|
 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 for 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)
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