Ocular Therapeutix, Inc. reports news around ophthalmic drug development, commercial product activity and corporate governance for a Nasdaq-listed biopharmaceutical company using ELUTYX proprietary bioresorbable hydrogel formulation technology. Recurring updates focus on AXPAXLI, also known as OTX-TKI, an axitinib intravitreal hydrogel candidate for retinal disease, including wet age-related macular degeneration and diabetic retinal disease such as non-proliferative diabetic retinopathy.
Company announcements also cover DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis, as well as OTX-TIC, a travoprost intracameral hydrogel program for open-angle glaucoma or ocular hypertension. Other recurring items include financial results, scientific and investor conference participation, clinical-study presentations and inducement equity grants under Nasdaq Listing Rule 5635(c)(4).
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.
Ocular Therapeutix has appointed Karen-Leigh Edwards as Senior Vice President of Technical Operations. With over 20 years of experience, she will oversee technical development, manufacturing, and quality operations. Edwards previously held senior roles at Alexion Pharmaceuticals, where she led global manufacturing strategies. The leadership believes her expertise will enhance the growth and value of Ocular's ophthalmic franchise, particularly with products like DEXTENZA and a robust pipeline of therapies nearing late-stage clinical development.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) reported strong sales for its DEXTENZA® billable inserts, with 9,321 units sold in August, marking the second-highest monthly sales figure to date. This follows the sale of 6,924 units in July. The company provides product revenues through authorized specialty distributors selling to medical facilities. Ocular Therapeutix focuses on innovative therapies for eye conditions, with DEXTENZA being its first commercial drug approved by the FDA for post-surgical ocular inflammation and pain. The company anticipates a significant PDUFA action date on October 18, 2021, for an additional indication for DEXTENZA.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The management team will host virtual investor meetings and a pre-recorded presentation will be available starting at 7:00 AM ET on September 13. Ocular Therapeutix focuses on innovative therapies for eye conditions, featuring its FDA-approved drug DEXTENZA®. A supplemental application for DEXTENZA is set for review on October 18, 2021, targeting ocular itching from allergic conjunctivitis.
Ocular Therapeutix (NASDAQ:OCUL) will participate in the H.C. Wainwright Ophthalmology Virtual Conference on August 17, 2021. They will present two panels: Surpassing the Standard of Care for Glaucoma at 7:00 AM ET and Emerging Therapeutics for Dry Eye Disease at 2:00 PM ET. Virtual investor meetings will also be held on the same day. A pre-recorded presentation will be available starting at 7:00 AM ET and can be replayed for 90 days via the company's investor website. The company is advancing innovative ocular therapies, with a PDUFA date of October 18, 2021, for DEXTENZA.