Ocular Therapeutix announced the enrollment of the first patient in the first of two planned phase 3 clinical trials with OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension, according to a company news release. OTX-TP is a preservative-free drug product candidate that resides within the canaliculus and is designed to deliver the prostaglandin analog travoprost to the ocular surface for up to 90 days.
The U.S.-based, prospective, multicenter, randomized, parallel-arm, placebo-controlled study is expected to enroll approximately 550 patients with open angle glaucoma or ocular hypertension at 50 clinical sites. Importantly, the phase 3 study design will not include a timolol comparator or validation arm, and will not have active or placebo eye drops administered in either arm. The comparator arm will utilize a non-drug eluting hydrogel-based intracanalicular insert. The primary efficacy endpoint will be statistically superior reduction of intraocular pressure (IOP) from baseline with OTX-TP compared to placebo at 2, 6 and 12 weeks following insertion.
“This is the first phase 3 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,” Robert Noecker, MD, MBA, Ophthalmic Consultants of Connecticut, and Assistant Clinical Professor, Yale University School of Medicine, said in the news release. “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 6 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.”
“This is the first of two planned phase 3 clinical trials that will both include an OTX-TP treatment arm and a placebo-controlled comparator arm using a non-drug eluting hydrogel-based intracanalicular insert,” Amar Sawhney, PhD, President, Chief Executive Officer and Chairman, said in the news release. “This reflects the most appropriate real-world study design, as learnings from previous studies have indicated that the presence of the inserts in the control arm may have inadvertently enhanced the effect of timolol. We expect topline results from the first phase 3 clinical trial to be available in the first half of 2018, and plan to commence the second phase 3 clinical trial in the first half of 2017. With over $2.7 billion in sales of eye drop therapies for the treatment of glaucoma in the U.S. last year, glaucoma is a large and important market opportunity for Ocular Therapeutix.”
Dr. Sawhney continued, “We are also pleased with the results of the refined OTX-TP product configuration we will be using in these studies. Our most recent results from ongoing non-significant risk (NSR) investigational device exemption (IDE) human clinical studies using the non-drug eluting version of the insert show significant improvements in retention rates at three months compared to previous studies.”