Press Release

2024 OIS Retina and ARVO meetings are being held in Seattle, Washington

BEDFORD, Mass., May 03, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, announced multiple presentations at the Ophthalmology Innovation Source (OIS) Retina 2024 (May 4th) and the Association for Research in Vision and Ophthalmology (ARVO) 2024 meetings (May 5-9th) being held in Seattle, Washington.

Presentations at OIS Retina 2024:

• Session Title: “Spotlight on Drug Delivery”
  Session Date/Time: Saturday, May 4th, 11:15 AM – 12:00 PM PDT
  Ocular Presentation: 11:34 – 11:41 AM PDT
  Presenter: Sanjay Nayak, MBBS, PhD, Chief Strategy Officer

• Panel Title: “The View from the Street”
  Session Date/Time: Saturday, May 4th at 5:00 – 5:30 PM PDT
  Moderator: Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer

Presentations at ARVO 2024:

• Oral Presentation: Pharmacodynamic efficacy of second-generation intravitreal axitinib implant (AXPAXLI) in a VEGF challenge rabbit model
  Session Date/Time: Thursday, May 9th 3:30 – 3:45 PM PDT
  Location: Yakima 1 - Seattle Convention Center - Arch Building
  Presenter: Chuck Blizzard, Vice President, Research & Development

• Poster Title: Long-term safety of repeated intravitreal axitinib implant (AXPAXLI) administrations in non-human primates
  Poster Board #: B0299
  Session Date/Time: Monday, May 6th 8:30 – 10:15 AM PDT
  Location: Exhibit Hall – Seattle Convention Center
  Presenter: Chintan Patel, PhD, Associate Director, Nonclinical Development

• Poster Title: Optimized pharmacokinetic profile of intravitreal axitinib implant (AXPAXLI):
  a comparison of first- and second-generation implants
  Poster Board #: B0300
  Session Date/Time: Monday, May 6th 8:30 – 10:15 AM PDT
  Location: Exhibit Hall – Seattle Convention Center
  Presenter: Madhoosudan Patil, PhD, Senior Scientist

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other diseases and conditions of the eye. AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in the first of two planned pivotal Phase 3 trials for wet AMD, the SOL-1 trial, and a Phase 1 clinical trial for the treatment of NPDR. The clinical portfolio also includes PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension.

Ocular’s expertise in the formulation, development and commercialization of innovative therapies of the eye and the ELUTYX platform supported the development and launch of its first commercial drug product, DEXTENZA^®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. ELUTYX is also the foundation for two other clinical-stage assets, 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, as well as several preclinical programs.

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DEXTENZA^® is a registered trademark of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, and ELUTYX™ and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.

About DEXTENZA

DEXTENZA is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus, and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal.

Please see full Prescribing and Safety Information at the DEXTENZA website.

Forward-Looking Statements
Any statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates, including the timing, design, and enrollment of the Company’s Phase 3 trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD and the Company’s planned Phase 3 clinical development program of AXPAXLI for the treatment of diabetic retinopathy; the Company’s plans to advance the development of AXPAXLI, PAXTRAVA and its other product candidates; the potential utility of any of the Company’s product candidates; 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; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL-1 trial, the HELIOS trial, and the planned Phase 3 clinical development program of AXPAXLI for diabetic retinopathy as well as the Company’s other ongoing clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under Special Protocol Assessment for the SOL-1 trial; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not agree that the data generated by the SOL-1 trial supports potential marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials, or whether preliminary or interim data from a clinical trial will be predictive of final data from such trial; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all; 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 & Media
Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
bslattery@ocutx.com