Ocular Therapeutix™ to Present Pre-Clinical and Clinical Data at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
April 25, 2022BEDFORD, Mass.–(BUSINESS WIRE)–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 multiple scientific presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held May 1-4 in Denver, Colorado and May 11-12 virtually.
“At this year’s Annual Meeting, we are thrilled to be presenting clinical and pre-clinical data from our lead programs as well as from programs that are a part of our early-stage pipeline,” commented Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. “The data being presented continues to highlight the depth of our hydrogel platform and its potential to provide solutions that improve efficacy and reduce the complexity and burden of the current standard of care for a number of diseases in both the front and back-of-the-eye. As we continue to advance our pipeline forward, we remain excited about the progress we have seen to-date and future expansion capabilities into other areas of unmet need.”
Ocular Therapeutix Presentations at ARVO:
OTX-DED (dexamethasone intracanalicular insert) (Dry Eye Disease):
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Title: Efficacy and Safety of OTX-DED Dexamethasone Intracanalicular Insert in Subjects with Dry Eye Disease: A Multicenter, Randomized, Vehicle-Controlled Phase 2 Study
Session Title: Dry Eye, Clinical
Session Date/Times: May 2, 2022 from 2:30 PM to 4:30 PM EDT
Presentation type: Poster session (virtual)
Presenter: Lisa Nijm
OTX-TKI (axitinib intravitreal implant) (wet AMD and other retinal diseases):
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Title: A Safety and Pharmacokinetic Study of a Novel Hydrogel-based Axitinib Intravitreal Implant (OTX-TKI) in Non-Human Primates
Session Title: AMD and diabetic retinopathy
Session Date/Times: May 1, 2022 from 2:15 PM to 4:15 PM EDT
Presentation type: Poster session
Presenter: Erica Kahn
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Title: A 6-Month GLP Toxicology Study of a Novel Hydrogel-based, Axitinib Intravitreal Implant (OTX-TKI) in Non-Human Primates
Session Title: AMD and diabetic retinopathy
Session Date/Times: May 1, 2022 from 2:15 PM to 4:15 PM EDT
Presentation type: Poster session
Presenter: Chintan Patel
OTX-TIC (travoprost intracameral implant) (primary open-angle glaucoma or ocular hypertension):
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Title: Safety and Pharmacodynamic Assessment of Repeated Intracameral Travoprost Implant Administration in Beagle Dogs
Session Title: Pharmacology/cellular mechanisms
Session Date/Times: May 3, 2022 from 3:00 PM to 5:00 PM EDT
Presentation type: Poster session
Presenter: Charles Blizzard
Early-stage pipeline programs:
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Title: Pharmacokinetics of a Hydrogel-based Besifloxacin Intracanalicular Insert in Canines
Session Title: Anti-inflammatory agents, antibiotics and antivirals
Session Date/Times: May 2, 2022 from 5:00 PM to 7:00 PM EDT
Presentation type: Poster session
Presenter: Megan Priem
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Title: Pharmacokinetics of a Hydrogel-based Nepafenac Intracanalicular Insert in Canines
Session Title: Aqueous humor dynamics and IOP
Session Date/Times: May 1, 2022 from 5:36 PM to 5:53 PM EDT
Presentation type: Paper session
Presenter: Oktay Uzun
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 includes OTX-TKI (axitinib intravitreal implant), currently in Phase 1 clinical trials for the treatment of wet AMD and other retinal diseases. OTX-TIC (travoprost intracameral implant) recently began a Phase 2 clinical trial to evaluate the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix has also completed Phase 2 clinical trials for OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease. Ocular Therapeutix’s first product, ReSure® Sealant, is an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the commercialization of DEXTENZA®, ReSure® Sealant, or any of the Company’s product candidates; the commercial launch of, and the effectiveness of and amounts applicable to reimbursement codes for, DEXTENZA; the conduct of post-approval studies of and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; the Company’s sales and marketing strategy; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of OTX-CSI for the chronic treatment of dry eye disease, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, and OTX-TKI for the treatment of retinal diseases including wet AMD; 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 operations of Company collaborations, including any potential future costs or payments thereunder; projected net product revenue, in-market sales and other financial and operational metrics of DEXTENZA and ReSure Sealant; potential market sizes for indications targeted by the Company’s product candidates, if approved; 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 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, ReSure Sealant or any product candidate that receives regulatory approval, including the conduct of post-approval studies, the ability to successfully develop and commercialize products for the ophthalmology office setting, the ability to retain regulatory approval of DEXTENZA, ReSure Sealant or any 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 such as the data reported in this release will be indicative of the results of subsequent clinical trials, 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, the severity and duration of the COVID-19 pandemic including its effect on the Company’s revenues and relevant regulatory authorities’ operations, any additional financing needs 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.
Contacts
Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
[email protected]
or
Westwicke, an ICR Company
Chris Brinzey, 339-970-2843
Managing Director
[email protected]
Media
Ocular Therapeutix
Scott Corning
Senior Vice President, Commercial
[email protected]