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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 announced the acceptance of a late-breaking abstract related to their Phase 1 HELIOS study for presentation at the 42nd ASRS Annual Scientific Meeting. The study evaluates AXPAXLI, an axitinib intravitreal implant, for non-proliferative diabetic retinopathy (NPDR). The presentation, titled 'Interim Safety and Efficacy Results From the Phase 1 HELIOS Trial of Sustained-release Axitinib Implant (OTX-TKI) for NPDR', is scheduled for July 18, 2024, during the Diabetic Retinopathy Symposium 2 at 10:47 – 10:51 AM CEST. Dr. Dilsher S. Dhoot will present the interim findings emphasizing the potential of AXPAXLI in treating NPDR.
Ocular Therapeutix announced the grant of inducement awards to its newly appointed Director of Statistical Programming, Yong Rao, and three other new employees, under its 2019 Inducement Stock Incentive Plan. The awards comply with Nasdaq Listing Rule 5635(c)(4). Effective July 1, 2024, Mr. Rao received a non-statutory stock option to purchase up to 20,000 shares and a restricted stock unit award for 6,666 shares. The stock options have a ten-year term and vest over four years, while the restricted stock units vest over three years.
Additionally, the three new employees received stock options for up to 38,800 shares and restricted stock unit awards for 12,933 shares. These stock options also have a ten-year term and vest over four years, with the restricted stock units vesting over three years. All awards are contingent on continued service to the company.
Ocular Therapeutix reported significant progress in its AXPAXLI clinical studies and corporate strategy at its recent Investor Day. As of June 7, 2024, 151 subjects have enrolled in the SOL-1 study for wet AMD, with plans for a new repeat dosing study, SOL-R. The SOL-1 study, under an FDA Special Protocol Assessment, aims to compare a single AXPAXLI implant to aflibercept injections. The company disclosed positive 48-week data from the HELIOS NPDR study, showing a ≥2-step DRSS improvement in 23.1% of AXPAXLI-treated patients without vision-threatening complications.
Ocular has also fortified its balance sheet to support operations through 2028 and has strategically streamlined its organization. The company aims to de-risk AXPAXLI’s regulatory pathway and focus on expansive retinal disease markets, confident in the drug's safety and potential best-in-class durability.
Ocular Therapeutix (NASDAQ: OCUL) will host an Investor Day on June 13, 2024, at 2:00 PM ET, both in-person and virtually. The event will feature key opinion leaders Dr. Baruch D. Kuppermann and Dr. Dilsher S. Dhoot, focusing on the company's corporate strategy, clinical data, and development plans for AXPAXLI™. Presentations will include updates on clinical programs for wet AMD and NPDR, specifically the SOL-1 study and Phase 1 HELIOS data. The event will conclude with a Q&A session and a networking reception. A live webcast and a 30-day replay will be available on the company's website.
Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on eye diseases, announced inducement grants for its new Chief Medical Officer, Dr. Nadia K. Waheed, and six other new hires. Dr. Waheed received a non-statutory stock option for 425,000 shares and a restricted stock unit (RSU) award for 141,666 shares, effective June 1, 2024. These options vest over four years and RSUs over three years. Six additional employees received combined stock options for 36,000 shares and RSUs for 12,001 shares, effective June 3, 2024, under the same vesting schedule. The grants are part of Ocular’s 2019 Inducement Stock Incentive Plan, following Nasdaq Listing Rule 5635(c)(4).
Ocular Therapeutix reported its first-quarter 2024 results, highlighting progress towards becoming a leading retinal care company. Recent achievements include leadership appointments, successful financing, and positive Phase 3 program advances. Cash balance of $482.9 million supports operations until 2028. Revenue increased by 10.4% to $14.8 million, driven by DEXTENZA sales. However, net loss widened to $(64.8) million, attributed to higher expenses.
Ocular Therapeutix, Inc. announced inducement awards to new employees, including the Vice President of Programming & Data Operations and the Vice President of Biostatistics. The awards were granted under the Nasdaq Listing Rule 5635(c)(4) as material to the employees' acceptance of employment.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) will be presenting at two upcoming investor conferences in May 2024. The company is dedicated to developing and commercializing innovative therapies for eye diseases like wet AMD and diabetic retinopathy to improve people's vision and quality of life.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) will be presenting at the OIS Retina and ARVO meetings in Seattle, Washington, from May 4-9, 2024. The Company will showcase its innovative therapies for wet age-related macular degeneration and diabetic retinopathy, with multiple presentations scheduled at the events.
Ocular Therapeutix™ announced plans to report first quarter 2024 financial results on May 7, 2024, and host an Investor Day in New York City on June 13, 2024. The event will focus on the company's corporate strategy and retinal disease pipeline.