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FAME trial meets primary endpoint at 36 months
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 Peter A. Campochiaro |
ORLANDO, Fla. — At 36 months, the conclusion of the phase 3 clinical trial, the FAME study met its primary endpoint of mean change in BCVA in patients with diabetic macular edema, a physician reported here.
"A statistically significant number of patients gained 3 or more lines, which was maintained out to 36 months," Peter A. Campochiaro, MD, said of the Fluocinolone acetonide in diabetic macular edema (FAME) trial at Retina Subspecialty Day that preceded the annual meeting of the American Academy of Ophthalmology.
"We now have pharmacokinetic data that demonstrate that the 0.2 µg daily dose [of fluocinolone acetonide delivered via the sustained-delivery device (Iluvien, Alimera Sciences)] yields a constant level, out to 3 years. The 0.5 µg daily dose provides sustained delivery for 2 years," he said.
Dr. Campochiaro addressed the need for IOP-lowering therapy consequent to treatment, saying that 62% of patients treated with Iluvien did not require IOP-lowering medication and less than 5% of Iluvien-treated patients required IOP-lowering surgery over the 3 years.
"[The study] also demonstrated that there is a subgroup who have DME for 3 or more years who have double the benefit from Iluvien," he said.
- Disclosure: Dr. Campochiaro is a speaker for Alimera Sciences.