Ocular Therapeutix, Inc. announced today initial results of their sustained release travoprost-loaded punctum plug feasibility study for the treatment of glaucoma. This travoprost punctum plug (OTX-TP1) was evaluated for the reduction of elevated intraocular pressure in subjects with open-angle glaucoma or ocular hypertension over a 30 day period.
Twenty six eyes were treated in 17 patients at the Singapore National Eye Center and the National University Hospital in Singapore. Prior to insertion of the plugs, mean intraocular pressure at baseline for the study group was recorded at 26.3 mm Hg. Intraocular pressure (IOP) decreased by 5.5 mm Hg at day-3 post-insertion, and after 30 days of treatment, mean IOP was 6.5 mm Hg below baseline. The OTX-TP1 is designed to absorb in approximately 4 to 6 weeks, and 88% of plugs were present at the day-30 visit. Plugs remaining in the nasolacrimal canal on day 30 were flushed. One patient demonstrated excessive tearing. Apart from that, there were no ocular complaints outside of normal limits, and patients were comfortable overall.
Results are comparable to topical brand name ophthalmic solutions, Travatan® (Alcon Laboratories, Inc.), Lumigan® (Allergan, Inc.), and Xalatan® (Pfizer, Inc.). However, topical administrations are plagued with issues of non-compliance, which can lead to costly and invasive surgeries, vision impairment, and even blindness. It has been reported that up to 60% of patients do not administer ophthalmic drops as directed, even though patients' perception is that they are compliant with 97% of their dosing. Sustained delivery travoprost punctum plugs may help to circumvent these issues of patient non-compliance by eliminating the need for daily dosing.
"This product has the ability to universally change the way we treat glaucoma," stated Shamira Perera, M.D., Principal Investigator at the Singapore National Eye Center. "Sustained release therapy could be advantageous to elderly patients who have difficulty administering drops, could help alleviate issues of non-compliance, and may be beneficial to anyone diagnosed with glaucoma who would prefer a life without the inconvenience of taking drops every day."
"Data collected from this study validate our technology's ability to provide therapeutic benefits for glaucoma patients, and we plan to extend the duration of therapy," stated Amar Sawhney, President and CEO of Ocular Therapeutix. "Phase II trials, which will be conducted later this year, will examine travoprost plugs for 60 day therapy (OTX-TP2) with a single insertion."
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