Following encouraging results from Ocular Therapeutix's travoprost punctum plug feasibility study, the company is now entering a pilot Phase II clinical trial to examine a two-month sustained release drug (OTX-TP2) for the treatment of ocular hypertension and glaucoma. Ocular Therapeutix's travoprost punctum plugs are inserted into the proximal nasolacrimal canal, and release drug to the ocular surface over the two-month treatment period.
The initial travoprost punctum plug feasibility study, conducted at the Singapore National Eye Center and the National University Hospital in Singapore, examined efficacy of the technology over a 1-month duration. "Having demonstrated proof of concept in our feasibility study, we have extended the length of drug delivery to two months for the pilot Phase II trial," stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. "Extending treatment duration for the disease is a key milestone for our company's path to commercialization."
The pilot Phase II study will enroll twenty patients (up to 40 eyes) at the Umhlanga Hospital Medical Centre and Netcare Alberlito Hospital in South Africa. Patients with documented ocular hypertension or open-angle glaucoma, the most common form of the disease, will be evaluated for reduction of intraocular pressure from baseline and retention of the plug through two months. Elevated intraocular pressure is the most important risk factor for glaucoma.
Glaucoma is a chronic disease which must be monitored and treated for life, impacting more than 2 million Americans, and represents a $5 billion market worldwide. The current mode of treatment for the disease is topical prescription drops which must be taken daily and at regular intervals to prevent progression of the disease. However, topical prescriptions 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.
"Travoprost Punctum Plugs may help to overcome issues of daily self-administration of medication leading to potential patient non-compliance," stated Pierre Wassermann, Principal Investigator at the Umhlanga Hospital Medical Centre in South Africa. "Additionally, maintaining continuous drug presence via sustained delivery may be an improvement over fluctuating drug levels resulting from daily topical therapy."
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