Ocular Therapeut Stock Price, News & Analysis

Ocular Therapeutix (NASDAQ: OCUL) has initiated patient enrollment in the Phase 3 SOL-R clinical trial for AXPAXLI™, evaluating its efficacy in treating wet age-related macular degeneration (wet AMD). This global study involves 825 patients and aims to demonstrate non-inferiority of AXPAXLI dosed every six months compared to 2 mg aflibercept dosed every eight weeks. The trial includes a third arm with 8 mg aflibercept dosed every six months for masking purposes.

SOL-R complements the ongoing SOL-1 trial, focusing on repeat dosing to reflect real-world treatment scenarios. It will initially enroll patients ineligible for SOL-1, later expanding to include treatment-naïve patients or those recently diagnosed with wet AMD. The study design incorporates multiple aflibercept loading doses and evaluates patients to limit retinal fluid fluctuations, potentially increasing the likelihood of success.

Ocular Therapeutix (NASDAQ:OCUL), a biopharmaceutical company focused on developing therapies for eye diseases, has announced inducement awards for its new Senior Vice President and Chief of Staff, Chad Clatterbaugh. The awards, granted under Ocular's 2019 Inducement Stock Incentive Plan, include:

1. A non-statutory stock option to purchase 110,000 shares of Ocular's common stock, vesting over four years.

2. A restricted stock unit award for 36,666 shares, vesting over three years.

These awards are designed to incentivize Mr. Clatterbaugh's employment and are subject to his continued service with Ocular. The grants comply with Nasdaq Listing Rule 5635(c)(4) and were effective as of July 12, 2024.

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.