Alimera Sciences completes 36-month FAME study of intravitreal insert for DME

ATLANTA — The combined 3-year results of two phase 3 clinical trials support the efficacy of a steroid implant for treating diabetic macular edema, according to a press release from Alimera Sciences.

Data from the FAME (Fluocinolone acetonide in diabetic macular edema) study showed that 28.7% of patients taking Iluvien (sustained release fluocinolone acetonide, Alimera Sciences) achieved an improvement of 15 letters or more in best corrected visual acuity, compared with 18.9% of control patients.

Statistical significance was observed up to 33 months, the release said.

Last year, Alimera released 24-month FAME results that prompted the company to submit a new drug application to the U.S. Food and Drug Administration for low-dose Iluvien. Consequently, these 36-month results do not include data for patients who received the higher dose.

"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 3 years," Dan Myers, president and CEO of Alimera, said in the release.

Ken Green, PhD, chief scientific officer for Alimera, said in a conference call on Thursday that in terms of receiving fewer protocol treatments, such as anti-VEGF antibodies or vitrectomy, there is a two-to-one ratio in favor of patients taking Iluvien.

"We believe our additional data through month 36 of our trial will help the FDA evaluate the safety and efficacy of Iluvien and gain further insight into the benefit-to-risk ratio," Mr. Myers said in the conference call.

An increased IOP of 30 mm Hg or more was observed in 18.4% of patients taking Iluvien, and 4.8% of these patients underwent incisional surgery to lower pressure.

Alimera plans to announce additional data from the FAME study at the Angiogenesis, Exudation and Degeneration 2011 meeting in Miami.