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news.Canada based QLT's Visudyne (verteporfin for injection) has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of chronic or recurrent central serous chorioretinopathy (CSC).
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Visudyne therapy is a two-step procedure where initially the drug is intravenously administered into the patient’s arm and then a non-thermal laser light is passed into the patient’s eye to activate the drug.
The orphan drug status enables financial incentives to promote the development of drugs and biologics for the treatment of rare diseases or conditions.
The company is currently investigating the safety and efficacy of Visudyne in the treatment of chronic CSC which will allow QLT to evaluate possible development plans.
CSC symptoms include reduced visual acuity (VA), scotomas, or blind spots in the central visual field, reduced contrast sensitivity and color vision.