BEDFORD, Mass., Nov. 13, 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 upcoming presentations at the Jefferies London Healthcare Conference and Ophthalmology Innovation Summit XIV. Jefferies London Healthcare Conference 2024Fireside Chat Date: Wednesday, Nov ...

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 ...

AXPAXLI Clinical Trials & Data - AXPAXLI has demonstrated proof-of-concept in three Phase 1 trials for retinal diseases [2, 130] - In a Phase 1 US trial, 80% of wet AMD patients remained rescue-free per protocol for up to 10 months [5, 134] - Phase 1 Australia Trial showed Monotherapy Activity with CSFT improving from 484µm at baseline to 244µm at Month 9, and BCVA improving from 56 letters (20/80) at baseline to 81 letters (20/25) at Month 9 [3] - HELIOS Phase 1 study in NPDR showed 231% ≥2-step DRSS improvement in AXPAXLI arm at week 48 compared to 0% in sham [261] - In HELIOS Phase 1 study, 0% of patients in the AXPAXLI arm developed PDR or CI-DME at Week 48, compared to 375% in the sham arm [248, 263] SOL-1 Trial - SOL-1 is a multi-center, double-masked, randomized, parallel-group trial with ~150 subjects per group [29, 74] - The primary endpoint of SOL-1 is the proportion of subjects who maintained visual acuity, defined as <15 ETDRS letters of BCVA loss at Week 36 [7, 74] - SOL-1 trial design has been adapted to fit the FDA guidance requirements, including a Special Protocol Assessment (SPA) [48, 50, 143] - Enrollment in the SOL-1 trial has been rapid, with 60 sites activated and 151 subjects enrolled as of May 2024 [91, 99] SOL-R Trial - SOL-R is a Phase 3 wet AMD study designed to demonstrate that AXPAXLI Q6M is non-inferior to fixed-dose aflibercept 2 mg Q8W [114] - The SOL-R trial will enroll 825 total subjects and is being conducted at regulatory risk [114] - SOL-R will capture patients who fail loading or randomization in SOL-1, as well as enroll similar wet AMD patients from other sites [116, 117] Market Opportunity - The estimated US market potential for retinal vascular diseases in 2024 is 92 million, including 165 million for wet AMD, 27 million for moderate-severe NPDR, 14 million for RVO, 17 million for DME, and 17 million for PDR [16]

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 ...

Core Insights - Ocular Therapeutix, Inc. will host an Investor Day on June 13, 2024, focusing on corporate strategy, clinical data, and development plans for AXPAXLI™ in treating wet AMD and NPDR [1][2] - The event will feature presentations from senior company leaders and discussions with key opinion leaders in retinal disease [2][7] - A live webcast of the presentation will be available on the company's website, with a replay accessible for at least 30 days [3] Company Overview - Ocular Therapeutix is a biopharmaceutical company dedicated to developing innovative therapies for eye diseases, including wet AMD and diabetic retinopathy [9] - AXPAXLI™ is a product candidate based on the ELUTYX™ proprietary bioresorbable hydrogel technology, currently in a Phase 3 clinical trial for wet AMD [9] - The company also has other clinical assets, including PAXTRAVA™, which is in a Phase 2 trial for open-angle glaucoma [10] Key Opinion Leaders - Baruch D. Kuppermann, MD, PhD, is a prominent figure in retinal disease research, serving as the Steinert Endowed Professor and Director of the Gavin Herbert Eye Institute at UC Irvine [4][5] - Dilsher S. Dhoot, MD, is a board-certified ophthalmologist with extensive experience in clinical research for retinal diseases [6][8] Clinical Programs - The Investor Day will provide updates on Ocular's clinical program for AXPAXLI in wet AMD, including progress on the ongoing SOL-1 study [7] - An update on Phase 1 HELIOS data for AXPAXLI in non-proliferative diabetic retinopathy (NPDR) will also be discussed [7]