targeted at diabetic macular edema. But a highly promising candidate from Regeneron Pharmaceuticals Inc may be not too far behind.
In clinical trials, Lucentis helped people see at least 15 extra letters on an eye chart. People were also generally able to sustain the vision improvement for at least 24 months. But they have to continue taking the drug to maintain the benefits.
“Today’s approval represents a major development for the treatment of people whose vision is impaired by DME,” said Dr. Renata Albrecht, director of the FDA’s ophthalmology products division.
The FDA approved only the 0.3 mg dose of Lucentis, saying a higher dose that was tested showed no extra benefit in vision.
The FDA said about 34% to 45% of those treated with the 0.3 mg dose of Lucentis in clinical trials had vision improvement, compared with 12% to 18% of those getting no injection.
Common side effects included eye pain, increased pressure inside the eye, and bleeding of the conjunctiva.
Genentech said it would sell the 0.3 mg dose for $1,170, compared with the $1,950 it charges for the 0.5 mg dose used to treat other eye conditions.
Lucentis is also approved for wet age-related macular degeneration and for macular edema following retinal vein occlusion.
For macular degeneration, Lucentis has long competed with Regeneron’s drug aflibercept (Eylea) as well as with Roche’s own cancer drug Avastin (bevacizumab), which works in a similar manner but for a fraction of the price.
Avastin is not approved for eye disease. But some doctors have cut the cancer treatment into the small doses needed for an eye injection, which costs only about $50.
A U.S. government study last year found the two drugs to be similarly effective for treating macular degeneration.
However, doctors may be more hesitant to use Avastin for patients with diabetes, said Dr. David Brown, a lead investigator for the Lucentis Diabetic Macular Edema (DME) trial, and an associate clinical professor at the Methodist Hospital in Houston.
“The sense in the retina community, for whatever reason, is that Avastin doesn’t seem to work as well as Lucentis in DME,” Brown said.
Roche unit Genentech has also cautioned that Avastin increased the risk of stroke and heart attack in cancer trials, and noted that diabetics are already at much higher risk for serious heart problems.
In 2010, about 3.9 million adults diagnosed with diabetes reported trouble with their vision, the FDA said.
Diabetic macular edema has long been treated by lasers, which can slow vision loss but rarely lead to vision improvement.
Insulin is also approved for diabetic macular edema, the FDA said, as better-controlled diabetes reduces the likelihood of vision loss.