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 American Academy of Ophthalmology (AAO) 2021 Annual Meeting being held November 12 -15, 2021.
“We are happy to have a large presence at AAO this year with six poster presentations in five different indications,” said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. “The presentations continue to highlight the depth of our pipeline being developed with our novel hydrogel platform. We are excited to be providing data updates on a number of these programs.”
ePosters (On-Demand from Nov 12):
Efficacy and Safety of an Intracanalicular Dexamethasone Insert (0.4 mg) for the Treatment of Allergic Conjunctivitis. S Silverstein (PO172)
A pooled analysis of randomized, controlled clinical trials assessing efficacy (three Phase 3 clinical trials) and safety (one Phase 2 and three Phase 3 clinical trials) demonstrated DEXTENZA was superior to vehicle insert for treating ocular itching due to allergic conjunctivitis. DEXTENZA had a favorable safety profile and was generally well tolerated with a low rate of adverse events.
Phase 1/2 Trial Evaluating a Novel, Hydrogel-based Cyclosporine Intracanalicular Insert in Subjects with Dry Eye Disease. W Christie (PO170)
The poster includes a recap of the Phase 1 clinical trial to assess the safety, tolerability, and biological activity of cyclosporine intracanalicular insert (OTX-CSI) in subjects with dry eye disease. The poster also includes the top-line results from the Phase 2 clinical trial, including the data for the primary endpoint of increased tear production at 12 weeks as measured by the Schirmer’s Test; baseline characteristics of the subject population; and retention data showing lower than anticipated insert retention rates in the active drug groups.
Hydrogel-based, Sustained-release Intracameral Travoprost Implant for Glaucoma Therapy: A Phase 1 Clinical Trial. D. Goldberg (PO212)
Phase 1 clinical trial assessing the safety and biological activity of a single intracameral travoprost implant (OTX-TIC) in glaucoma or ocular hypertension subjects showed a reduction in IOP as least as good as topical travoprost with durations of 6+ months (Cohorts 1&2) and 3-6 months (Cohorts 3&4), consistent hydrogel resorption and a favorable safety profile.
Phase 1 Trial of a Novel, Hydrogel-based, Intravitreal Axitinib Implant for the Treatment of Neovascular Age-related Macular Degeneration. A Moshfeghi (PO323)
An interim data update of the ongoing Phase 1 Australia-based clinical trial assessing the safety and biological activity of an intravitreal axitinib implant (OTX-TKI) in subjects with wet age-related macular degeneration (wAMD). To date, OTX-TKI has been generally well tolerated and showed preliminary biological signals of durability and meaningful decrease in retinal thickness.
Poster Theatre Presentations
A Contemporary Retrospective Analysis of Endophthalmitis Following Cataract Surgery Using the IRIS Registry.M Goldstein (PO020, Saturday, Nov 13 3:45 – 3.51 PM)
A retrospective analysis using AAO’s IRIS Registry was used to determine the incidence of and risk factors for endophthalmitis after cataract surgery. The analysis reviewed 6.7 million eyes in 4.1 million patients and identified risk factors for endophthalmitis after cataract surgery from 2016-19 to help identify high risk patients.
Real-World Evidence of an Intracanalicular Dexamethasone Insert Saving Time on Patient Education and Calls for Post-Cataract Surgery Care. L Nijm (PO021, Saturday, Nov 13 3:55 - 4:01 PM)
Data from a real-world study evaluating the impact of using an intracanalicular dexamethasone insert (DEXTENZA®) on physicians’ practices showed that replacing the complex post-cataract surgery steroid eye drop regimen with physician-administered DEXTENZA saved practices in the study approximately 40 hours each week typically spent on patient education and call backs.
All virtual presentations will be available for those registered starting November 12, 2021, by accessing the American Academy of Ophthalmology’s 2021 Mobile Media Guide. ePosters will be available as of November 12th on the Company’s website (www.ocutx.com, under the Investors tab).
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 currently in Phase 1 clinical trials include OTX-TKI (axitinib intravitreal implant) for the treatment of wet AMD and other retinal diseases and OTX-TIC (travoprost intracameral implant) for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. In addition to OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease, Ocular Therapeutix is currently evaluating OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease in Phase 2 clinical trials. 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 effectiveness of 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, availability of data from clinical trials and expectations for regulatory submissions and approvals, the interpretation of data from the Company’s clinical trials, including interim data such as the data referred to above which may not be indicative of the full data from a trial, 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 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.