Ocular Therapeutix™ To Present 12-Month Top-Line Data from U.S.-Based Phase 1 Clinical Trial of OTX-TKI in Wet Age-Related Macular Degeneration at the 2023 Clinical Trials at the Summit Annual Meeting
BEDFORD, Mass., June 05, 2023 (GLOBE NEWSWIRE) — 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 that 12-month data from the U.S.-based Phase 1 trial evaluating OTX-TKI for the treatment of wet AMD will be presented at the 2023 Clinical Trials at the Summit Annual Meeting being held on June 10th in Park City, Utah. The Company will also participate in a panel discussing the challenges of bringing novel treatments to the market. Ocular Therapeutix is also sponsoring a presentation discussing the Company’s proprietary bioresorbable hydrogel-based formulation technology and retina focused clinical programs. A conference call discussing the 12-month data from the U.S.-based Phase 1 clinical trial of OTX-TKI presented at the Clinical Trials at the Summit will be hosted by the Ocular Therapeutix management team on Monday, June 12th at 8:30 AM ET.
“We look forward to presenting the 12-month data update from our U.S.-based trial evaluating OTX-TKI for the treatment of wet AMD,” stated Rabia Gurses Ozden, MD, Chief Medical Officer of Ocular Therapeutix. “Our most recent update at 10-months observed that CSFT and BCVA measurements at 10 months were comparable between OTX-TKI treated subjects and aflibercept treated subjects with a 92% reduction in treatment burden in the OTX-TKI arm. This new data will include additional information regarding the pharmacodynamics of OTX-TKI at month 12.”
Presentations at Clinical Trials at the Summit:
- 12-Month Update on Randomized, Controlled, Trial of OTX-TKI (Axitinib Intravitreal Implant) for the Treatment of Wet AMD
Date / Time: Saturday, June 10th at 4:29 PM MDT
Presenter: Arshad M. Khanani, MD, Director of Clinical Research at Sierra Eye AssociatesThe presentation will be posted on the Company’s website at approximately 4:30 PM MDT the same day under the Investors tab, Events and Presentations/Scientific and Medical Presentations.
- Challenges of Bringing Novel Treatment Options to the Market
Panel Date/Times: Saturday, June 10th at 10:44 AM MDT
Panelists: Mohamed Genead, Alexander Hardy, Antony Mattessich, Reenie McCarthy, Joel Naor, Victor Perlroth
Moderator: Jeffrey Heier, MD, Director of the Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston and member of the Board of Directors, Ocular Therapeutix, Inc.
- Ocular Therapeutix: Transforming Ophthalmic Care with Innovative Therapies
Sponsored presentation Date/Times: Saturday, June 10th at 5:03 PM MDT
Presenter: Peter K. Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine and Chief Medical Advisor, Retina at Ocular Therapeutix
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 an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. Ocular Therapeutix’s earlier stage development assets include: OTX-TKI (axitinib intravitreal implant), currently in Phase 1 clinical trials for the treatment of wet AMD and diabetic retinopathy; OTX-TIC (travoprost intracameral implant), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension; and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease; and OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease, both of which have completed Phase 2 clinical trials.
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, 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 clinical trial data will be indicative of the results of subsequent clinical trials in the same or other indications or that interim data will be indicative of the full data from a clinical trial, uncertainties as to the timing and availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s ability to enter into and perform its obligations under collaborations and the performance of its collaborators under such collaborations, 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 meet supply demands, the Company’s ability to generate its projected net product revenue and in-market sales 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, any additional financing needs, 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 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, whether as a result of new information, future events or otherwise, 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.
Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
dnotman@ocutx.com
or
ICR Westwicke
Chris Brinzey, 339-970-2843
Managing Director
chris.brinzey@westwicke.com
Media
ICR Westwicke
OcularPR@icrinc.com
