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 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.
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.
Ocular Therapeutix announced a public offering of 3,725,000 shares at $21.50 each, aiming for gross proceeds of approximately $80.1 million. The offering includes a 30-day option for underwriters to buy an additional 558,750 shares. Jefferies LLC and Piper Sandler & Co. lead the underwriting, with the offering closing on or about December 18, 2020, contingent upon standard conditions. The offering is executed under a shelf registration and aims to fund the development of therapies for eye diseases, enhancing its financial position for future growth.
Ocular Therapeutix, Inc. (Nasdaq: OCUL) has initiated an underwritten public offering of $75 million in common stock, with an option for underwriters to purchase an additional $11.25 million. The offering is subject to market conditions and is made under a shelf registration statement that has been filed with the SEC. Jefferies LLC and Piper Sandler & Co. are the joint book-running managers. Investors are advised to review the prospectus for detailed information before making any investment decisions.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) will present at the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. The management team will conduct virtual investor meetings on December 2. A pre-recorded fireside chat presentation is available for streaming on Ocular Therapeutix's investor website, accessible for 90 days. The company focuses on innovative therapies for eye diseases, with FDA-approved DEXTENZA for ocular inflammation and ongoing clinical trials for treatments targeting glaucoma and dry eye disease.
Ocular Therapeutix (NASDAQ:OCUL) announced multiple scientific presentations at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting held from November 13-15, 2020. Highlights include interim Phase 1 data for OTX-TKI, demonstrating safety and biological activity in wet AMD patients. The company also showcased DEXTENZA, emphasizing its efficacy in post-cataract inflammation. Additional studies presented include real-world patient experiences with DEXTENZA, indicating high satisfaction rates. These advancements underline Ocular Therapeutix's commitment to innovative ophthalmic therapies.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced its participation in two upcoming conferences. The Raymond James SMID Cap Company Showcase will take place on November 13, 2020, featuring one-on-one investor meetings. The Jefferies Virtual London Healthcare Conference is set for November 19, 2020, including a fireside chat at 5:35 PM GMT. Interested investors can contact their representatives for meetings, and a live webcast of the fireside chat will be accessible via the company's website. Ocular Therapeutix develops innovative eye therapies using proprietary technology.
Ocular Therapeutix (NASDAQ:OCUL) announced the acceptance of a permanent Category I Current Procedural Terminology (CPT) code for drug-eluting intracanalicular inserts, including DEXTENZA. This change, effective January 1, 2022, replaces the current Category III CPT code, enhancing reimbursement and coverage across payers. The decision validates DEXTENZA's novel administration method and supports other pipeline products. The CPT code aims to standardize payments for the procedure in both ASC and physician office settings, marking a significant milestone for Ocular Therapeutix and its products.