Ocular Therapeutix Inc. (NASDAQ:OCUL), based in Bedford, Massachusetts, have announced plans for the further clinical development of a novel sustained release travoprost treatment (OTX-TP) for glaucoma and ocular hypertension. The announcement follows meetings with and feedback from the FDA in relation to which the company expects to initiate two Phase III clinical trials within the 3rd quarter of 2016. The company stated that the planned trials will include an OTX-TP treatment arm and a placebo-controlled comparator arm (employing a non-drug eluting hydrogel-based intracanalicular depot). From a company press release it is understood that OTX-TP will need to show a statistically superior and clinically meaningful reduction of intraocular pressure (IOP), compared to the placebo, as a primary efficacy endpoint.
OTX-TP is a preservative-free sustained release prostaglandin analog which, according to the company, can be inserted non-invasively through the punctum where it resides within the canaliculus to deliver travoprost to the ocular surface over a period of 90 days. The travoprost compund is encapsulated in polylactide microparticles entrapped within a dried biodegradable PEG hydrogel matrix. Upon insertion the hydrogel is understood to swell to conform to the vertical canaliculus to ensure plug retention and release of travoprost for 90 days. The hydrogel is additionally conjugated with fluorescein to facilitate visualization during the insertion procedure, The sustained release strategy is designed to remove the need for daily dosing and thus improve patience compliance. The company stated they had recently completed a Phase 2b Clinical Trial within the United States where the product is understood to have demonstrated a robust IOP reduction, including “clinically significant results at three months” with a single insertion.
Commenting on the announcement, Amar Sawhney, Chief Executive and Chairman of the company stated, “We are pleased with the outcome of our recent meeting with the FDA to discuss the Phase 3 clinical development plan for OTX-TP. We believe that a direct comparison of OTX-TP with a placebo comparator reflects the simplest and most real world appropriate clinical study design for this product. This meeting was an important milestone for advancing this program into the next stage of its development. We expect to initiate the first of two planned Phase 3 clinical trials in the third quarter of 2016 after holding an End of Phase 2 meeting with the FDA and finalizing the protocol for the trials.”