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Fast Track Designations Given for QLT, Inc. (QLTI) Drug to Treat Two Diseases
QLT, Inc. is an ocular-focused company dedicated to the development and commercialization of novel ocular products. The company’s particular focus is on the development of drugs for the treatment of certain inherited retinal diseases.
The company today announced that its oral synthetic retinoid for retinal diseases, QLT091001, has been granted two fast track designations by the U.S. Food and Drug Administration (FDA). The first is for the treatment of Leber Congenital Amaurosis (LCA) and the second is for the treatment of autosomal recessive Retinitis Pigmentosa (RP). In both cases, the diseases are caused by inherited mutations in the LRAT and RPE65 genes.
QLT received initial FDA clearance to begin trials in July 2011. Following the recent completion of the QLT091001 Phase 1b trial for LCA treatment, QLT continues the ongoing follow-up and initial re-treatment of LCA patients. In addition, the company is targeting the completion of subject enrollment in the RP trial before the end of 2011.
The FDA’s fast track program is designed to facilitate the development and expedite the review of new drugs that are intended for the treatment of serious diseases and fill an unmet medical need. In other words, to get the needed drug to the patient as soon as possible.
For further information on QLT and its QLT091001 drug, please visit the company’s website at www.qltinc.com
