On Air Now

Listen

Listen Live Now » 99.9 FM Fargo-Moorhead

Weather

Current Conditions(Fargo,ND 58103)

More Weather »
83° Feels Like: 83°
Wind: NNW 9 mph Past 24 hrs - Precip: 0”
Current Radar for Zip

Today

Sunny 82°

Tonight

Mostly Clear 58°

Tomorrow

Sunny 85°

Alerts

Alimera makes fourth bid for eye treatment approval from FDA

(Reuters) - Alimera Sciences Inc said it has applied a fourth time for U.S. regulatory approval to start selling an eye implant that delivers a drug to treat a form of blindess in diabetes patients.

Alimera said it had provided a safety update and responded to questions the U.S. Food and Drug Administration raised in October, when it rejected marketing approval fo the treatment for a third time.

The FDA asked for a new trial of the drug-device combination, but Alimera's partner, Psivida Corp, said that additional trials were not necessary.

The eye implant, Iluvien, is intended to treat blindness associated with diabetic macular edema (DME), a condition that causes a patient's eye to swell, cutting their sight.

The treatment is already approved in some European countries, including the United Kingdom, Austria, Portugal and Germany.

(Reporting By Vrinda Manocha in Bangalore; Editing by Rodney Joyce)

Comments