Feasibility study of sustained-release travoprost punctum plug for intraocular pressure reduction in an Asian population.

Purpose: To investigate the efficacy and safety of a punctum plug-based sustained drug release system for a prostaglandin analog, travoprost (OTX-TP), for intraocular pressure (IOP) reduction in an Asian population.

Methods: This is an initial feasibility, prospective, single-arm study involving 26 eyes and a bioresorbable punctum plug containing OTX-TP. An OTX-TP was placed in the vertical portion of the superior or inferior canaliculus of patients with primary open-angle glaucoma or ocular hypertension. The main outcome measure was the IOP-lowering efficacy of OTX-TP at 3 (8 am) and 10, 20, and 30 days (8 am, 10 am, and 4 pm), compared to baseline.

Results: A total of 26 OTX-TP were inserted for 17 subjects. The mean (standard deviation) age was 57.2 (13.8) years. At 10 days, all plugs were still present, and the IOP reduction from baseline was 6.2 (23%), 5.4 (21%), and 7.5 mmHg (28%) at 8 am, 10 am, and 4 pm, respectively. At 10 days, the mean IOP (standard error of mean) was 21.2 (1.2), 20.4 (0.8), and 19.7 (1.0) at 8 am, 10 am, and 4 pm, respectively, showing no discernible IOP trend during the course of the day. At 30 days, plug retention had declined to 42%, and the overall IOP reduction had decreased to 16%.

Conclusion: The sustained-release OTX-TP is able to reduce IOP by 24% (day 10) and 15.6% (day 30), respectively. It is a potentially well-tolerable ocular hypotensive for glaucoma patients with a history of poor compliance.