Massachusetts-based drug delivery company Ocular Therapeutix is starting a pilot Phase II trial of OTX-TP2, tiny hydrogel plugs implanted in the puncta, or tear drainage ducts, that deliver travoprost directly to the eye for the treatment of ocular hypertension and glaucoma.
The Phase II trial, at the Umhlanga Hospital Medical Center and Netcare Alberlito Hospital in South Africa, will enroll 20 patients (up to 40 eyes) with ocular hypertension or open-angle glaucoma. The plugs have already been tested in a one-month feasibility study, and at the end of the month 88% of plugs were still in place and intraocular pressure (IOP) was reduced.
One of the issues with treating eye disease is compliance, especially as patients with glaucoma tend to be older and don't always find eyedrops easy to use--up to 60% of patients don't use their eye meds as they should. OTX-TP2 delivers travoprost consistently over two months, taking away this non-compliance issue, and delivers a constant level of drug, which may improve outcomes. The plug degrades so it does not need removal at the end of the treatment period.
However, a disadvantage of some punctal plugs is that they can block the drainage of tears (drug-free plugs are used to treat dry eye syndrome), or fall out, and a number of companies are developing alternative delivery routes.
- read the press release