QLT Announces Interim Data for Phase 2 Punctal Plug Delivery System Clinical Trial
August 3, 2009
QLT Inc. has announced interim results from an ongoing Phase II clinical trial and a device study for the punctal plug delivery system. These preliminary results from the ongoing Phase II clinical trial of the 44-µg Latanoprost Punctal Plug Delivery System (L-PPDS) show that the mean change in intraocular pressure (IOP) from baseline was -3.5 mmHg at the Week 4 visit with 36% of patients having an IOP decrease from baseline greater than 5 mmHg.
These results are based on intraocular pressure data from 47 patients treated with the 44-µg L-PPDS for four weeks. The objective of this trial is to evaluate two doses of latanoprost (44 µg and 81 µg) to identify the most promising formulations for a Phase II dose-ranging and a subsequent Phase III registration trial.
The 44-µg L-PPDS is about equivalent to 29 latanoprost eye drops, or about one-third the amount of drug in eye drops given continuously over three months. The 81-µg 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.
The punctal plug prototype designs for the sustained delivery system are also being tested in an ongoing multicenter study in more than 500 healthy volunteers. The safety, tolerability, comfort, ease of handling and insertion/removal, and retention of the punctual plugs are being assessed in this study.
Read the release.
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