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.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) generates frequent news as an ophthalmology-focused biopharmaceutical company advancing late-stage retinal programs and a commercial eye-care product. Its press releases highlight progress across the AXPAXLI (OTX-TKI) clinical programs in wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR), as well as updates related to DEXTENZA, financings, and corporate events.
News coverage for OCUL commonly includes clinical milestones such as target randomization in the SOL-R Phase 3 wet AMD trial, completion of randomization in SOL-1, and the initiation or advancement of the HELIOS Phase 3 registrational program in NPDR. The company also issues announcements about regulatory strategy, including Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration for SOL-1 and HELIOS-2 and plans to leverage the 505(b)(2) pathway for AXPAXLI in wet AMD.
Investors following OCUL news will see regular business and capital markets updates, such as underwritten equity offerings, cash runway disclosures, and inducement equity grants under Nasdaq Listing Rule 5635(c)(4). The company also reports quarterly financial results and business highlights, describing clinical execution, trial timelines, and planned extension studies like SOL-X for long-term evaluation of AXPAXLI in wet AMD.
In addition, Ocular Therapeutix announces participation in scientific and investor conferences, where it presents data from earlier-stage trials (for example, HELIOS Phase 1 results in NPDR) and discusses its strategy to "redefine the retina experience." For a consolidated view of these developments, the OCUL news page on Stock Titan brings together clinical, regulatory, financial, and corporate communications so readers can track how trial outcomes, regulatory interactions, and financing activities may shape the company’s ophthalmic pipeline and commercial portfolio over time.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.