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QLT announces interim data from a Phase II clinical trial and a device study for the Punctal Plug Drug Delivery System
Date:7/28/2009

g L-PPDS is roughly equivalent to 54 latanoprost eye drops, or about 60% of the amount of drug in eye drops given continuously over three months.

Concurrent with the Phase II clinical trial, punctal plug prototype designs for the sustained delivery system are being tested in an ongoing multicenter study in more than 500 healthy volunteers. Safety, tolerability, comfort, ease of handling and insertion/removal, and retention are being assessed in this study. The overall goal for development is to achieve 90% retention for 90 days. Based on currently available data, preliminary results for one family of designs show an overall retention rate of 75% after eight weeks of follow-up. While this does not yet meet the Company's retention criteria, designs are continuing to be refined and evaluated, with longer-term follow-up on the improved designs anticipated by year-end.

"We are pleased with the progress of our Phase II clinical trial and device program," said Bob Butchofsky, President and Chief Executive Officer of QLT. "The interim data we announced today are encouraging and are in line with the data we reported from our earlier CORE study. The results observed at Week 4 are clinically meaningful and similar to the IOP decrease we saw in the CORE study at the same time point. We believe there is sufficient room to increase the dose of latanoprost to further increase reduction in IOP while maintaining a favorable safety profile, and we look forward to updating you on the clinical progress of our higher dose evaluations. We continue to refine our designs for punctal plugs and anticipate that these will lead to improved retention rates in ongoing clinical trials."

The 44-(micro)g Phase II Study

This study includes two cohorts and is an ongoing, Phase II, open-label, multicenter study conducted to investigate the safety and preliminary efficacy of L-PPDS containing either 44-(micro)g (first cohort) or 81-(micro)g (second coho
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SOURCE QLT Inc.
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