QLT announces encouraging Phase II data from core study of Punctal Plug Drug Deliv...(p -5.4 +/- 2.7 ...),Health

-5.4 +/- 2.7 -4.8 +/- 3.2 -4.9 +/- 2.1

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Note: Mean IOP changes from baseline in the table are all statistically

significant at P(less than)0.001

The L-PPDS was well-tolerated over the testing period. The overall adverse events ranged from 1.6% to 14.8% and were not dose dependant. The most common adverse events were increased lacrimation (tear production) and ocular discomfort (14.8% and 9.8%, respectively) which were mild and transient in nature and were most likely resolved during the adaptation period to punctal plug wear. Ocular hyperemia and punctate keratitis rates were 1.6% each. At Week 12, patient-reported comfort and tearing scores were favorable: 89% of patients rated L-PPDS comfort as 'no awareness' and 8% 'mild awareness,' while tearing was rated as 'none' (78%), 'occasional' (14%), or 'mild' (5%). The remaining 3% of patients did not have a comfort and tearing assessment at Week 12. In the CORE study, the punctal plug retention rate utilizing a commercially available conventional punctal plug was 76% despite having patients pre-screened for plug retention for eligibility into the trial.

QLT currently plans to initiate a second Phase II trial in patients with OAG or OH over a 12-week period to investigate the efficacy of a proprietary punctal plug prototype in conjunction with a dose of latanoprost that is at least 10-fold higher than the lowest dose used in the CORE study.

Although there was no dose response observed in CORE, the doses tested were closely grouped (less than 1 log unit apart) and represent the low end of potential doses for the product. The study investigated sustained-release doses that were much lower than those present in latanoprost eye drops used over a similar time period.

About Latanoprost Punctal Plug Delivery System (L-PPDS)

The L-PPDS is a novel, sustained and contro
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