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) is a biopharmaceutical innovator developing sustained-release therapies for retinal diseases and ocular conditions. This page serves as the definitive source for company news, providing investors and professionals with timely updates on clinical advancements, regulatory developments, and corporate milestones.
Access press releases, earnings reports, and analysis of key events impacting OCUL's trajectory. Our curated collection includes updates on AXPAXLI™ clinical trials for wet AMD, DEXTENZA® commercial performance, and pipeline progress across glaucoma and diabetic retinopathy therapies. Discover how the company's proprietary hydrogel platform addresses treatment challenges in ophthalmology.
Bookmark this page for streamlined access to OCUL's latest FDA submissions, partnership announcements, and financial disclosures. Stay informed about developments influencing both near-term performance and long-term growth in ocular therapeutics.
Ocular Therapeutix (Nasdaq: OCUL) announced that the FDA has accepted its supplemental New Drug Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg to treat ocular itching from allergic conjunctivitis. The action date is set for October 18, 2021. If approved, this indication would expand DEXTENZA's use beyond post-surgical inflammation and potentially tap into a market of 10 million patients annually in the U.S. The company emphasizes that DEXTENZA offers a preservative-free method for steroid delivery, addressing significant medical needs.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) has initiated dosing in its Phase 2 clinical trial of OTX-DED, a dexamethasone ophthalmic insert, aimed at treating dry eye disease. This trial will evaluate two formulations in approximately 150 subjects. OTX-DED is designed to offer effective treatment without preservatives that can cause ocular surface toxicities. The dry eye market is valued at around $5 billion globally, presenting significant commercial potential. This study marks a critical step in the company's efforts to address the unmet needs in dry eye management.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) will report its fourth quarter and year-end financial results on March 11, 2021. The management team will hold a live conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update. Ocular Therapeutix is known for developing innovative therapies for eye conditions, including the FDA-approved DEXTENZA for treating post-surgical inflammation and pain. The company is advancing multiple products through clinical trials, including treatments for dry eye disease and retinal diseases.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) will participate in three upcoming conferences. The Cowen 41st Annual Health Care Conference will be on March 1, 2021, with a fireside chat at 12:30 PM ET. The Raymond James 42nd Annual Institutional Investors Conference is set for March 3, 2021, at 9:10 AM ET. The H.C. Wainwright Global Life Sciences Conference occurs on March 9-10, 2021, with a pre-recorded presentation available on March 9 at 7:00 AM ET. Investors can access webcasts and presentations via the company's investor website.
Ocular Therapeutix (NASDAQ: OCUL) announced it will present data from its Phase 1 clinical trial of OTX-TKI, an axitinib intravitreal implant aimed at treating wet AMD, at the Angiogenesis, Exudations, and Degeneration Meeting on February 12-13, 2021. The interim data suggests a favorable safety profile and potential efficacy for OTX-TKI in patients, indicating durability in effects lasting up to six months. Presentation details include time and presenter information, highlighting the significance of the findings for future treatment options in retinal diseases.
Ocular Therapeutix (NASDAQ:OCUL) announced the granting of stock options to a new employee, Dr. Rabia Gurses Ozden, comprising 100,000 shares with time-based vesting and 50,000 shares with performance-based vesting. The options, effective February 1, 2021, have an exercise price of $18.70 per share, matching the closing price on that date. The time-based option vests over four years, while the performance-based option is contingent on achieving specific company milestones. This grant was approved by independent directors as an inducement for Dr. Ozden's employment.
Ocular Therapeutix (NASDAQ: OCUL) announced the presentation of data on OTX-TIC, a travoprost implant for treating primary open-angle glaucoma at the Glaucoma 360 Forum on January 30. Interim Phase 1 trial results showed a mean intraocular pressure reduction of 7-11 mm Hg across cohorts, with durability lasting over six months from a single implant. No serious ocular adverse events were reported, and the hydrogel consistently biodegraded within 5-7 months. The company plans to initiate a Phase 2 trial in mid-2021, emphasizing the potential of OTX-TIC in improving patient compliance with glaucoma treatment.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) has promoted Michael Goldstein, MD, MBA, to President, Ophthalmology, a newly created role where he will oversee clinical and commercial operations. Rabia Gurses Ozden, MD, has been appointed Senior Vice President, Clinical Development, leading the company's growing pipeline. These moves align with the company's strategy to drive growth and innovation in ophthalmic therapies, building upon the success of DEXTENZA, FDA-approved for ocular inflammation treatment. Notably, Ocular is also working on various product candidates in clinical trials.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) announced that underwriters exercised their option to purchase an additional 558,750 shares at $21.50 per share, raising total shares sold to 4,283,750. This resulted in gross proceeds of approximately $92.1 million and net proceeds of around $86.1 million after expenses. The offering, managed by Jefferies LLC and Piper Sandler & Co., was executed under an effective shelf registration statement. Ocular Therapeutix specializes in innovative therapies for eye diseases, with its first product, DEXTENZA®, FDA-approved for treating post-surgery ocular inflammation.
Ocular Therapeutix (NASDAQ:OCUL) has submitted a supplemental New Drug Application (sNDA) to the FDA for DEXTENZA, proposing it for the treatment of ocular itching associated with allergic conjunctivitis. This potential approval could expand DEXTENZA's label for use primarily in ophthalmology offices, appealing to an estimated 10 million patients affected annually. Results from four clinical trials indicate DEXTENZA significantly outperformed placebo in reducing ocular itching. The company expects action on the sNDA by October 2021 under the PDUFA guidelines.