The Food and Drug Adminsitration, reversing itself on a decision it made in October, has opened the way for a new treatment for diabetic macular edema to reach the U.S. market.
The treatment, Iluvien, is a tiny insert implanted into the eye via a needle. It carries a drug used to treat DME, a condition that develops in many people with diabetes and can lead to blindness.
Iluvien's developers, Watertown, MA-based pSivida and Alpharetta, GA-based Alimera Sciences, had been told only three months ago by the FDA that the federal agency could not approve the companies' application "in its present form."
Concerned with what it cited as "clinical and statistical deficiencies," as well as problems with Iluvien's manufacturing facility, the FDA said that addressing those concerns might require up to a year of additional product trials and meetings with agency advisors.
The new agency ruling removed those conditions, opening the way for the companies to prepare labeling proposals that they hope to submit to the FDA by late March. That step is a final step before the agency grants marketing approval.
Iluvien is approved for use in Europe, and potential sales of the device are expected to reach $400 million. Statistics for U.S. market revenues have not been estimated.