QLT reports positive 12-week results from trial of punctal plug delivery system

VANCOUVER, British Columbia — QLT has reported positive 12-week results for its CORE study, a phase 2 proof-of-concept trial of its punctal plug delivery system for treating patients with open-angle glaucoma and ocular hypertension, the company announced in a press release.

The study evaluated the safety and efficacy for delivering three sustained release concentrations of Xalatan (latanoprost 0.005%, Pfizer) among 61 patients with an average IOP of 24.4 mm Hg at baseline. Specifically, these patients received 3.5 µg, 14 µg or 21 µg concentrations of the drug.

Of these 61 patients, 23 patients discontinued before the 12-week follow-up visit, of which 19 patients experienced inadequate IOP control and four patients experienced loss of the punctal plug delivery system in both eyes, according to the release.

Among those who completed the study, the average 12-week IOP reduction was 5.4 mm Hg for patients who received the low dose of latanoprost, 4.8 mm Hg for patients who received the medium dose and 4.9 mm Hg for patients who received the high dose, representing a 20% reduction in IOP. In addition the researchers reported that the punctal plug delivery system was generally well-tolerated for the duration of the study.

The most common adverse events included increased lacrimation in 14.8% of patients and ocular discomfort in 9.8% of patients; however, both were most likely resolved during the adaptation period to punctal plug wear.

At 12 weeks, patient-reported comfort and tearing scores were favorable, with 89% of patients rating the delivery system's comfort as "no awareness" and 78% of patients rating tearing as "none," the release said.

QLT plans to initiate a similar second phase 2 trial of the proprietary punctal plug prototype for delivering a concentration of latanoprost that is at least 10 times higher than the lowest dose used in the CORE study, the release said.