-
Ocular Therapeutix™ To Present Pre-Clinical and Clinical Data at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
来源: Nasdaq GlobeNewswire / 14 4月 2023 15:01:00 America/Chicago
BEDFORD, Mass., April 14, 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 multiple scientific presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held April 23 - 27 in New Orleans, Louisiana.
“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 Rabia Gurses-Ozden, MD, 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. Specifically, we are excited to have Dr. Andrew Moshfeghi presenting an update on OTX-TKI that will cover preclinical pharmacokinetics, the implant bioresorption process and a review of the 10 month interim results from the ongoing U.S. trial. Overall, we are excited about our progress, across our pipeline, and look forward to sharing these updates at ARVO.”
Ocular Therapeutix Presentations at ARVO:
OTX-TKI (axitinib intravitreal implant) (wet AMD and other retinal diseases):- Title: U.S. Phase 1 Study of Intravitreal Axitinib Implant (OTX-TKI) for Neovascular Age-related Macular Degeneration
Session Title: AMD: New drugs, delivery systems and mechanisms of action 1
Session Date/Times: April 23, 2023 from 6:15 PM to 6:30 PM EDT
Presentation type: Paper session
Presenter: Andrew A. Moshfeghi, M.D.
OTX-TIC (travoprost intracameral implant) (primary open-angle glaucoma or ocular hypertension):
- Title: Preclinical Safety and Tolerability of Repeated Intracameral Travoprost Implant (OTX-TIC) Administrations
Session Title: Clinical Studies and Clinical Research
Session Date/Times: April 26, 2023 from 11:30 AM to 1:25 PM EDT
Presentation type: Poster session
Presenter: Chintan Patel, Ph.D.
- Title: Presence of Medical Conditions that Can Impair Patients with Glaucoma from Administering Topical Glaucoma Medications – A Study using the Sight Outcomes Research Collaborative (SOURCE) Repository
Session Title: Glaucoma Data Science
Session Date/Times: April 23, 2023 from 9:00 AM to 10:45 PM EDT
Presentation type: Poster session
Presenter: Jaqueline Stoutin, M.D.
OTX-DED (dexamethasone intracanalicular insert) and OTX-CSI (cyclosporine intracanalicular insert) (Dry Eye Disease):
- Title: Prevalence of Dry Eyes in Patients with Common Neurological, Musculoskeletal, and Rheumatological Conditions – A Study Using the Sight Outcomes Research Collaborative (SOURCE) Repository
Session Title: Dry Eye (Clinical)
Session Date/Times: April 25, 2023 from 1:30 PM to 1:45 PM EDT
Presentation type: Paper session
Presenter: Alex Valentine, M.D.
Early-stage Pipeline Programs:
- Title: Controlled Release of Adeno-Associated Viruses (AAVs) Using Hydrogel Implants Improve GFP Expression and Reduce Anti-Drug Antibody (ADA) Titers and Inflammation in Rabbits
Session Title: Gene Therapy and Gene Editing for Ocular Disorders
Session Date/Times: April 23, 2023 from 1:00 PM to 2:45 PM EDT
Presentation type: Poster session
Presenter: Steven Lu, Ph.D.
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, such as the Company’s development of and prospects for approvability of OTX-TKI for the treatment of retinal diseases including wet AMD and diabetic retinopathy, OTX-TIC for the treatment of primary open-angle glaucoma or ocular hypertension, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of dry eye disease; the Company’s plans to advance the development of its product candidates or preclinical programs; the Company’s ability to fund the planned and future development of its product candidates, whether through strategic alliances or other fundraising; the potential utility of any of the Company’s product candidates; the size of potential markets for the Company’s product candidates; 2023 financial guidance, including estimated net product revenue; 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 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.comor
Westwicke, an ICR Company
Chris Brinzey, 339-970-2843
Managing Director
chris.brinzey@westwicke.com
- Title: U.S. Phase 1 Study of Intravitreal Axitinib Implant (OTX-TKI) for Neovascular Age-related Macular Degeneration