BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced the treatment of the first patient in a Phase 1, open-label, proof-of-concept clinical trial being conducted in the United States for OTX-TIC, a bioresorbable travoprost implant delivered via an intracameral injection for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension.
“One of the biggest unmet needs in ophthalmology, and in glaucoma in particular, is solving the problem of non-compliance,” said Michael Goldstein, M.D., Chief Medical Officer of Ocular Therapeutix. “OTX-TIC is designed to directly address compliance issues by delivering travoprost over the course of several months with a single implant. We are excited to initiate this U.S. clinical trial in patients with glaucoma and ocular hypertension as we continue to advance our pipeline.”
In preclinical studies, OTX-TIC has demonstrated an acceptable safety profile and a marked reduction in intraocular pressure. OTX-TIC features a sustained release profile and is designed to support dosing with a duration of four to six months in a single administration.
This U.S.-based, Phase 1, multi-center, open-label, prospective, proof-of-concept clinical trial will evaluate the safety, efficacy, durability, and tolerability of OTX-TIC in patients with primary open-angle glaucoma or ocular hypertension.
About OTX-TIC (travoprost implant) for Intracameral Use
OTX-TIC is a bioresorbable intracameral implant containing micronized travoprost that is injected into the anterior chamber of the eye and is intended for patients with glaucoma with a target duration of drug delivery of four to six months. Preclinical studies in beagles have demonstrated maintenance of drug levels in the aqueous humor and a sustained lowering of intraocular pressure.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel-based formulation technology. Ocular Therapeutix’s lead product candidate, DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use, has completed Phase 3 clinical development for the treatment of ocular pain and inflammation following ophthalmic surgery. OTX-TP (travoprost insert) is in Phase 3 clinical development for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension. The Company’s earlier stage assets include OTX-TIC, a sustained release travoprost intracameral implant for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension and two sustained release intravitreal implants for the treatment of retinal diseases. The intravitreal implants include OTX-TKI, a tyrosine kinase inhibitor (TKI) being developed for the treatment of wet age-related macular degeneration, and OTX-IVT, a sustained release formulation of the anti-vascular endothelial growth factor (VEGF) aflibercept, being developed in collaboration with Regeneron. Ocular Therapeutix's first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including the development and regulatory status of the Company’s product candidates, such as the Company’s regulatory submissions for and the timing and conduct of, or implications of results from, clinical trials of DEXTENZA™ for the treatment of post-surgical ocular pain and inflammation, including with respect to manufacturing deficiencies identified by the Food and Drug Administration (FDA), the Company’s expectations regarding resubmitting its NDA to the FDA and the prospects for approvability of DEXTENZA for these indications, the Company’s clinical development of DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry eye disease, OTX-TP for the treatment of mild to moderate glaucoma and ocular hypertension, OTX-TIC for the treatment of moderate to severe glaucoma and ocular hypertension, and OTX-TKI for the treatment of wet age-related macular degeneration, the ongoing development of the Company’s sustained release hydrogel technology, the potential utility of any of the Company’s product candidates, potential commercialization of the Company’s product candidates, the potential benefits and future operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder, the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure® Sealant or any product candidate that receives regulatory approval, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources, the outcome of the Company’s ongoing legal proceedings and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.