Ocular Therapeutix is 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.
In the trial, which follows a successful travoprost punctum plug feasibility study, Ocular travoprost punctum plugs are inserted into the proximal nasolacrimal canal, and release the 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 one-month duration.
Ocular Therapeutix president and CEO Dr Amar Sawhney said having demonstrated proof of concept in the feasibility study, the company is extending the length of drug delivery to two months for the Phase II trial.
"Extending treatment duration for the disease is a key milestone for our company's path to commercialisation," Sawhney said.
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.
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. Elevated intraocular pressure is the most important risk factor for glaucoma.
The Umhlanga Hospital Medical Centre principal investigator Pierre Wassermann said travoprost punctum plugs may help to overcome issues of daily self-administration of medication, which can lead to potential patient non-compliance.
"Additionally, maintaining continuous drug presence via sustained delivery may be an improvement over fluctuating drug levels resulting from daily topical therapy," Wassermann said.