BEDFORD, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL) (“Ocular”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that it plans to host a conference call and webcast on Thursday, November 14, 2024, at 8:00 AM ET to discuss recent business progress and financial results for the third quarter ended September 30, 2024 ...

BEDFORD, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular", the "Company"), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that it will participate in two investor conferences in September: Baird 2024 Global Healthcare Conference Fireside Chat Date: Tuesday, September 10, 2024 Presentation Time: 12:50 PM ET ...

Financial Data and Key Metrics Changes - The company reported approximately $460 million in cash at the end of Q2 2024, providing a cash runway into 2028, which supports ongoing clinical studies [6][12] - The enrollment rate for the SOL-1 study has accelerated and exceeded expectations, indicating strong operational execution [7][14] Business Line Data and Key Metrics Changes - The SOL-1 study is the first of two registration studies for AXPAXLI, focusing on wet AMD, with over 150 patients in various stages of loading and randomization [7][46] - The SOL-R study, which is a repeat dosing study for wet AMD, has been initiated and is designed to complement the SOL-1 study [8][9] Market Data and Key Metrics Changes - The company aims to address the large market size and unmet needs in the treatment of wet AMD, emphasizing the importance of AXPAXLI as a sustainable treatment option [4][5] Company Strategy and Development Direction - The company is transforming into a retina-focused organization, prioritizing the development of AXPAXLI for wet AMD [4][11] - A commitment to financial discipline has led to a reduction in headcount in non-aligned areas, ensuring resources are focused on value-creating activities [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with FDA requirements, which validates the design of the SOL-1 and SOL-R studies [14][22] - The positive initial data from the HELIOS study in non-proliferative diabetic retinopathy (NPDR) is expected to enhance confidence in the success of the ongoing studies [10][33] Other Important Information - The company has achieved significant milestones in a short time, including the activation of 60 sites for the SOL-1 study and the initiation of the SOL-R study within three months [7][8] - The HELIOS study results showed that no patients developed vision-threatening complications after 48 weeks, highlighting the potential of AXPAXLI [10][33] Q&A Session Summary Question: Update on SOL-1 study recruitment timeline - Management indicated that while the previous guidance was for completion in the first half of 2025, the pace of enrollment may allow for earlier completion [18][19] Question: Discussion with EMA regarding SOL studies - Management confirmed ongoing positive discussions with the EMA but did not provide specific updates [18] Question: Clarification on FDA feedback and remaining risks - Management reassured that the FDA's written response aligns with their expectations and mitigates risks regarding study requirements [21][22] Question: Plans for a Special Protocol Assessment (SPA) for SOL-R - Management stated that it is too early to determine if an SPA will be pursued for SOL-R, emphasizing the goal of expediting patient access [24][25] Question: Performance expectations of comparator arms in SOL-R - Management expressed confidence in the selected comparator arms based on historical data and the design of the study [28][30] Question: Enrollment estimates for SOL-R and loading doses - Management clarified that SOL-R will initially recruit patients who screen fail in SOL-1, ensuring it does not cannibalize SOL-1 recruitment [40][42]

SOL-R evaluates repeat AXPAXLI™ dosing for wet age-related macular degeneration (wet AMD) SOL-R is a global, 825-patient, non-inferiority study evaluating repeat dosing of AXPAXLI every six months (Q6M) compared to 2 mg aflibercept, dosed every eight weeks (Q8W) in patients with wet AMD. A third arm evaluating 8 mg aflibercept dosed Q6M is incorporated to ensure the study is adequately masked. The trial is evaluating AXPAXLI versus the current standard of care under the "real world" requirements of a repeat ...

BEDFORD, Mass., July 10, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular", the "Company"), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that a late-breaking abstract related to the Phase 1 HELIOS study of AXPAXLI (axitinib intravitreal imp ...

Mr. Rao's inducement awards were granted effective as of July 1, 2024. Mr. Rao's inducement awards consist of (i) a non-statutory stock option to purchase up to 20,000 shares of the Ocular's common stock at a per share exercise price equal to the closing price of Ocular's common stock on The Nasdaq Global Market on July 1, 2024, and (ii) a restricted stock unit award representing the right to receive 6,666 shares of Ocular's common stock. The stock option has a ten-year term and is scheduled to vest over fo ...

About Ocular Therapeutix, Inc. 151 subjects enrolled in various stages of loading and randomization in SOL-1 pivotal study of AXPAXLI in wet AMD as of June 7, 2024 48-week HELIOS NPDR results show 23.1% of patients in AXPAXLI arm experienced ≥2-step DRSS improvement with no patients experiencing worsening of DRSS or vision threatening complications "2024 has been a time of significant accomplishment for Ocular. To support our mission to become a leader in retinal care, we successfully assembled a 'Retina Dr ...

Ocular's Investor Day will also include KOL roundtable discussions followed by a live Q&A session. In-person attendees are invited to join Ocular leadership and the participating KOLs for a networking reception to conclude the event. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the Company's website at investors.ocutx.com. A replay of the webcast will be archived for at least 30 days following the presentation. About Baruch D. Kuppermann, ...

Shidlovski Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company developing innovative eye treatment therapies. OCUL already offers a commercial product called Dextenza for post-surgical ocular inflammation and pain and ocular itching due to allergic conjunctivitis. The drug is a market success with a net product revenue of $57.9 million in 2023. OCUL's pipeline includes Axpaxli, an axitinib intravitreal implant in phase 3 trials for wet age-related macular degeneration (wet AMD) and phase 1 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36554 Ocular Therapeutix, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...