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Punctal plug delivery system shows good safety, efficacy
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PHOENIX – A phase 2 study evaluating the safety and efficacy of a punctal plug delivery system with latanoprost when used in subjects with ocular hypertension or open-angle glaucoma observed a significant reduction in IOP from baseline, according to a poster presentation here at Academy 2012.
The treatment with the Latanoprost Punctal Plug Delivery System (QLT Inc.) was safe and generally well tolerated, despite a high incidence of tearing associated with plug wear, the study authors, David G. Evans, OD, and Carolyn Repke, MD, said in the poster.
The study included 95 subjects and used a later-stage proprietary lower punctal plug and an early-stage prototype upper punctal plug based on a modified commercially available plug, with a combined dose of 141 µg.
After 2 weeks, subjects showed a statistically significant drop in IOP from baseline, with IOP falling an average of 6.2 mm Hg. Seventy-three percent of subjects’ IOP dropped at least 5 mm Hg from baseline, while 51% had their IOP drop at least 6 mm Hg.
After 4 weeks, IOP decrease from baseline was clinically significant at 5.68 mm Hg. Additionally, 60% of patients showed an IOP decrease of at least 5 mm Hg from baseline and 47% showed a decrease of at least 6 mm Hg.
“Based on these early results, the Latanoprost Punctal Plug Delivery System may be able to deliver long-lasting clinically significant IOP reduction, and the procedure appears to be relatively safe, minimally invasive and simple to perform,” the study authors said.
Disclosure: The study was sponsored by QLT Inc.