OCULAR THERAPEUTIX,INC. (NASDAQ:OCUL) Files An 8-K Other Events

OCULAR THERAPEUTIX,INC. (NASDAQ:OCUL) Files An 8-K Other Events
Item 8.01 Other Events.

On February20, 2019, Ocular Therapeutix,Inc. (the “Company”) announced that it had dosed the first patient in its OTX-TKI (tyrosine kinase inhibitor implant) Phase 1 clinical trial for the treatment of wet age-related macular degeneration (“AMD”). The first patient was dosed at the Sydney Retina Clinic in Sydney, Australia.

The Phase 1 trial is a multi-center, open-label study testing the safety, durability, and tolerability of OTX-TKI, a bioresorbable hydrogel fiber implant formulated with a tyrosine kinase inhibitor delivered by intravitreal injection in patients with wet AMD. The trial will evaluate biological activity by measuring retinal thickness using standard optical coherence tomography and following visual acuity over time. OTX-TKI is designed to deliver drug to the target tissues for a period of up to nine months.

Forward Looking Statements

Any statements in this Current Report on Form8-K about future expectations, plans, and prospects for the Company, including the commercialization of ReSure®Sealant, DEXTENZA®or any of the Company’s product candidates; 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 the prospects for approvability of DEXTENZA for post-surgical ocular inflammation or any other indications, OTX-TP for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TIC for the treatment of primary open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the Company’s post-approval studies of ReSure Sealant and the Company’s ongoing communications with the U.S. Food and Drug Administration regarding the Company’s appeal of the warning letter it received regarding ReSure Sealant; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the potential utility of any 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, DEXTENZA or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of ReSure Sealant, DEXTENZA or any product candidate that receives regulatory approval, the initiation, timing 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 Company’s existing indebtedness, the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default, 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 Current Report on Form8-K represent the Company’s views as of the date of this filing. 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 filing.