QLT Inc., a biotechnology company, is engaged in the development and commercialization of ocular products that address the unmet medical needs of patients and clinicians worldwide. QLT091001 – Synthetic Retinoid Program The company develops QLT091001, a synthetic retinoid compound for the potential treatment of certain age-related and inherited retinal degenerative diseases. The company is in the process of evaluating QLT091001 for the treatment of Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). In 2013, the company met with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including an end-of-phase II meeting with the FDA, with a goal to progress QLT091001 for the treatment of certain inherited retinal diseases into pivotal trials in 2014. In 2011, the United States Patent and Trademark Office issued Patent No. 7,951,841, a key patent related to this program, covering various methods of use of QLT091001 in the treatment of diseases associated with an endogenous 11-cis-retinal deficiency, expiring on July 27, 2027, including the period of patent term adjustment. QLT091001 for the treatment of Impaired Dark Adaptation (IDA): In 2013, the company initiated a Phase IIa proof-of-concept randomized, multi-center, parallel-group, placebo-controlled trial of QLT091001 in adult subjects with IDA, a condition that results in decreased ability to recover visual sensitivity in the dark after exposure to bright lights. The trial is designed to evaluate the safety profile and effects of QLT091001 on impaired dark adaptation time, glare recovery time and low luminance low contrast best corrected visual acuity. Research and Development As of December 31, 2013, the company’s research and development expenses were $18.5 million. Regulations The research and development, preclinical studies and clinical trials, and ultimately, the manufacturing, marketing and labeling of the company’s products, are subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries. History QLT Inc. was formed in 1981 under the laws of the Province of British Columbia.
qlt inc (QLT:Toronto)
887 Great Northern Way
Vancouver, BC V5T 4T5
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