The FDA has granted fast-track designation to Sirion Therapeutics? fenretinide for the treatment of geographic atrophy associated with age-related macular degeneration, according to the company.
-The FDA has granted fast-track designation to Sirion Therapeutics’ fenretinide for the treatment of geographic atrophy (GA) associated with age-related macular degeneration (AMD), according to the company.
“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,” said Barry Butler, chief executive officer of the company.
Fast-track designation provides Sirion with the option of submitting a new drug application (NDA) on a rolling basis, thus enabling the FDA to begin reviewing sections of the application before receiving the complete application. NDAs for products with a fast-track designation also generally receive a priority review designation, meaning the application will be reviewed in 6 months rather than the 10-month standard review time.
Sirion recently announced positive results from a planned interim analysis of its phase II trial evaluating the drug for the treatment of GA associated with AMD. The interim analysis was triggered when all patients had reached the 12-month visit.
The analysis compared the growth rate of GA lesions, as measured by retinal photography, in patients treated with daily doses of placebo or 100 mg or 300 mg of oral fenretinide. These data showed slower growth of the GA lesions with the 300-mg dose for all lesion sizes at entry, according to the company, and this trend was evident as early as 6 months and increased over time.
Among the subpopulation of 78 patients who reached the 18-month study visit, the median growth rate of the lesions in the 300-mg group was 22.7% versus 41.6% in the placebo group, representing a 45% reduction in median lesion growth rate at month 18, according to Sirion. The study is powered to detect a 50% reduction in lesion growth rate at 24 months.
Slower lesion growth also was observed in the 100-mg group among subjects who had lesions smaller than the median baseline at entry (approximately three disk areas). These data suggest that early intervention may improve outcomes, said the company.
Based on the results of this interim analysis, Sirion expects to continue the study to its conclusion. Company officials plan to meet with scientific advisers and the FDA to design a phase III trial for the drug.