QLT announces encouraging Phase II data from core study of Punctal Plug Drug Deliv... (ndiana University School of Medicine Dep...)

QLT announces encouraging Phase II data from core study of Punctal Plug Drug Delivery System

Date:10/28/2008

ndiana University School of Medicine, Department of Ophthalmology and a QLT Clinical Advisory Board member. "Non-compliance by glaucoma and OH patients reduces treatment benefits and is associated with a poorer prognosis. The CORE data reaffirms that QLT's punctal plugs could potentially address some of the most frequent barriers to compliance and could represent a huge shift in the way that glaucoma will be treated in the future."

The CORE Phase II Study

This CORE study is a Phase II, randomized, double-masked, parallel-group, multicenter study conducted to investigate the safety and preliminary efficacy of three different concentrations of latanoprost, a prostaglandin analogue with a punctal plug delivery system in patients with open angle glaucoma or ocular hypertension over a 12-week period. Sixty-one patients diagnosed with OAG/OH with a mean age of 65 years (40 to 87 years) were randomly assigned to receive one of three doses (3.5, 14, and 21 (micro)g) of the latanoprost punctal plug delivery system. The mean baseline IOP was 24.4 +/- 2.1 mmHg for the patient population. There was no dose response relationship observed within the dose range studied in CORE.

Summary (mean +/- SD) of the IOP change from baseline (mmHg) for the

three doses over time:

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3.5 (micro)g 14 (micro)g 21 (micro)g

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Week 4 N=20 N=19 N=21

-3.9 +/- 2.7 -3.4 +/- 3.1 -3.2 +/- 3.3

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Week 8 N=17 N=15 N=15

-3.6 +/- 2.4 -4.2 +/- 3.7 -4.4 +/- 2.4

-------------------------------------------------------------------------

Week 12 N=13 N=12 N=13'/>"/>

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QLT announces encouraging Phase II data from core study of Punctal Plug Drug Deliv...(ndiana University School of Medicine Dep...),Health