Previous Statements by QLTI
» QLT CE Discusses Q2 2011 Results - Earnings Call Transcript
» QLT CEO Discusses Q1 2011 Results - Earnings Call Transcript
» QLT CEO Discusses Q4 2010 Results - Earnings Call Transcript
Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. For additional information about the material factors or assumptions underlying such statements and about the material factors that may cause actual results to vary from those expressed or implied in such statements, please consult our press release sent out earlier this morning and available on our corporate website as well as our filings with the U.S. Securities Exchange Commission and the Canadian Securities Regulatory Authorities including the Risk Factors detailed in the most recently filed Annual Report on Form 10-K and quarterly reports on Form 10-Q. QLT undertakes no obligation to update such information to reflect later events or developments except as required by law.And with that, I will turn the call over to Bob. Bob Butchofsky – President and Chief Executive Officer All right. Thanks Karen and good morning everyone. It’s really a pleasure to be able to present some positive data, especially from the study that clearly met the objectives that we were trying to achieve with that. So, I am going to walk through a slide deck that’s available on our website today. Turning to slide two, you can see our forward-looking statements, but on slide three, you can see the top-line study highlights and essentially broadly the Latanoprost Punctal Plug Delivery System as the first minimally invasive drug delivery device that’s been shown effective a decrease in intraocular pressure at clinically significant levels for four weeks. And the two most relevant data points that I will highlight are the change from baseline or reduction from baseline and intraocular pressure and at two weeks that number was 6.2 millimeters of mercury and at four weeks the number was 5.7 millimeters of mercury.
And we call them, we started this study, the goal was to demonstrate a 5 millimeter or greater reduction in intraocular pressure and we have clearly achieved that goal. The mean percentage change in intraocular pressure from baseline at two and four weeks was 24.3% and 22.3% respectively and that’s very closely aligned with the 25% decrease that’s recommended by the American Academy of Ophthalmology’s preferred practice pattern. So, we are extremely excited with the overall results.On slide four, let me give you a little bit of background on the Latanoprost Punctal Plug Delivery System and this trial in particular. This was a Phase II study looking at latanoprost delivered through our proprietary punctal plug. We did simultaneous placement of plugs in both the upper and lower puncta and as a reminder this is the first trial in which we have done that procedure. Again, the development objective was to get a mean reduction and pressure of 5 millimeters or greater. The primary endpoint and this was modified in the April timeframe when we did the study design change was mean change from baseline at two weeks secondary endpoint, was mean change and pressure from baseline at four weeks. We also look at a number of other parameters. In terms of review on slide five, for those of you who are not familiar with this, this is a combination drug device taking advantage of a device called the punctal plug in the top middle frame, that’s combined with the drug-eluting core in the upper left. And then when you marry the two in the top right, it’s a small device that’s designed to be placed in the tear duct of the eye or punctum of the eye using a insertion tool that we have developed and then it’s designed to stay there for up to 90 days and basically take the patient out of the drug administration game. These things are fairly simply inserted either by an ophthalmologist or optometrist in an office-based procedure. Read the rest of this transcript for free on seekingalpha.com