Latanoprost Punctal Plug Delivery System Conference Call

August 29, 2011 08:30 ET


Karen Peterson – Investor Relations Specialist

Bob Butchofsky – President and Chief Executive Officer

Suzanne Cadden – Vice President, Regulatory and Clinical Affairs


Scott Henry – Roth Capital

Steve Yoo – Leerink Swann

Jeffrey Cohen – Ladenburg Thalmann

Seth Hamot – RRH

Doug Miehm – RBC Capital

Pascal Besman – JMP Securities



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At this time, I’d like to turn the conference over to Karen Peterson, Investor Relations Specialist. Please go ahead.

Karen Peterson – Investor Relations Specialist

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Good morning everyone and welcome to QLT’s conference call. Today’s call will review QLT’s Phase II study for glaucoma using the Latanoprost Punctal Plug Delivery System. If you have not yet received a copy of our press release, you can find it by visiting our website at www.qltinc.com. We’ve also posted to the website a PDF file of the PowerPoint presentation that will be used during today’s call.

Conference call is being webcast live and will be available on our website for the next 30 days. Presenting today is Bob Butchofsky, our President and CEO and Suzanne Cadden, Vice President, Regulatory and Clinical Affairs.

Before I turn the call over to Bob, let me review the Safe Harbor statement. On behalf of the speakers who follow, we caution investors that certain statements in this conference call are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute forward-looking information within the meaning of Canadian securities laws. The purposes of this caution we refer to such statements as forward-looking statements. Forward-looking statements are predictions only which involve known and unknown risks and uncertainties and undue reliance should not be placed on such statements.

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.

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