Ocular Therapeutix™ Announces Initiation of its First Pivotal Clinical Trial of OTX-TKI in Wet AMD
"We are thrilled to announce the initiation of our pivotal trial evaluating OTX-TKI for the treatment of wet AMD and look forward to working with clinical sites across the US," said
“Anti-VEGF agents have revolutionized the treatment of wet AMD, but numerous real-world patients experience vision loss due to their inability to adhere to the demanding treatment regimen involving frequent injections,” said
“This pivotal trial is thoughtfully designed to satisfy the FDA’s latest guidance in wet AMD, while also balancing the needs of subjects who enter it,” said
The pivotal trial was initiated based on the previously announced positive 12-month top-line data from the Company’s 21-subject U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet AMD. Data from this trial were presented at the Clinical Trials at the Summit 2023 Meeting held in Park City, Utah in June 2023. In that trial, subjects treated with a single implant of OTX-TKI were observed to have an 89% reduction in treatment burden compared to subjects treated with aflibercept while maintaining visual acuity and retinal thickness through 12 months. Subjects in the OTX-TKI arm had mean changes from baseline of -1.0 letters in BCVA and +20.2 μm in CSFT at 12 months, comparable to mean changes from baseline for subjects in the aflibercept arm of +2.0 letters and -2.2 μm. 60% of OTX-TKI subjects remained rescue-free up to 12 months. As of the
OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.
About Ocular Therapeutix, Inc.
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, including the timing and design of the Company’s pivotal trials of OTX-TKI for the treatment of wet AMD; the Company’s plans to advance the development of OTX-TKI; the Company’s cash runway and 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 preclinical and 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, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval, including the conduct of post-approval studies; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the ability to maintain and the sufficiency of product, procedure and any other reimbursement codes for DEXTENZA; the initiation, design, timing, conduct and outcomes of clinical trials, including the first pivotal trial of OTX-TKI for the treatment of wet AMD; uncertainties as to the response from the FDA regarding the SPA submission for OTX-TKI, including the risk that the FDA will not agree with the design of the first pivotal trial under the SPA; the risk that even if the FDA agrees with the design of the first pivotal trial under the SPA, the FDA will not agree that the data generated by the trial could support marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design than the earlier trials; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the
Source: Ocular Therapeutix, Inc.