Ocular Therapeutix™ Announces Upcoming Presentation of Interim OTX-TKI Phase 1 Clinical Trial Data at Angiogenesis, Exudation, and Degeneration 2022 Meeting and OTX-TIC Phase 1 Clinical Trial at Glaucoma 360

Rhea-AI Summary

Ocular Therapeutix (NASDAQ:OCUL) announced its intention to present data from two Phase 1 clinical trials at upcoming medical meetings. The data on OTX-TKI, an axitinib implant for wet AMD, will be shared at the Angiogenesis Meeting on February 12, 2022. Meanwhile, OTX-TIC, a travoprost implant for glaucoma, will be presented at the Glaucoma360 Meeting on February 11, 2022. The interim data highlighted safety and efficacy, with over 60% of OTX-TKI subjects showing extended activity over six months. The company aims to begin a Phase 2 trial for OTX-TIC soon.

Positive

• OTX-TKI shows a promising safety profile with over 60% of subjects experiencing six months or more of activity.
• OTX-TIC demonstrates a clinically meaningful reduction in intraocular pressure for over six months with a single implant.
• Ocular Therapeutix is advancing towards Phase 2 trials for both OTX-TKI and OTX-TIC.

Negative

• None.

BEDFORD, 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, today announced its intention to present data at two medical meetings. Data from the Phase 1 Australian-based 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, will be presented at the Angiogenesis, Exudation, and Degeneration 2022 Meeting being held on February 11-12th. The Company will also present data from the Phase 1 US-based clinical trial of OTX-TIC, an intracameral implant of travoprost for the treatment of glaucoma and ocular hypertension at the Glaucoma 360 Meeting on February 11th.

Details of Ocular’s Presentation at Angiogenesis, Exudation, and Degeneration 2022 Meeting are as follows:

TITLE: Update on OTX-TKI Clinical Trials for Macular Disease
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 12, 2022, 8:40 a.m. ET

Details of Ocular’s Presentation at Glaucoma360 are as follows:

TITLE: OTX-TIC, An Intracameral Hydrogel-based Travoprost Implant to Treat Patients with Glaucoma and Ocular Hypertension
PRESENTER: Dr. Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer, Ocular Therapeutix
PRESENTATION DATE AND TIME: Saturday, February 11, 2022, 11:39 a.m. ET start of session

“We are pleased to be presenting updated data on both OTX-TKI and on OTX-TIC at these medical meetings,” said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. “OTX-TKI is an intravitreal implant of axitinib delivered via injection, leveraging a new administration and novel mechanism of action for the treatment of patients with wet AMD and other retinal diseases. This latest analysis of interim data from our ongoing Phase 1 trial in Australia in subjects with subretinal and/or intraretinal fluid due to wet AMD continues to support the product’s safety profile and preliminary biological activity signaling a clinically-meaningful decrease in intraretinal and/or subretinal fluid. We are seeing extended duration of activity with over 60% of subjects across all cohorts with a duration of activity of six months or more that could represent a compelling drug product profile.”

Dr. Goldstein continued: “OTX-TIC was developed to deliver travoprost for an extended duration of time to improve the issue of compliance with all topical drop therapies. The Phase 1 data presented highlights OTX-TICs ability to provide a clinically-meaningfully decrease in intraocular pressure comparable to Travoprost for as long as 6+ months with a single implant while preserving corneal health, representing its potential for a unique and differentiated drug product profile. We look forward to dosing our first patient in the Phase 2 trial shortly.”

The presentations being made at these two medical meetings can be accessed February 12th 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 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 other retinal diseases. OTX-TIC (travoprost intracameral implant) recently began a Phase 2 clinical trial for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Ocular Therapeutix has 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 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220211005129/en/

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

Ocular Therapeutix

Scott Corning

Senior Vice President, Commercial

scorning@ocutx.com

Source: Ocular Therapeutix, Inc.

FAQ

What is the purpose of Ocular Therapeutix's OTX-TKI trial for wet AMD?

OTX-TKI is being developed as an axitinib intravitreal implant to treat wet age-related macular degeneration and other retinal diseases.

When will the data for OTX-TKI be presented?

The data for OTX-TKI will be presented at the Angiogenesis Meeting on February 12, 2022.

What type of implant is OTX-TIC and what condition does it target?

OTX-TIC is an intracameral implant of travoprost aimed at treating glaucoma and ocular hypertension.

When is the presentation for OTX-TIC scheduled?

The presentation for OTX-TIC will occur at the Glaucoma360 Meeting on February 11, 2022.

What are the expected next steps for Ocular Therapeutix?

Ocular Therapeutix plans to begin dosing patients in the Phase 2 trial for OTX-TIC shortly.