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 that data from its preclinical research will be highlighted in presentations and posters at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, April 29 – May 3, in Honolulu, HI. The presentations include preclinical data for product candidates OTX-TIC (travoprost implant), an intracameral injection for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension and OTX-TKI (tyrosine kinase inhibitor implant), an intravitreal injection for the treatment of retinal neovascular diseases.
“The data presented at ARVO highlight the promise of our hydrogel-based technology platform as our OTX-TIC and OTX-TKI product candidates enter clinical development. Our sustained release therapies are intended to address unmet needs across several areas in ophthalmology,” said Michael Goldstein, M.D., Chief Medical Officer of Ocular Therapeutix. “We are excited about our progress to date and remain dedicated in our work to enhance the strength and depth of our pipeline.”
Ocular Therapeutix Presentations at ARVO, Honolulu, HI:
Efficacy & Tolerability of OTX-TKI, a Sustained Hydrogel Delivery
System for a Tyrosine Kinase Inhibitor, in a VEGF Induced Retinal
Leakage Model Through 12 Months.
Tuesday, May 1, 2018; 4:00 PM – 4:15 PM - Room 314
Safety Analysis of a Sustained Release Travoprost Intracameral
Hydrogel Implant in Beagle Dogs.
Monday, April 30, 2018; 8:15 AM – 10:15 AM in Exhibit/Poster Hall
Efficacy and Pharmacokinetics of a Sustained Release Travoprost
Intracameral Hydrogel Implant in Beagle Dogs.
Monday, April 30, 2018; 8:15 AM – 10:15 AM in Exhibit/Poster Hall.
Effectiveness of Sustained Release TKI Hydrogel Combined with
Bevacizumab in a VEGF Induced Retinal Leakage Model Through 12 Months.
Sunday, April 29, 2018; 4:00 PM – 4:15 PM in Exhibit/Poster Hall
About OTX-TIC (travoprost implant) for Intracameral Injection
OTX-TIC is designed to be a bioresorbable implant containing micronized travoprost that is injected into the anterior chamber of the eye, with a target duration of drug delivery of four to six months. Preclinical studies in beagles have demonstrated sustained intraocular pressure reduction and maintenance of drug levels in the aqueous humor. Ocular Therapeutix has submitted an investigational new drug application (IND) for OTX-TIC and plans to initiate clinical trials in the second quarter of 2018.
About OTX-TKI (tyrosine kinase inhibitor implant) Intravitreal Injection
OTX-TKI is a bioresorbable hydrogel that contains TKI particles in an injectable fiber. OTX-TKI is designed to deliver drug to the target tissues for a period of up to 12 months, thereby potentially extending the dosing interval from the 1-2 month frequency needed with the current standard of care. Ocular Therapeutix has performed pharmacokinetic, efficacy, and tolerability preclinical testing on OTX-TKI and plans to initiate a Phase 1 clinical trial in the second quarter of 2018.
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, as well as sustained release intravitreal implants for the treatment of retinal diseases. These implants include the development of OTX-TKI, a tyrosine kinase inhibitor (TKI), and, in collaboration with Regeneron, an extended release protein-based anti-vascular endothelial growth factor (VEGF) trap. 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 inflammation and pain, 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, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release hydrogel depot 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