Sirion reports positive results from interim analysis of Phase II AMD trial

The analysis compared the growth rate of geographic atrophy (GA) lesions, as measured by retinal photography, in patients treated with daily doses of placebo or 100mg or 300mg of oral fenretinide. These data showed slower growth of the GA lesions for the 300mg dose for all lesion sizes at entry. This trend was evident as early as six months and increased over time, the company said.

Among the sub-population of 78 patients who reached the 18-month study visit, the median growth rate of the lesions in the 300mg group was 22.7% versus 41.6% in the placebo group, representing a 45% reduction in median lesion growth rate at month 18. The current study is powered to detect a 50% reduction in lesion growth rate at 24 months, noted Sirion.

Slower lesion growth was also observed in the 100mg group among subjects who had lesions smaller than the median baseline at entry. These data suggest that early intervention may improve outcomes. Based on the results of this interim analysis, Sirion plans to continue the current study to its conclusion. Sirion said that it will meet with its scientific advisors and the FDA to design an appropriate Phase III program for fenretinide.

Sirion also announced that the FDA has granted fast track designation for fenretinide for the treatment of GA associated with age-related macular degeneration (AMD).

Barry Butler, CEO of Sirion, said: “Our receipt of fast track designation has the potential to accelerate the development of fenretinide for the treatment of GA, which is a condition without a currently approved treatment. The fast track designation combined with our positive interim analysis results gives Sirion a great deal of optimism that we will be able to bring a much needed treatment option to patients with GA.”