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Ocular Therapeut - OCUL STOCK NEWS

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

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company specializing in the development, manufacturing, and commercialization of innovative therapies for ocular diseases. The company leverages its proprietary ELUTYX™ bioresorbable hydrogel-based formulation technology to address significant unmet needs in eye care, focusing on conditions such as wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and ocular inflammation.

Core Technology and Product Portfolio

Ocular Therapeutix’s innovative platform technology enables the sustained delivery of therapeutic agents directly to the eye, reducing the treatment burden associated with frequent dosing regimens. The company’s flagship commercial product, DEXTENZA®, is an FDA-approved corticosteroid intracanalicular insert for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching due to allergic conjunctivitis. This product exemplifies the company’s commitment to enhancing patient outcomes through sustained-release drug delivery.

Pipeline and Clinical Development

Ocular Therapeutix is advancing a robust pipeline of clinical-stage assets targeting retinal and anterior segment diseases:

  • AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI): A bioresorbable hydrogel implant in Phase 3 clinical trials for wet AMD. AXPAXLI is designed to offer extended durability and reduce the treatment burden of frequent anti-VEGF injections, potentially providing dosing intervals of six to twelve months.
  • PAXTRAVA™ (OTX-TIC): A travoprost intracameral implant in Phase 2 development for open-angle glaucoma or ocular hypertension, aiming to improve intraocular pressure control with sustained drug release.
  • OTX-CSI and OTX-DED: Clinical-stage candidates for the treatment of chronic and short-term dry eye disease, respectively, leveraging the same hydrogel-based technology.

Strategic Focus on Retinal Diseases

With a mission to redefine the retina experience, Ocular Therapeutix is prioritizing the treatment of retinal diseases, particularly wet AMD and diabetic retinopathy. The company’s registrational Phase 3 trials, SOL-1 and SOL-R, are designed to evaluate the safety, efficacy, durability, and repeatability of AXPAXLI. These studies aim to address critical unmet needs in retina care by offering a more sustainable treatment paradigm.

Market Position and Competitive Landscape

Operating in the highly competitive ophthalmology sector, Ocular Therapeutix differentiates itself through its proprietary technology and focus on sustained-release therapies. The company addresses key limitations of current treatments, such as the high frequency of intraocular injections for retinal diseases, which often lead to patient non-compliance and suboptimal outcomes. By targeting both anterior and posterior segment diseases, Ocular Therapeutix positions itself as a versatile player in the ophthalmic therapeutics market.

Commitment to Innovation and Patient Outcomes

Ocular Therapeutix’s expertise in bioresorbable hydrogel technology underpins its ability to develop therapies that enhance patient convenience and adherence. The company’s strategic focus on high-impact therapeutic areas, coupled with its robust clinical pipeline, underscores its commitment to improving vision and quality of life for patients worldwide.

Rhea-AI Summary
Ocular Therapeutix, Inc. announces the initiation of Phase 3 SOL-1 clinical trial for AXPAXLI in wet age-related macular degeneration (AMD). The trial aims to evaluate the efficacy and safety of the treatment, potentially reducing the need for frequent injections and office visits for patients.
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Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that the U.S. FDA has agreed to a Special Protocol Assessment (SPA) Agreement Modification for the Company’s pivotal Phase 3 SOL clinical trial of AXPAXLI™ for the treatment of wet age-related macular degeneration (wet AMD). The amendment expands eligibility criteria, allowing treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better to enroll in the trial. The modification also permits the trial to move forward with a single optimized implant with a drug load of 450 µg of a more soluble form of axitinib, aimed at accelerating the enrollment process and improving drug release synchronization with hydrogel bioresorption.
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Ocular Therapeutix, Inc. (Nasdaq: OCUL) closed a public offering of 35,420,000 shares of its common stock at a price of $3.25 per share, generating approximately $115.1 million in gross proceeds. The company plans to use the net proceeds for the Phase 3 clinical development of AXPAXLI for the treatment of wet AMD and other clinical development programs.
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Ocular Therapeutix™, Inc. (Nasdaq: OCUL) announced the pricing of an underwritten public offering of 30,800,000 shares of its common stock at a public offering price of $3.25 per share for gross proceeds of $100.1 million. The Company has also granted the underwriters a 30-day option to purchase up to an additional 4,620,000 shares. The offering is expected to close soon.
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Ocular Therapeutix, Inc. (OCUL) has commenced an underwritten public offering of its common stock, with an option for underwriters to purchase additional shares. The company plans to use the proceeds to fund the Phase 3 clinical development of AXPAXLI for the treatment of wet AMD and support other clinical development programs.
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Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its participation in upcoming healthcare conferences including Jefferies London Healthcare Conference, BTIG 3rd Annual Ophthalmology Day, and Piper Sandler 35th Annual Healthcare Conference. Management will be available for investor meetings, and live webcasts of the fireside chats will be accessible on the company's website.
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OCUL: FDA agrees to pivotal trial design for AXPAXLI in wet AMD and non-proliferative diabetic retinopathy. Q3 2023 DEXTENZA revenue grows 26% to $15.0 million.
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Ocular Therapeutix, Inc. has received written agreement from the FDA for the design of its Phase 3 clinical trial for AXPAXLI, an intravitreal implant for the treatment of wet age-related macular degeneration (wet AMD). The trial, referred to as the SOL trial, aims to enroll approximately 300 treatment-naïve wet AMD subjects and will be conducted primarily at U.S. sites. The Company expects to dose the first subject by year-end.
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AffaMed Therapeutics announced positive top-line results from a Real-World Study conducted in China evaluating the safety and efficacy of DEXTENZA for the treatment of ocular inflammation and pain following cataract surgery. The trial met its primary and secondary endpoints, demonstrating a significant reduction in inflammation and pain. DEXTENZA was well-tolerated and had a favorable safety profile. AffaMed is developing DEXTENZA to become the first sustained-release intracanalicular insert in China.
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Ocular Therapeutix to report Q3 financial results on November 7, 2023.
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FAQ

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

The current stock price of Ocular Therapeut (OCUL) is $5.925 as of March 3, 2025.

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

The market cap of Ocular Therapeut (OCUL) is approximately 1.0B.

What is Ocular Therapeutix's core technology?

Ocular Therapeutix uses its proprietary ELUTYX™ bioresorbable hydrogel technology to deliver sustained-release therapies for ocular diseases.

What is DEXTENZA®?

DEXTENZA® is an FDA-approved corticosteroid insert for ocular inflammation and pain following ophthalmic surgery, offering sustained drug delivery without the need for removal.

What diseases does AXPAXLI target?

AXPAXLI (OTX-TKI) targets wet age-related macular degeneration (wet AMD) and diabetic retinopathy, aiming to reduce treatment burden with extended dosing intervals.

How does Ocular Therapeutix differentiate itself in the market?

The company focuses on sustained-release drug delivery, reducing the frequency of treatments and addressing compliance issues in retinal and anterior segment diseases.

What is the SOL-1 trial?

The SOL-1 trial is a Phase 3 registrational study evaluating the safety and efficacy of AXPAXLI for wet AMD, with a focus on durability and visual acuity maintenance.

What other products are in Ocular Therapeutix's pipeline?

The pipeline includes PAXTRAVA™ for glaucoma, OTX-CSI and OTX-DED for dry eye disease, and preclinical programs targeting other retinal and anterior segment conditions.

What challenges does Ocular Therapeutix address in retina care?

The company addresses the high treatment burden and patient non-compliance associated with frequent anti-VEGF injections through its sustained-release therapies.

What is the significance of the SOL-R trial?

The SOL-R trial complements SOL-1 by evaluating repeat dosing of AXPAXLI, aiming to provide comprehensive data on durability and treatment flexibility for wet AMD.
Ocular Therapeut

Nasdaq:OCUL

OCUL Rankings

OCUL Stock Data

1.02B
150.15M
1.06%
91.08%
8.13%
Biotechnology
Pharmaceutical Preparations
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United States
BEDFORD