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news.Ocular Therapeutix has announced a pilot Phase II trial to examine a two-month sustained release drug, OTX-TP2, for the treatment of ocular hypertension and glaucoma, following successful travoprost punctum plug feasibility study
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The pilot study is designed to enrol twenty patients (up to 40 eyes) at the Umhlanga Hospital Medical Centre and Netcare Alberlito Hospital in South Africa.
The ocular travoprost punctum plugs are inserted into the proximal nasolacrimal canal, and release drug to the ocular surface over the two-month treatment period, in the trial.
Ocular president and CEO Amar Sawhney said having demonstrated proof of concept in the feasibility study, the company has extended the length of drug delivery to two months for the pilot Phase II trial.
"Extending treatment duration for the disease is a key milestone for our company’s path to commercialization," Sawhney added.
Patients with documented ocular hypertension or open-angle glaucoma will be evaluated for reduction of intraocular pressure from baseline and retention of the plug through two months.
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 one-month duration.