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January 28, 2013
08:15 EDTQLTIQLT Inc. decided to independently develop QLT091001 after review
QLT Inc. issued a letter to its shareholders outlining the company's recent progress and its 2013 objectives. QLT said expects its recently augmented Synthetic Oral Retinoid leadership team to meet with the FDA by the end of Q1 2013 to discuss the most prudent development path to advance QLT091001. Until the aforementioned FDA meeting is concluded, QLT does not expect to provide timelines for potential pivotal trial initiation. The company added that after evaluating the strategic options available to enhance shareholder value with respect to its Synthetic Oral Retinoid program, the board has determined at this time that independently developing QLT091001 is the most value enhancing path forward for QLT shareholders. Also, QLT reiterated its commitment to return both a significant and appropriate amount of capital to shareholders in the near term. The company's board said it hopes to be able to complete all or a significant portion of its return of capital program in the first half of 2013.
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December 5, 2014
07:04 EDTQLTIQLT Inc. announces results from QLT091001 Phase 2a clinical trial
QLT Inc. announced results from its multi-center, Phase 2a clinical trial of repeated treatments of oral QLT091001 in adult subjects with early age-related macular degeneration, or AMD, and impaired dark adaptation and/or impaired low luminance vision. The Company previously announced positive results from its Phase 1b clinical trials for QLT091001 in subjects with the rare inherited retinal degenerative diseases, Leber Congenital Amaurosis, or LCA, and Retinitis Pigmentosa, or RP. In this Phase 2a trial, oral doses of QLT091001 dosed once per week for 3 consecutive weeks with one additional dose the day after the third dose, showed trends in improvement in dark adaptation rate and in glare recovery time relative to placebo. QLT091001 treatment had an acceptable safety profile and was well-tolerated. David Saperstein, MD, QLT's Chief Medical Advisor, stated, "Dark adaptation and glare recovery in elderly patients, especially in patients with AMD, are a growing problem in our aging population. The trend towards rapid improved dark adaptation and glare recovery times in this small placebo-controlled trial is encouraging. This study represents the first clinical trial with QLT091001 outside of rare orphan disease indications. These encouraging proof of concept results warrant further research aimed at refining the dosing, and endpoint evaluation to further establish the clinical significance of these findings."

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