Punctal plug performs well at Phase II

November 10, 2008

The Latanoprost punctal plug drug delivery system (L-PPDS) has performed well in its Phase II CORE trial, according to study data released by the manufacturer, QLT Plug Delivery Inc.

The Latanoprost punctal plug drug delivery system (L-PPDS) has performed well in its Phase II CORE trial, according to study data released by the system's manufacturer, QLT Plug Delivery Inc.

Thirty-eight patients implanted with the L-PPDS, a non-invasive sustained-release drug-eluting device, completed 12 weeks of follow-up in the randomized, double-masked, multicentre study. The patients had a mean age of 65 years (range: 40–87 years) and a mean baseline intraocular pressure (IOP) of 24.4±2.1 mmHg. Patients received a latanoprost dose of 3.5, 14 or 21 µg.

All dose groups achieved a statistically significant reduction in IOP. From baseline to week 12, the overall IOP reduction was 20%. For those receiving a high-dose of latanoprost, a mean IOP reduction of 4.9 mmHg was achieved; for a medium dose, the reduction was 4.8 mmHg, and for a low dose, the reduction was 5.4 mmHg. The L-PPDS was well tolerated; adverse events were mild and transient, and the most common instances were increased tear production and ocular discomfort.

In the next stage of the Phase II trial, QLT will investigate the use of higher doses of latanoprost (minimum 35 µg) with the L-PPDS.