Very good news During 2014, the Company continued to advance development of QLT091001, its synthetic retinoid product candidate, for the treatment of certain inherited retinal diseases toward pivotal trials. Following meetings with the U.S. Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), in 2014 the Company amended and finalized its proposed pivotal trial protocol to test the safety and efficacy of QLT091001 in subjects with Inherited Retinal Disease phenotypically diagnosed as Leber Congenital Amaurosis ("LCA") or Retinitis Pigmentosa ("RP") caused by RPE65 or LRAT gene mutations ("IRD"). At present, there is no approved therapeutic treatment option for these patients.
In an effort to accelerate the commercial availability of QLT091001 as a treatment option, the Company is currently exploring with the EMA a submission of a Marketing Authorization Application ("MAA") in 2016 for conditional approval of QLT091001 for the treatment of IRD based on the existing clinical data. Advisory meetings with certain European regulatory authorities are scheduled for early 2015. The outcome of these meetings will determine whether the Company proceeds to submit a Marketing Authorization Application for conditional approval with the EMA and decisions concerning the timing of commencement of a pivotal trial. Conditional approval, if granted, would be made subject to specified conditions, including among other things, that the Company complete and have favorable safety and efficacy data from additional studies, including one or more pivotal trials of QLT091001 for IRD.
Read more at https://www.stockhouse.com/news/press-releases/2015/02/26/qlt-announces-fourth-quarter-and-year-end-2014-results#68L0JGtsVh4eewb4.99