QLT Inc. (QLTI) Reports Statistically Significant Data from L-PPDS Phase 2
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QLT Inc. (Nasdaq: QLTI) today announced results of its Phase II clinical study on the efficacy and safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in subjects with ocular hypertension (OH) and open-angle glaucoma (OAG).
From the release:
"The Phase II trial featured simultaneous placement of punctal plugs in both the upper and lower puncta for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily administered Xalatan eye drops. The Company's overall drug development objective was a mean reduction in IOP of 5 mmHg or greater. The primary endpoint in this Phase II study was the mean change in IOP from baseline (measured as mmHg) at 2 weeks. Secondary endpoints were the mean change in IOP from baseline at 4 weeks and mean percentage change in IOP from baseline at 2 weeks and 4 weeks.
A total of 95 ITT (Intent to Treat) subjects were included in the L-PPDS treatments in this study. The mean IOP at baseline was 25.8 mmHg for this group.
After 2 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of -6.2 mmHg (95% C.I. -6.8, -5.6). At the end of 2 weeks, 73% of subjects showed an IOP reduction vs. baseline of 5 mmHg or greater and 51% of subjects showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at 2 weeks was -24.3%, which was statistically significant (95% C.I. -26.7, -21.9).
After 4 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of -5.7 mmHg (95% C.I. -6.5, -4.9). At the end of 4 weeks, 60% of subjects showed an IOP reduction vs. baseline of 5 mmHg or greater and 47% of subjects showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at 4 weeks was also statistically significant at 22.3% (95% C.I. -25.4, -19.2). Results reported in earlier Phase II L-PPDS studies using different L-PPDS plug designs and doses did not achieve these levels of IOP reduction over a 4 week treatment period."
From the release:
"The Phase II trial featured simultaneous placement of punctal plugs in both the upper and lower puncta for delivery of a daily drug load with a goal of enabling comparable clinical outcomes to that of daily administered Xalatan eye drops. The Company's overall drug development objective was a mean reduction in IOP of 5 mmHg or greater. The primary endpoint in this Phase II study was the mean change in IOP from baseline (measured as mmHg) at 2 weeks. Secondary endpoints were the mean change in IOP from baseline at 4 weeks and mean percentage change in IOP from baseline at 2 weeks and 4 weeks.
A total of 95 ITT (Intent to Treat) subjects were included in the L-PPDS treatments in this study. The mean IOP at baseline was 25.8 mmHg for this group.
After 2 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of -6.2 mmHg (95% C.I. -6.8, -5.6). At the end of 2 weeks, 73% of subjects showed an IOP reduction vs. baseline of 5 mmHg or greater and 51% of subjects showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at 2 weeks was -24.3%, which was statistically significant (95% C.I. -26.7, -21.9).
After 4 weeks of L-PPDS treatment, IOP showed a statistically significant mean change from baseline of -5.7 mmHg (95% C.I. -6.5, -4.9). At the end of 4 weeks, 60% of subjects showed an IOP reduction vs. baseline of 5 mmHg or greater and 47% of subjects showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at 4 weeks was also statistically significant at 22.3% (95% C.I. -25.4, -19.2). Results reported in earlier Phase II L-PPDS studies using different L-PPDS plug designs and doses did not achieve these levels of IOP reduction over a 4 week treatment period."
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