Ocular Therapeutix™ Announces Upcoming Presentation of Interim OTX-TKI Phase 1 Clinical Trial Data at Angiogenesis, Exudation, and Degeneration 2021 – Virtual Edition
Ocular Therapeutix (NASDAQ: OCUL) announced it will present data from its Phase 1 clinical trial of OTX-TKI, an axitinib intravitreal implant aimed at treating wet AMD, at the Angiogenesis, Exudations, and Degeneration Meeting on February 12-13, 2021. The interim data suggests a favorable safety profile and potential efficacy for OTX-TKI in patients, indicating durability in effects lasting up to six months. Presentation details include time and presenter information, highlighting the significance of the findings for future treatment options in retinal diseases.
- Interim data from Phase 1 clinical trial indicates a favorable safety profile for OTX-TKI.
- Efficacy signal suggests potential for lasting effects (up to six months) in wet AMD patients.
- None.
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, announced its intention to present data from its Phase 1 clinical trial of OTX-TKI, an axitinib intravitreal implant for the treatment of patients with wet age-related macular degeneration (wet AMD) and other retinal diseases, at the upcoming Angiogenesis, Exudations, and Degeneration 2021 Meeting being held virtually on February 12-13th.
Details of Ocular’s Presentation are as follows:
TITLE: Intravitreal Hydrogel-Based Axitinib Implant (OTX-TKI) for the Treatment of Neovascular AMD: Phase 1 Trial Update
PRESENTER: Andrew A. Moshfeghi, MD, MBA, Associate Professor of Clinical Ophthalmology; Medical Director of the USC Roski Eye Institute; Director of Clinical Trials; Director of the Vitreoretinal Surgery Fellowship Program; and Director of the Medical Retina Fellowship Program
PRESENTATION DATE AND TIME: Saturday, February 13, 2021, 12:30 p.m. ET
“We are pleased to be presenting an update on OTX-TKI at the upcoming Angiogenesis meeting,” said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. “OTX-TKI is an intravitral implant of axitinib delivered via injection, leveraging a new administration and mechanism of action for the treatment of patients with wet AMD and other retinal diseases. We are particularly encouraged with the interim data presented to date from the Phase 1 trial. The data support the product’s safety profile and signal its potential biological activity and durability in patients with wet AMD across the first two dose cohorts and a portion of the third dose cohort for up to six months or longer in some cases.”
The presentation can be accessed February 13th on the “Events and Presentations” section of the Ocular Therapeutix website.
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 bioresorbable hydrogel-based formulation technology. Ocular Therapeutix’s first commercial drug product, DEXTENZA, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Ocular Therapeutix has also submitted a Supplemental NDA for DEXTENZA to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication. Ocular Therapeutix’s earlier stage development assets currently in Phase 1 clinical trials include OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension and OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases. Ocular Therapeutix is currently evaluating OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease in a Phase 2 clinical trial. Also, Ocular Therapeutix has recently filed a Phase 2-enabling investigational new drug application for OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. Ocular Therapeutix's first product, ReSure® Sealant, is an FDA-approved device 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 its presentation at future scientific or medical conferences; the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company’s product candidates; the commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of DEXTENZA; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept for the treatment of retinal diseases including wet AMD; the potential receipt of a target action date under PDUFA; the ongoing development of the Company’s extended-delivery hydrogel depot technology; the size of potential markets for our product candidates; 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; projected net product revenue and other financial metrics of DEXTENZA; the expected impact of the COVID-19 pandemic on the Company and its operations; 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, the timing and costs involved in commercializing DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, 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 Company’s ability to generate its projected net product revenue on the timeline expected, if at all, 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, the severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, any additional financing needs 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 press 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 except as required by law. 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 press release.
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