Welcome to our dedicated page for Ocular Therapeutix news (Ticker: OCUL), a resource for investors and traders seeking the latest updates and insights on Ocular Therapeutix 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) has announced inducement awards granted to a new employee under its 2019 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4). The awards, effective January 13, 2025, include:
1. A non-statutory stock option to purchase 95,600 shares at market price, vesting over four years with 25% vesting on January 13, 2026, and the remainder monthly over three years.
2. A restricted stock unit award for 31,375 shares, vesting in equal annual installments over three years, starting January 13, 2026.
Both awards are contingent on continued employment with Ocular through the vesting dates.
Ocular Therapeutix (NASDAQ: OCUL) reported significant progress in its AXPAXLI™ clinical trials for wet age-related macular degeneration (wet AMD) and plans for non-proliferative diabetic retinopathy (NPDR). The company has enrolled 311 subjects in SOL-R, its second registrational trial for wet AMD, while completing randomization for SOL-1, its first registrational trial, with topline data expected in Q4 2025.
The company's wet AMD program consists of two complementary studies: SOL-1, a superiority trial comparing single AXPAXLI injection to aflibercept, and SOL-R, a non-inferiority trial evaluating repeat AXPAXLI injections. Both trials are designed to support a potential New Drug Application.
Following positive results from the Phase 1 HELIOS trial for NPDR, where no patients developed vision-threatening complications after 48 weeks with a single AXPAXLI injection, Ocular plans to seek FDA feedback on clinical trial design in H1 2025.
Ocular Therapeutix (NASDAQ: OCUL) announced its upcoming presentation at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 5:15 PM PT in San Francisco. Pravin U. Dugel, MD, the company's Executive Chairman, President and CEO, will provide updates on several key areas including:
- The enrollment status of SOL-R, their second registrational trial of AXPAXLI™ for treating wet age-related macular degeneration (wet AMD)
- Future opportunities for AXPAXLI
- A general corporate overview and strategic outlook for 2025
The presentation will be accessible through the Events and Presentations section of the company's Investor Relations webpage.
Ocular Therapeutix (NASDAQ:OCUL) has announced inducement awards for a new employee under its 2019 Inducement Stock Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4). The awards, effective December 9, 2024, include:
- Non-statutory stock options to purchase 215,000 shares at market price, vesting over 4 years with 25% after first year and remaining monthly over 3 years
- Restricted stock unit awards for 70,000 shares, vesting in equal annual installments over 3 years starting December 9, 2024
Both awards are contingent on continued employment with the company.
Ocular Therapeutix (NASDAQ: OCUL) has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The conference will take place from January 13-16, 2025, in San Francisco, CA. Dr. Pravin U. Dugel, Executive Chairman, President and CEO, will deliver the company's presentation on Monday, January 13, 2025, at 5:15 PM PT.
The presentation will be accessible through a live webcast on the Events and Presentations section of the company's Investor Relations webpage. Ocular Therapeutix is a biopharmaceutical company focused on developing and commercializing innovative therapies for retinal diseases and other eye conditions, with the mission of improving real-world vision.
Ocular Therapeutix (NASDAQ: OCUL) has announced significant progress in its Phase 3 clinical trials for AXPAXLI™ in wet AMD treatment. The company has successfully randomized over 300 patients in its first registrational trial, SOL-1, which is expected to close randomization this week. Topline data from SOL-1 is anticipated in Q4 2025. The company's second registrational trial, SOL-R, is now accepting direct patient enrollment at active clinical sites, accelerating recruitment pace. Both trials are designed to evaluate AXPAXLI's potential as a durable treatment option that could be dosed every six to nine months for wet AMD patients.
Ocular Therapeutix (NASDAQ: OCUL) has announced its participation in key December investor and scientific conferences. The company will present at the Piper Sandler 36th Annual Healthcare Conference with a fireside chat on December 3rd, 2024, featuring CEO Pravin U. Dugel. Additionally, the company will have a significant presence at FLORetina ICOOR 2024 in Florence, Italy, with multiple presentations scheduled between December 5-7, 2024.
The presentations will focus on their OTX-TKI treatment, including 48-week results from the HELIOS Phase I Trial for non-proliferative diabetic retinopathy, and discussions on TKIs in retinal disease management. Multiple sessions will feature presentations by leading medical experts including Dr. Dilsher S. Dhoot and Dr. Diana V. Do.
Ocular Therapeutix (NASDAQ: OCUL) reported Q3 2024 financial results and business updates. The company achieved total net revenue of $15.4 million, a 2.3% increase from Q3 2023. Cash position stands at $427.2 million, expected to fund operations into 2028. The Phase 3 SOL-1 trial for AXPAXLI in wet AMD is expected to complete randomization by year-end 2024, with topline data anticipated in Q4 2025. The company reported a net loss of $36.5 million or $(0.22) per share. Full-year 2024 DEXTENZA revenue guidance is projected between $62.0-67.0 million.
Ocular Therapeutix (NASDAQ: OCUL) has announced its participation in two major healthcare events. The company will present at the Jefferies London Healthcare Conference on November 20, 2024, featuring a fireside chat at 9:00 AM GMT, which will be accessible via webcast on the company's investor website.
Additionally, the company will participate in the Ophthalmology Innovation Summit XIV in San Diego on November 22-23, 2024. The event will feature three sessions: a Retina Innovation Showcase presented by Chief Strategy Officer Sanjay Nayak, a Glaucoma Spotlight panel featuring Board Member Adrienne Graves, and 'A View From The Street' panel moderated by CEO Pravin U. Dugel.
Ocular Therapeutix (NASDAQ: OCUL) has appointed Namrata Saroj, OD, as Chief Business Officer (CBO). Dr. Saroj, who previously served as Development Strategy Consultant since February 2024, brings over 20 years of experience in ophthalmic drug development and commercialization. She has contributed to successful FDA-approved drugs including LUCENTIS® and EYLEA®, and has been instrumental in executing Ocular's registrational program for AXPAXLI™ in wet age-related macular degeneration. Dr. Saroj's expertise spans clinical development, trial enrollment, launch preparation, and commercialization support across various stages of pharmaceutical development.
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