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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

rt) of latanoprost, a prostaglandin analogue, with a punctal plug delivery system, in patients with OAG or OH over a six-week period. Sixty patients diagnosed with OAG/OH with a mean age of 65 years (30 to 90 years) were enrolled into the 44-(micro)g cohort. The mean baseline IOP was 24.5 +/- 2.4 mmHg for the patient population. Of the 60 patients enrolled, 47 (78%) completed Week-4 follow-up, had an IOP measurement at Week 4, and retained the L-PPDS in both eyes through Week 4. In this interim data analysis with currently available information, 13 patients (22%) discontinued L-PPDS treatment early: 11 patients (18%) due to loss of L-PPDS and 2 patients (3%) due to inadequate IOP control.

The L-PPDS has been well-tolerated over the testing period. Based on preliminary data, the overall adverse events range from 1.7% to 11.7%. The most common adverse events are eye itching (commonly seen with initial punctal plug wear and usually a part of adaptation) and eye irritation (occurring 11.7% and 8.3%, respectively). Increased lacrimation (tear production) and ocular discomfort (observed in the CORE study in 14.8% and 9.8% of patients, respectively) are currently reported in 6.7% and 1.7%, respectively, of patients with the 44-(micro)g L-PPDS. Superficial punctate keratitis is reported in one patient (1.7%). No conjunctival or ocular hyperemia has been observed. Week-4 patient-reported comfort and tearing scores for the 44-(micro)g L-PPDS are similar to those seen in CORE at the Week-4 time point: 88% of patients rated L-PPDS comfort as 'no awareness' or 'mild awareness,' while 76% of patients rated tearing as 'none.'

Enrollment is complete and patient follow-up is continuing in the 44-(micro)g cohort. Patients with OAG or OH are currently enrolling into the 81 (micro)g cohort. Another Phase II trial of additional high-dose formulations is planned to begin in the third quarter of 2009.

Two supportive Phase II trials are ongoing. The first trial eval
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SOURCE QLT Inc.
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