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Ocular Therapeutix™ To Present Clinical Data at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

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BEDFORD, Mass., July 23, 2021--(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 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting being held July 23-27, 2021 in Las Vegas, NV.

"At ASCRS, we will be presenting data on multiple programs we are advancing in the clinic as well as DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use which is commercially available to treat post-operative ocular inflammation and pain and ReSure® Sealant, an FDA-approved device to prevent wound leaks in corneal incisions following cataract surgery," commented Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. "The data being presented continue to support the use of DEXTENZA to treat post-operative ocular inflammation and pain and the ability to research the use of our proprietary hydrogel technology to potentially meet the unmet needs in the ophthalmic space, specifically in glaucoma, dry eye disease and allergic conjunctivitis. As we continue to advance and expand our pipeline, we are pleased with the results we are seeing in both the clinic and surgical settings and continue to evaluate the potential ways to best expand our versatile pipeline."

Ocular Therapeutix Presentations at ASCRS:

DEXTENZA® (Post-operative Ocular Inflammation and Pain):

  • Title: Real World Early Physician Experience Using an Intracanalicular Dexamethasone Insert to Treat Post-Operative Ocular Inflammation and Pain

Session Title: Medications (Preoperative, Postoperative, Intraoperative)

Session Date/Times: Monday, July 26, 2021 at 10:45 AM-10:50 AM PT

Location: MBCR – Level 2, Surf AB

Presenter: John D Stephens, MD

ASCRS Paper ID: 76462

  • Title: Real World Time Savings on Patient Education and Call Backs Related to Post Cataract Therapy Using an Intracanalicular Dexamethasone Insert

Session Title: Medications (Preoperative, Postoperative, Intraoperative)

Session Date/Times: Monday, July 26, 2021 at 10:55 AM-11:00 AM PT

Location: MBCR – Level 2, Surf AB

Presenter: Cynthia Matossian, MD

ASCRS Paper ID: 76483

OTX-DP (dexamethasone ophthalmic insert, 0.4 mg) (Allergic Conjunctivitis):

  • Title: Physician Impressions on Real World Use of Topical Corticosteroids for the Treatment of Allergic Conjunctivitis: Need for a Safer Steroid

Session Title: Ocular Surface II

Session Date/Times: Sunday, July 25, 2021 at 1:40 PM-1:45 PM PT

Location: MBCR – Level 2, Surf AB

Presenter: Lisa Nijm, JD, MD, ABO

ASCRS Paper ID: 76511

  • Title: Pooled Analysis Evaluating Efficacy and Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis

Session Title: Ocular Surface II

Session Date/Times: Sunday, July 25, 2021 at 1:45 PM-1:50 PM PT

Location: MBCR – Level 2, Surf AB

Presenter: Jay M Rubin, MD

ASCRS Paper ID: 76531

Pipeline:

  • Title: Safety and Efficacy of a Novel, Hydrogel-Based Cyclosporine Intracanalicular Insert, for the Treatment of Dry Eye Disease - Phase 1 Study

Session Title: Ocular Surface II

Session Date/Times: Sunday, July 25, 2021 at 1:35 PM-1:40 PM PT

Location: MBCR – Level 2, Surf AB

Presenter: Lee Shettle, DO

ASCRS Paper ID: 76276

  • Title: Evaluating Safety, Tolerability & Efficacy of a Hydrogel-Based Intracameral Travoprost Implant in Glaucoma Patients: Phase 1 Interim Analyses

Session Title: Glaucoma - Medications

Session Date/Times: Sunday, July 25, 2021 at 2:30 PM-2:35 PM PT

Location: MBCR – Level 2, Lagoon F

Presenter: Thomas Walters, MD

ASCRS Paper ID: 76727

ReSure® Sealant:

  • Title: Retrospective Study Comparing the Incidence of Endophthalmitis Following Cataract Surgery in Practices with Access to Hydrogel Sealant

Session Title: Surgical Comparisons

Session Date/Times: Sunday, July 25, 2021 at 8:30 AM-8:35 AM PT

Location: MBCR – Level 2, Surf CD

Presenter: Leon Herndon, MD

Other:

  • Title: Incidence of Endophthalmitis Following Cataract Surgery and Risk Factors: Retrospective Study Using the IRIS Registry

Session Title: Surgical Outcomes

Session Date/Times: Sunday, July 25, 2021 at 8:32 AM-8:37 AM PT

Location: MBCR – Level 2, Surf EF

Presenter: Michael H Goldstein, MD

ASCRS Paper ID: 76786

Investigator-Initiated Trials Presented at ASCRS:

  • Title: The Restore Study: Safety and Efficacy of DEXTENZA for Post-Operative Inflammation and Pain Following PRK

Session Title: Refractive Outcomes

Session Date/Times: Sunday, July 25, 2021 at 8:15 AM-8:20 AM PT

Location: MBCR – Level 2, Surf AB

Presenter: Brian M Shafer, MD

  • Title: Intracanalicular Dexamethasone Insert for Post-Corneal Crosslinking Inflammation and Pain

Session Title: Crosslinking/Corneal Infectious Diseases

Session Date/Times: Sunday, July 25, 2021 at 1:30 PM-1:32 PM PT

Location: MBCR – Level 2, Surf EF

Presenter: Eric D Rosenberg, DO, MSE

  • Title: A Retrospective Analysis of Outcomes Using an Intracanalicular Dexamethasone Implant in Post Cataract and/or Cataract-MIGS Surgery Patients

Session Title: Glaucoma- Medications

Session Date/Times: Sunday, July 25, 2021 at 2:35 PM-2:40 PM PT

Location: MBCR – Level 2, Lagoon F

Presenter: Inder P Singh, MD

  • Title: Immediate Postoperative Versus Next-Day Dexamethasone Intracanalicular Insert for Inflammation and Pain Control Following Cataract Surgery

Session Title: Medications (Preoperative, Postoperative, Intraoperative)

Session Date/Times: Monday, July 26, 2021 at 10:10 AM-10:15 AM PT

Location: MBCR – Level 2, Surf AB

Presenter: Brian B Foster, MD, ABO

  • Title: Postoperative Symptom Control with an Intracanalicular Dexamethasone Insert Compared to Topical Steroid Drops Following Pterygium Surgery

Cornea Posters available On-Demand

Presenter: Haroon Ilyas, MD

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. Ocular Therapeutix has received a target action date under the Prescription Drug User Fee Act, commonly known as PDUFA, of October 18, 2021, for a supplemental new drug application for DEXTENZA to include an additional indication for the treatment of 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. Ocular Therapeutix is currently evaluating each of 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 in Phase 2 clinical trials. Also, in collaboration with Regeneron, OTX-AFS (aflibercept suprachoroidal injection) is in pre-clinical development as an extended-delivery formulation of aflibercept for the treatment of retinal diseases. 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 DEXTENZA for additional indications including the PDUFA target action date scheduled for October 18, 2021 for allergic conjunctivitis, 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, OTX-TKI for the treatment of retinal diseases including wet AMD, and OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept 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 operation of the collaboration with Regeneron Pharmaceuticals and other 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 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 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.

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Contacts

Investors
Ocular Therapeutix
Donald Notman
Chief Financial Officer
dnotman@ocutx.com

or

Westwicke, an ICR Company
Chris Brinzey, 339-970-2843
Managing Director
chris.brinzey@westwicke.com

Media
Ocular Therapeutix
Scott Corning
Senior Vice President, Commercial
scorning@ocutx.com