Ocular Therapeutix™ Announces Interim 10-month Data from the Ongoing U.S. Phase 1 Clinical Trial Evaluating OTX-TKI for the Treatment of Wet AMD
All OTX-TKI treated subjects who were rescue-free at the Month 7 interim analysis remained rescue-free, extending the 73% rescue-free rate up to Month 10
CSFT and BCVA measurements at 10 months were comparable between OTX-TKI treated subjects and aflibercept treated subjects
OTX-TKI continued to be generally well tolerated with no drug-related serious adverse events through Month 10
Conference call to discuss results to be held on
“We are very pleased to see this latest 10-month data that support OTX-TKI's potential to set a new standard for durability in the treatment of wet AMD,” said
Summary of Interim 10-month Data from the Ongoing
As of the data cutoff of
The interim results showed subjects treated with a single OTX-TKI implant demonstrated stable and sustained BCVA (mean change from baseline of -0.3 letters) and CSFT (mean change from baseline of -1.3 µm) in the OTX-TKI arm at 10 months, which was comparable with the aflibercept arm (mean change from BCVA baseline of -0.8 letters; mean change from CSFT baseline of -4.5 µm). The 73% of subjects who were rescue-free up to Month 7, continued to demonstrate OTX-TKI’s extended duration of action and remained rescue-free up to Month 10. Overall, a 92% reduction in treatment burden was observed in OTX-TKI treated subjects for up to 10 months.
“We are very encouraged by the interim 10-month data being presented that builds upon the interim 7-month data shared last year at the
“Efficacious treatment options are available for our patients with wet AMD, but there is a big unmet need for a treatment that can be effective for more than 3 to 4 months with a single injection. The reduction in treatment burden seen over the first 10 months in patients in the OTX-TKI
The Company plans to meet with the FDA to discuss potential future clinical trial requirements. Subject to those discussions and obtaining the necessary financing, which could be provided through a strategic alliance, the Company intends to initiate a pivotal trial in wet AMD in the third quarter of 2023. Per protocol, the Company will continue to follow subjects in the Phase 1 trial at least until their respective one-year anniversaries of initial dosing. Given the potential broad applicability of OTX-TKI to other retinal diseases, the Company initiated a
Conference Call & Webcast Information
Members 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 Wet Age-Related Macular Degeneration
Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss affecting approximately 14 million individuals globally and 2 million in
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA® or any of the Company’s products or product candidates; the development and regulatory status of the Company’s product candidates, such as the Company’s development of OTX-TKI for the treatment of retinal diseases including wet AMD and diabetic retinopathy; the Company’s plans to advance the development of OTX-TKI; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the potential utility of any of the Company’s product candidates; the size of the potential market for OTX-TKI; the Company’s ability to fund the planned and future clinical development of its product candidates whether through strategic alliances or other fundraising; the Company’s ability to enter into and perform its obligations under collaborations; 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 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, timing, conduct and outcomes of clinical trials, whether interim clinical trial data such as the data reported in this release will be indicative of the results of the trial upon its completion or subsequent clinical trials in this and other indications, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, 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 severity and duration of the COVID-19 pandemic including its effect on the Company’s revenues and relevant regulatory authorities’ operations, the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all, the Company’s ability to recruit and retain key personnel, and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the
Chief Financial Officer
Source: Ocular Therapeutix, Inc.