US-based biopharmaceutical company Ocular Therapeutix has started enrolling in its first of two planned Phase III clinical trials of OTX-TP to treat glaucoma and ocular hypertension.
OTX-TP (sustained release travoprost) is a drug product candidate without any preservatives that stays within the canaliculus and delivers the prostaglandin analogue travoprost to the ocular surface for up to 90 days.
The drug product candidate has been developed as a continuous steady release product throughout the therapy and its presence can be monitored by both the physician and the patient by a fluorescent visualisation aid formulated within the product.
The US-based, prospective, multicentre, randomised, parallel-arm, placebo-controlled trial will include about 550 patients with open-angle glaucoma or ocular hypertension.
The design of the study will not feature a timolol comparator or validation arm and will not have an active or placebo eye drops administered in either arm.
The comparator arm will use a non-drug eluting hydrogel-based intra-canalicular insert.
The study is primarily focused on determining the superiority of OTX-TP in reducing intraocular pressure (IOP) while being compared to placebo at two, six and 12 weeks following insertion.
Yale University School of Medicine assistant clinical professor ophthalmic consultants of Connecticut Robert Noecker said: “This is the first Phase III clinical trial to be conducted with a non-invasive, sustained release drug candidate for the treatment of glaucoma and represents an important advancement in the field of ophthalmology.
“While currently approved topical therapies are effective when dosed ideally, studies show that more than 50% of patients are not compliant with their therapy within the first six months of treatment.
“This is a very significant issue in the treatment of glaucoma. Sustained release drug candidates such as OTX-TP address this issue directly, by allowing patients who are either unable to acquire, do not remember to, or who incorrectly administer eye drop regimens, to have a convenient way to manage their disease.
“The preservative-free and sustained nature of OTX-TP has the potential to improve the side effect profile as well."