Ocular Therapeutix has completed its End-of-Phase 2 review with the US Food and Drug Administration (FDA) for its OTX-TP (sustained release travoprost) product candidate for the treatment of glaucoma and ocular hypertension.
Based on this review, the company intends to initiate the first of two Phase 3 clinical trials during the third quarter of 2016.
The FDA has stated that it agrees with the overall Phase 3 clinical development program proposed by Ocular Therapeutix in its briefing package submitted to the FDA, which includes the following:
Two Phase 3 clinical trials that will include an OTX-TP treatment arm and a placebo-controlled comparator arm that would use a non-drug eluting hydrogel-based intracanalicular depot.
The Phase 3 study design will not include a timolol comparator or validation arm.
The study design will not have eye drops, placebo or active, administered in either arm.
A primary efficacy endpoint of statistically superior and clinically meaningful reduction of intraocular pressure (IOP) from baseline with OTX-TP compared to placebo at 60 and 90 days. The FDA has also indicated that they will take into consideration the risk-reward profile of OTX-TP relative to currently available therapies in their evaluation of the Phase 3 clinical trial results.
"We are pleased with the End-of-Phase 2 feedback from FDA concerning our Phase 3 clinical development plan, which proposes a trial design that compares OTX-TP with a placebo arm. We believe this reflects a real-world appropriate clinical study design for this drug product candidate," said Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman.
"OTX-TP has shown a clinically meaningful IOP-lowering effect in clinical trials to date, and may offer an important advancement in the treatment of glaucoma. Importantly, we believe OTX-TP may be able to address the major issue of low patient compliance rates associated with currently approved topical therapies and their chronic, burdensome dosing schedules while potentially improving the safety profile due to the absence of preservatives."
About Glaucoma and Ocular Hypertension
Glaucoma is a chronic, sight-threatening diseases in which elevated levels of intraocular pressure are associated with damage to the optic nerve, which may result in irreversible vision loss. Glaucoma is the second leading cause of blindness in the world. Ocular hypertension is characterized by elevated levels of intraocular pressure without any optic nerve damage. Patients with ocular hypertension are at high risk of developing glaucoma. In the U.S. alone 2.7 million people suffer from glaucoma.
According to IMS Health data, there were 34 million prescriptions and sales of over $2.7 billion of drugs administered by eye drops for the treatment of glaucoma in the U.S. in 2015.
Compliance is seen as the biggest problem with existing therapies for glaucoma, and more than 50% of patients on topical prostaglandin analogs are not compliant with their therapy within the first six months of treatment.
About OTX-TP (Sustained Release Travoprost)
OTX-TP (sustained release travoprost) is a preservative-free drug product candidate that resides within the canaliculus and delivers the prostaglandin analog travoprost to the ocular surface for up to 90 days.
The drug depot is designed to deliver a continuous steady release throughout the treatment period. A fluorescent visualization aid is formulated within the product to enable both the physician and the patient to monitor drug presence throughout the course of therapy.