Alimera reports positive results of phase-3 study for Iluvien
ATLANTA — A drug designed to treat an eye condition caused by diabetes may provide a long-term option for patients, according to Alimera Sciences.
Alimera said in two three-year, phase-3 pivotal clinical trials — collectively known as the FAME Study — of Iluvien, which is designed to treat diabetic macular edema, the drug improved visual acuity among patients.
"This consistent response rate at month 24 and month 36, with a peak rate of 31.4% in month 30, is encouraging, and we believe demonstrates that Iluvien can provide a long-term option for the treatment of DME for up to three years," said Dan Myers, president and CEO of Alimera Sciences.
Alimera said the company will submit the data to the Food and Drug Administration, following a complete response letter it received from the agency in December 2010.