Ocular Therapeutix™ To Present Pre-Clinical and Clinical Data at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
Ocular Therapeutix (NASDAQ:OCUL) announced its participation in the ARVO Annual Meeting featuring presentations on key programs, notably OTX-TKI for wet AMD and OTX-TIC for glaucoma, with advances towards Phase 2 clinical trials. Presentations include safety studies of corticosteroids post-cataract surgery and pharmacokinetics of various hydrogel-based implants. The FDA has set a PDUFA date of October 18, 2021, for DEXTENZA to treat allergic conjunctivitis, enhancing its market potential. The company's hydrogel technology aims to provide innovative treatments for eye diseases.
- Advancement of OTX-TKI and OTX-TIC towards Phase 2 clinical trials.
- PDUFA target action date for DEXTENZA regarding allergic conjunctivitis on October 18, 2021.
- None.
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. With the ARVO 2021 Annual Meeting being moved to a virtual format, video-recorded presentations are scheduled to become available online at ARVOLearn on May 1, 2021.
“We are pleased to be presenting data on our pre-clinical and clinical programs at this year’s annual meeting, including updated data on two of our key programs, OTX-TKI for the treatment of wet AMD and OTX-TIC for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension,” commented Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer of Ocular Therapeutix. “The progress we are making in these two programs is exciting as we look to advance each into Phase 2 clinical trials. Our hydrogel platform continues to offer patients and physicians a potential novel, hands-free option to address both front and back-of-the-eye diseases. We look forward to the continued progress of these programs while we continue expanding the capabilities of our diverse platform.”
Presentations at ARVO:
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Title: Safety and Efficacy of Topical, Transzonular, and Intracanalicular Corticosteroids for the Prevention of Postoperative Inflammation after Cataract Surgery
Session Title: Cataract Surgery/Epidemiology
Session Date/Times: May 2, 2021 from 11:15 AM to 1:00 PM EDT
Presenter: Dr. Amy Lu
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Title: Phase 1 Study of an Intracameral Travoprost Hydrogel-based Implant for the Treatment of POAG and Ocular Hypertension
Session Title: Pharmacological intervention and cellular mechanisms
Session Date/Times: May 3, 2021 from 11:15 AM to 1:00 PM EDT
Presenter: Dr. Damien Goldberg
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Title: Incidence of Endophthalmitis Following Routine or Complex Cataract Surgery in Practices With and Without Access to Hydrogel Sealant: Retrospective Study Using the IRIS Registry
Session Title: Healthcare Delivery and Quality of Care
Session Date/Times: May 5, 2021 from 9:00 AM to 10:45 AM EDT
Presenter: Dr. Michael H Goldstein
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Title: Phase 1 Study of an Intravitreal Axitinib Hydrogel-based Implant for the Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
Session Title: AMD and retinal physiology
Session Date/Times: May 5, 2021 from 2:45 PM to 4:30 PM EDT
Presenter: Dr. James Wong
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Title: Ocular Pharmacokinetics of OTX-DED, a Sustained-release Intracanalicular Insert Delivering Dexamethasone, in a Canine Model
Session Title: Dry Eye and Tear film
Session Date/Times: May 5, 2021 from 2:45 PM to 4:30 PM EDT
Presenter: Charles Blizzard
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Title: Pharmacokinetics of OTX-CSI, a Cyclosporine Intracanalicular Insert, in Surgically Induced Dry Eye Beagle Dogs
Session Title: Cornea, cytokines, anti-inflammatory
Session Date/Times: May 7, 2021 from 2:15 PM to 4:00 PM EDT
Presenter: Andrew Vanslette
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Title: Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis: Pooled Post-hoc Analysis of Four Studies
Session Title: Cornea, cytokines, anti-inflammatory
Session Date/Times: May 7, 2021 from 2:15 PM to 4:00 PM EDT
Presenter: Dr. John Meyer
The online presentations are expected to be hosted in the Media library catalog within ARVOLearn.
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 FDA-approved 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 to include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of DEXTENZA. 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 presentations at medical, scientific or industry conferences; 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 DEXTENZA; 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, including any potential future payments thereunder; projected net product revenue, unit sales and other financial and operational metrics of DEXTENZA; 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 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 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 unit 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 or other actions 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 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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