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Ocular Therapeutix, Inc. - OCUL STOCK NEWS

Welcome to our dedicated page for Ocular Therapeutix news (Ticker: OCUL), a resource for investors and traders seeking the latest updates and insights on Ocular Therapeutix stock.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company dedicated to enhancing vision and quality of life through the development, manufacturing, and commercialization of innovative ocular therapies. The company employs its proprietary hydrogel-based formulation technology to address various diseases and conditions affecting the eye.

The company's lead product, DEXTENZA® (dexamethasone insert), an FDA-approved corticosteroid, is designed for intracanalicular use to treat ocular inflammation and pain following ophthalmic surgery and ocular itching due to allergic conjunctivitis. DEXTENZA delivers dexamethasone to the ocular surface for up to 30 days without preservatives, resorbing naturally, eliminating the need for removal.

Ocular Therapeutix’s pipeline includes several promising candidates. OTX-TIC (travoprost intracameral implant) is in Phase 2 trials for treating open-angle glaucoma and ocular hypertension. Another key candidate is AXPAXLI™ (axitinib intravitreal implant), currently in Phase 3 trials for wet age-related macular degeneration (AMD) and Phase 1 trials for non-proliferative diabetic retinopathy (DR). The company also has OTX-CSI (cyclosporine intracanalicular insert) and OTX-DED (dexamethasone intracanalicular insert) for dry eye disease.

Recently, Ocular Therapeutix announced positive Phase 1 results for AXPAXLI in diabetic retinopathy, accelerating its development to Phase 3. Moreover, recent strategic changes include the appointment of Dr. Pravin U. Dugel as the CEO, aiming to transform the company into a leading retina-focused biopharmaceutical entity.

Ocular Therapeutix has secured significant partnerships and funding to support the clinical development of its robust pipeline. These include a licensing agreement with AffaMed Therapeutics for the commercialization of DEXTENZA in Greater China and ASEAN markets.

Follow Ocular Therapeutix for the latest updates on their innovative pipeline and corporate developments via their website, LinkedIn, and Twitter.

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Ocular Therapeutix announced positive topline results from its Phase 2 clinical trial of OTX-DED, a dexamethasone insert for treating dry eye disease. The trial achieved its primary endpoint, showing significant improvement in bulbar conjunctival hyperemia compared to a vehicle insert, with p-values of 0.004 and 0.028 for the 0.2 mg and 0.3 mg formulations, respectively. The studied insert was well tolerated, with no ocular serious adverse events reported. A conference call to discuss the findings is scheduled for 8:00 a.m. ET.

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Ocular Therapeutix, Inc. (Nasdaq: OCUL) will participate in two upcoming healthcare conferences: the Jefferies London Healthcare Conference on November 18, 2021, with on-demand access to a pre-recorded fireside chat, and the Piper Sandler 33rd Annual Healthcare Conference starting November 22, 2021. Management will have virtual investor meetings available. Interested investors can view the presentations through the company's website.

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Ocular Therapeutix announced that the U.S. Court of Appeals for the Federal Circuit upheld the Patent Trial and Appeal Board's (PTAB) ruling declaring Mati Therapeutics’ patent invalid. This ruling affects the patent related to dexamethasone drug delivery systems, previously claimed to be infringed by Ocular's product, DEXTENZA®. CEO Antony Mattessich expressed satisfaction with the ruling, reinforcing Ocular's commitment to protecting its products. The company holds multiple patents for DEXTENZA, expiring between 2030 and 2040, and continues to believe in the invalidity of any further claims from Mati.

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Ocular Therapeutix reported third-quarter results with net product revenue of $12.2 million, a 107% increase year-over-year. DEXTENZA sales reached $11.9 million, up 120% from Q3 2020. The FDA approved a supplemental NDA for DEXTENZA to treat allergic conjunctivitis, enhancing its market position. Medicare confirmed separate payments for DEXTENZA in outpatient settings through 2022, positioning the product for future growth. However, the Phase 2 trial for OTX-CSI showed no significant efficacy, which may impact investor sentiment.

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Ocular Therapeutix announced that the Centers for Medicare and Medicaid Services (CMS) confirmed separate payment for DEXTENZA in 2022 and beyond, enhancing accessibility for patients. The recent OPPS final rule supports DEXTENZA's eligibility as a non-opioid surgical supply. Additionally, the new Category I CPT Code 68841 for DEXTENZA's insertion establishes standard payments of $37.29 in physician offices and $31.58 in outpatient settings, broadening reimbursement coverage. These developments signify important financial and operational milestones for the company.

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Ocular Therapeutix (NASDAQ:OCUL) announced key scientific presentations at the American Academy of Optometry Annual Meeting 2021 in Boston, MA, from November 3-6. The company highlighted DEXTENZA® for treating ocular inflammation, pain, and itching associated with allergic conjunctivitis. Presentations include analyses of a hydrogel-based dexamethasone insert and comparisons of treatment methods for conditions like keratoconus and dry eye. All presentations will be available on the company’s website starting November 5.

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Ocular Therapeutix, Inc. (NASDAQ: OCUL) will report its third quarter financial results on November 8, 2021, after market close. A live conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a business update. Investors can access the webcast on the company's website or via phone. The company specializes in innovative ocular therapies and is advancing products like DEXTENZA®, while also developing drugs for conditions like wet AMD and glaucoma.

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Ocular Therapeutix (NASDAQ:OCUL) announced multiple scientific presentations at the American Academy of Ophthalmology (AAO) Annual Meeting from November 12-15, 2021. This includes six poster presentations across five indications, highlighting their hydrogel platform pipeline. Key topics include the efficacy of DEXTENZA for allergic conjunctivitis, a Phase 1/2 trial of a cyclosporine insert for dry eye disease, and a travoprost implant for glaucoma therapy. The presentations showcase Ocular's commitment to advancing ophthalmic treatments and improving patient outcomes.

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Ocular Therapeutix (NASDAQ:OCUL) announced topline results from its Phase 2 clinical trial of OTX-CSI, aimed at treating dry eye disease (DED). The study involved 147 subjects over 16 weeks, evaluating the safety and efficacy of two OTX-CSI formulations. Results showed no statistical significance in increased tear production compared to vehicle controls. However, improvements in dry eye symptoms were noted, though not statistically significant. The safety profile was generally favorable with no serious adverse events reported. The company remains focused on future developments including OTX-DED and other pipeline products.

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Ocular Therapeutix has received FDA approval for DEXTENZA, allowing it to treat ocular itching associated with allergic conjunctivitis. This marks the first office-based indication for DEXTENZA, previously approved for postoperative ocular pain and inflammation. DEXTENZA is a physician-administered, preservative-free intracanalicular insert that provides up to 30 days of medication with a single administration. The approval is strategically vital, expanding DEXTENZA’s market potential, as 10 million people in the U.S. seek treatment for allergic conjunctivitis annually.

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FAQ

What is the current stock price of Ocular Therapeutix (OCUL)?

The current stock price of Ocular Therapeutix (OCUL) is $9.089 as of January 7, 2025.

What is the market cap of Ocular Therapeutix (OCUL)?

The market cap of Ocular Therapeutix (OCUL) is approximately 1.4B.

What is Ocular Therapeutix’s main technology platform?

Ocular Therapeutix uses a proprietary hydrogel-based formulation technology for delivering therapeutic agents to the eye.

What is DEXTENZA® used for?

DEXTENZA® is used for treating ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

Which product is Ocular Therapeutix developing for open-angle glaucoma?

Ocular Therapeutix is developing OTX-TIC (travoprost intracameral implant) for the treatment of open-angle glaucoma and ocular hypertension.

What is the status of AXPAXLI™ (OTX-TKI)?

AXPAXLI™ (OTX-TKI) is currently in Phase 3 clinical trials for wet AMD and Phase 1 trials for non-proliferative diabetic retinopathy.

Who is the current CEO of Ocular Therapeutix?

Dr. Pravin U. Dugel is the current President and CEO of Ocular Therapeutix.

What recent partnerships has Ocular Therapeutix secured?

Ocular Therapeutix has a licensing agreement with AffaMed Therapeutics for the commercialization of DEXTENZA in Greater China and ASEAN markets.

What are OTX-CSI and OTX-DED?

OTX-CSI is a cyclosporine intracanalicular insert for the chronic treatment of dry eye disease. OTX-DED is a dexamethasone intracanalicular insert for the short-term treatment of dry eye symptoms.

How long does DEXTENZA deliver medication?

DEXTENZA delivers dexamethasone to the ocular surface for up to 30 days without the need for preservatives or removal.

What clinical trial results were recently announced for AXPAXLI?

Ocular Therapeutix announced positive topline results from the Phase 1 HELIOS study for AXPAXLI in non-proliferative diabetic retinopathy.

What is the focus of Ocular Therapeutix?

Ocular Therapeutix focuses on developing innovative therapies for ocular diseases, including wet AMD, diabetic retinopathy, open-angle glaucoma, and dry eye disease.
Ocular Therapeutix, Inc.

Nasdaq:OCUL

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1.40B
151.33M
1.06%
91.08%
8.13%
Biotechnology
Pharmaceutical Preparations
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United States of America
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