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.

[1]  Douglas R. Anderson.  Automated Static Perimetry , 1992 .

[2]  E. E. Hartmann,et al.  The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. , 2002, Archives of ophthalmology.

[3]  S. Hahn,et al.  Using pharmacy claims data to study adherence to glaucoma medications: methodology and findings of the Glaucoma Adherence and Persistency Study (GAPS). , 2007, Investigative ophthalmology & visual science.

[4]  P. Denis,et al.  Travoprost in the management of open-angle glaucoma and ocular hypertension , 2007, Clinical ophthalmology.

[5]  V. Polo,et al.  Conjunctival hyperaemia with the use of latanoprost versus other prostaglandin analogues in patients with ocular hypertension or glaucoma: a meta-analysis of randomised clinical trials , 2008, British Journal of Ophthalmology.

[6]  H. Quigley,et al.  Adherence and persistence with glaucoma therapy. , 2008, Survey of ophthalmology.

[7]  T. Aung,et al.  Persistence of patients receiving topical glaucoma monotherapy in an Asian population. , 2011, Archives of ophthalmology.

[8]  K. Rohrer,et al.  Compliance and knowledge about glaucoma in patients at tertiary glaucoma units , 2011, International Ophthalmology.

[9]  I. Floriani,et al.  Long-term 24-hour Intraocular Pressure Control With Travoprost Monotherapy in Patients With Primary Open-angle Glaucoma , 2014, Journal of glaucoma.

[10]  I. Floriani,et al.  Safety and efficacy of travoprost solution for the treatment of elevated intraocular pressure , 2015, Clinical ophthalmology.