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The FDA has granted orphan drug designation to verteporfin for injection (Visudyne, QLT) for the potential treatment of chronic or recurrent central serous chorioretinopathy (CSC).
Silver Spring, MD-The FDA has granted orphan drug designation to verteporfin for injection (Visudyne, QLT) for the potential treatment of chronic or recurrent central serous chorioretinopathy (CSC).
The Vancouver, British Columbia-based biotechnology company is working with external advisers on potential options for clinical studies that will assess the safety and efficacy of verteporfin in the treatment of chronic CSC and will allow the company to evaluate possible development plans.
The Orphan Drug Act allows for financial incentives to promote the development of drugs and biologics for the treatment of rare diseases or conditions that affect fewer than 200,000 patients in the United States. Incentives include a 7-year period of market exclusivity after approval for the indication, regulatory guidance, FDA fee reductions, and tax credits related to development expenses.
Verteporfin therapy is a two-step procedure. First, the drug is administered intravenously into the patient’s arm, and then it is activated via a non-thermal laser light shone into the patient’s eye. This process produces a reaction designed to close abnormal leaky vessels, resulting in a stabilization of the corresponding vision loss.
Verteporfin already is marketed worldwide for the treatment of wet age-related macular degeneration (AMD). It also is commercially available in more than 80 countries for the treatment of predominantly classic subfoveal choroidal neovascularization. In addition, more than 60 countries have approved verteporfin to treat other macular neovascular conditions such as minimally classic and occult with no classic AMD lesions, pathologic myopia, and presumed ocular histoplasmosis.
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