QLT Announces First Quarter 2016 Results
VANCOUVER, British Columbia, May 05, 2016 (GLOBE NEWSWIRE) -- QLT Inc. (NASDAQ:QLTI) (TSX:QLT) (“QLT” or the “Company”) reported financial results today for the first quarter ended March 31, 2016. Unless otherwise specified, all amounts are reported in U.S. dollars and in accordance with U.S. GAAP.
Synthetic Retinoid Program Update
On April 22, 2016, QLT announced that it had completed enrollment and collection of data from its retrospective, uncontrolled, multicenter Natural History Study in subjects with Inherited Retinal Disease (IRD) in Retinitis Pigmentosa and Leber Congenital Amaurosis patients due to underlying RPE65 or LRAT gene mutations. As QLT expected, the preliminary analysis of the study data suggests that IRD subjects, without therapeutic intervention, demonstrate a continuing decline in visual field and eventually visual acuity over time. Given these results, the Company is in the process of finalizing its data analysis and plans to hold discussions with select national European agencies in the second quarter of 2016. The results of this study are expected to provide important data to support the ongoing development of QLT091001 and planned future submissions for regulatory approval in Europe and the U.S., including the potential filing of a marketing authorization application (MAA) with the European Medicines Agency (EMA) for conditional approval in the second half of 2016.
Synthetic Retinoid Program Update
On April 22, 2016, QLT announced that it had completed enrollment and collection of data from its retrospective, uncontrolled, multicenter Natural History Study in subjects with Inherited Retinal Disease (IRD) in Retinitis Pigmentosa and Leber Congenital Amaurosis patients due to underlying RPE65 or LRAT gene mutations. As QLT expected, the preliminary analysis of the study data suggests that IRD subjects, without therapeutic intervention, demonstrate a continuing decline in visual field and eventually visual acuity over time. Given these results, the Company is in the process of finalizing its data analysis and plans to hold discussions with select national European agencies in the second quarter of 2016. The results of this study are expected to provide important data to support the ongoing development of QLT091001 and planned future submissions for regulatory approval in Europe and the U.S., including the potential filing of a marketing authorization application (MAA) with the European Medicines Agency (EMA) for conditional approval in the second half of 2016.