BEDFORD, Mass., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that the Company will participate in several upcoming investor conferences in March 2026. TD Cowen 46th Annual Health Care Conference:Date: Monday, March 2, 2026Fireside Chat: 9:10 – 9:40 AM ETPresenter: Pravin U. Dugel, MD, Executive Chairman, President and CEOLocation: Boston, MA Jefferies Biotech on the ...

Ocular to present detailed SOL-1 data at the 49th Macula Society Annual Meeting on Friday, February 27, 2026, starting at 1:00 PM PT (4:00 PM ET) Company to host an investor webcast on Monday, March 2, 2026, at 7:30 AM ET to discuss the Macula Society presentations BEDFORD, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that the Company will present detailed re ...

Core Insights - The biotech industry experienced significant developments this week, including FDA approvals, clinical trial results, and licensing agreements, indicating a dynamic landscape for investment opportunities and advancements in healthcare [1]. FDA Approvals & Rejections - NRx Pharmaceuticals is on track for FDA approval of NRX-100, with existing clinical data and real-world evidence from over 65,000 patients potentially supporting a New Drug Application (NDA) under Fast Track Designation [2][3]. - Kane Biotech received FDA clearance for its Revyve Antimicrobial Skin and Wound Cleanser, which targets wound bacteria and biofilms, with plans for manufacturing scale-up in 2026 [4][5]. - Johnson & Johnson's RYBREVANT FASPRO received FDA approval for a simplified monthly dosing schedule, enhancing treatment options for patients with advanced non-small cell lung cancer [6][7]. - Spruce Biosciences reported positive feedback from FDA Type B meetings for its enzyme replacement therapy for Sanfilippo syndrome type B, with a targeted BLA filing in Q4 2026 [8][9]. - Moderna's seasonal influenza vaccine submission (mRNA-1010) is under FDA review, with a PDUFA date set for August 5, 2026, aiming for availability in the 2026/2027 flu season [10][11]. - Disc Medicine received a Complete Response Letter (CRL) for its NDA for Biopertin in erythropoietic protoporphyria, citing insufficient correlation with sunlight exposure endpoints [13][14]. - AbbVie and Genentech's combination regimen of VENCLEXTA and Acalabrutinib for chronic lymphocytic leukemia (CLL) received FDA approval, showing a 35% reduction in disease progression risk compared to standard treatment [15][16]. Deals - Theriva Biologics entered an exclusive licensing agreement with Rasayana Therapeutics for SYN-020, receiving a $3 million upfront payment and potential milestone payments totaling up to $38 million [17][18]. - Sensei Biotherapeutics acquired Faeth Therapeutics, expanding its oncology portfolio with the investigational asset PIKTOR, and announced a concurrent private placement of $200 million to advance clinical milestones [19][20]. Clinical Trials - Breakthroughs - Eli Lilly's Taltz and Zepbound combination therapy showed positive results in a Phase 3 trial for plaque psoriasis and obesity, achieving superior outcomes compared to Taltz alone [21][22]. - Zealand Pharma reported positive Phase 1a results for ZP9830, a Kv1.3 channel blocker, demonstrating safety and tolerability in healthy volunteers [23][24]. - Novartis' Remibrutinib met primary endpoints in a Phase 3 trial for chronic inducible urticaria, showing significant response rates compared to placebo [26][27]. - Ocular Therapeutix's AXPAXLI demonstrated superiority over aflibercept in a Phase 3 trial for wet age-related macular degeneration, although stock prices fell due to investor disappointment [28][29]. - Rallybio's RLYB116 Phase 1 study showed promising results for immune platelet transfusion refractoriness, with plans for a Phase 2 trial in 2026 [31][32]. - Teva and Sanofi's Duvakitug Phase 2b trial demonstrated durable efficacy in ulcerative colitis and Crohn's disease, reinforcing the rationale for ongoing Phase 3 programs [35][36]. - Genentech's Gazyva met primary endpoints in a Phase III study for primary membranous nephropathy, showing significant remission rates compared to tacrolimus [38][39].

Core Viewpoint - Ocular Therapeutix Inc. shares declined following the announcement of Axpaxli treatment data for wet age-related macular degeneration, which did not meet investor expectations [1][2]. Group 1: Trial Results - The SOL-1 Phase 3 superiority trial showed that 74.1% of subjects treated with Axpaxli maintained vision at Week 36, compared to 65.9% in the aflibercept arm, resulting in a risk difference of 17.5% (p=0.0006) [4]. - At Week 52, 65.9% of subjects in the Axpaxli arm maintained vision, compared to 44.2% in the aflibercept arm, with a risk difference of 21.1% [6]. - The trial indicated that 80.6% of subjects in the Axpaxli arm were rescue-free at Week 24, significantly outperforming the aflibercept group [5]. Group 2: Commercial Outlook - The durability advantage of Axpaxli over the active control was smaller than anticipated, raising concerns about its commercial outlook in a market with established therapies [2]. - Ocular Therapeutix plans to submit a New Drug Application (NDA) based on the SOL-1 data, pending discussions with the U.S. FDA [8]. - If approved, Axpaxli could become the first tyrosine kinase inhibitor (TKI) commercialized for wet AMD, potentially holding a superiority label and best-in-disease durability [8]. Group 3: Acquisition Interest - Sanofi SA was reportedly bidding for Ocular Therapeutix, indicating potential interest in the company and its pipeline [7].

Core Viewpoint - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of Ocular Therapeutix, Inc. regarding possible recovery of investor losses under federal securities laws following a significant stock price decline after trial results announcement [1][4]. Group 1: Investigation Details - The investigation focuses on Ocular's executive officers and their compliance with federal securities laws [1][4]. - Ocular announced topline results from its SOL-1 Phase 3 trial on February 17, 2026, revealing that 74% of patients maintained vision at nine months, 66% at twelve months, and approximately 69% were rescue-free at 52 weeks [3]. - Following the announcement, Ocular's stock price declined approximately 27% [3]. Group 2: Law Firm Background - Johnson Fistel, PLLP is a nationally recognized shareholder-rights law firm with multiple offices across the United States, representing both individual and institutional investors [5]. - The firm has been ranked among the Top 10 Plaintiff Law Firms by ISS Securities Class Action Services in 2024, having recovered approximately $90.725 million for clients in cases where it served as lead or co-lead counsel [6].

Core Insights - The conference call was held to discuss the positive topline results from the SOL-1 Phase III clinical trial of AXPAXLI (OTX-TKI) for wet AMD [2][3]. Group 1: Company Overview - Ocular Therapeutix is presenting topline data from its Phase III clinical trial, indicating a significant advancement in its product pipeline [2]. - The call features remarks from key executives and clinical researchers involved in the SOL program, highlighting the collaborative effort in the trial [3]. Group 2: Clinical Trial Details - The SOL-1 trial results are positioned as a pivotal moment for Ocular Therapeutix, potentially impacting the treatment landscape for wet AMD [2]. - The involvement of prominent figures in the ophthalmology field, such as Dr. Arshad Khanani and Dr. Darius Moshfeghi, underscores the credibility and importance of the trial results [3].

Core Insights - The article discusses Ocular Therapeutix and its advancements in diabetic retinopathy and wet AMD treatments, highlighting the company's ongoing research and development efforts [2]. Company Overview - Ocular Therapeutix is focused on developing innovative therapies for eye diseases, particularly diabetic retinopathy and wet age-related macular degeneration (AMD) [2]. Investment Analysis - The author emphasizes the importance of deep-dive analysis in the biotech sector, providing insights into various pharmaceutical companies and their potential for long-term value [2]. - The Biotech Analysis Central service offers a model portfolio of over 10 small and mid-cap stocks, along with extensive analysis and news reports to assist healthcare investors [2].

Company Overview - Ocular Therapeutix is currently advancing its research in diabetic retinopathy and wet age-related macular degeneration (AMD) [2] Analyst Insights - The author of the article, Terry Chrisomalis, has extensive experience in the biotech sector and provides in-depth analysis through the Biotech Analysis Central service [2] - The service includes a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] Subscription Information - The Biotech Analysis Central service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, which represents a 33.50% discount [1]

Market Overview - The US stock market experienced a decline, with the Dow Jones Industrial Average falling 114.78 points to 49,386.15, the S&P 500 dropping 16.85 points to 6,819.32, and the Nasdaq Composite declining 78.52 points to 22,468.15 [1][26] - This decline marks continued weakness, with the Dow and S&P 500 down in four of the past five weeks [1][26] Investor Sentiment - Concerns about artificial intelligence disrupting major industries, falling oil prices following Iran-US nuclear talks, and uncertainty regarding Federal Reserve rate cuts have negatively impacted investor sentiment [2][26] - The earnings season is nearing its end, with significant corporate reports from Walmart, Constellation Energy, Medtronic, and Palo Alto Networks being closely monitored [2][26] AI and Industry Impact - Investors are increasingly questioning how artificial intelligence will reshape various industries, including wealth management, transportation, logistics, and energy [5][26] - The uncertainty surrounding AI has led to profit-taking across technology and growth stocks, contributing to a 0.35% decline in the Nasdaq and a 0.25% loss in the S&P 500 [8][26] Earnings Reports - Constellation Energy's results are being watched for insights into how AI-driven data center demand is affecting electricity consumption [9][26] - Walmart's upcoming quarterly earnings report is critical as it is the company's first update since reaching a trillion-dollar market cap, with investors focusing on consumer spending trends [11][26] Commodity Market - Commodity markets are experiencing heavy selling pressure, with WTI crude oil down 1.05% to $62.23 and Brent crude declining 0.74% to $66.11 [16][27] - The decline in oil prices may ease inflation concerns but also signals potential demand worries [27] Cryptocurrency Market - The cryptocurrency market is also facing declines, with Bitcoin falling 2.19% to $67,326 and the Nasdaq Crypto Index losing 1.91% to 3,255.42, reflecting a broad-based weakness across digital assets [21][27] Economic Indicators - Upcoming economic data, including the Personal Consumption Expenditures (PCE) inflation index and fourth-quarter GDP, could significantly influence market movements [3][22] - A new analysis from Bank of America highlights a "K-shaped economy," where corporate profits are rising while labor income is falling, indicating potential long-term pressures on consumer spending [24][26]

Summary of Ocular Therapeutix SOL-1 Top Line Data Conference Call Company Overview - **Company**: Ocular Therapeutix (NasdaqGM: OCUL) - **Product**: AXPAXLI (OTX-TKI) - **Indication**: Wet Age-related Macular Degeneration (AMD) Key Points from the Conference Call Clinical Trial Results - **SOL-1 Phase 3 Trial**: Positive top-line results announced for AXPAXLI, demonstrating significant efficacy in treating wet AMD [2][4] - **Vision Maintenance**: 74.1% of subjects maintained vision through week 36, with 65.9% maintaining vision through week 52 [5][19] - **Central Subfield Thickness (CSFT)**: 55.9% maintained CSFT within 30 microns of baseline at week 36, and 44.1% at week 52 [5][40] - **Statistical Superiority**: AXPAXLI demonstrated superiority over aflibercept (Eylea) with an 18.3% difference in vision maintenance at week 36 (74.1% vs. 55.8%) and a p-value of 0.0006 [8][11] Mechanism of Action - **Novel Mechanism**: AXPAXLI is the first investigational product in wet AMD with a novel mechanism of action to show superiority to an approved anti-VEGF agent in over 20 years [6][40] Safety Profile - **Well-Tolerated**: AXPAXLI showed a reassuring safety profile with no observed treatment-related ocular or systemic serious adverse events [11][41] - **Durability and Safety**: The combination of durability and safety is expected to facilitate real-world adoption [11][30] Implications for Treatment Paradigm - **Reduced Treatment Burden**: AXPAXLI aims to break the cycle of treatment burden and long-term vision loss, offering a therapy that patients can stay on [7][19] - **Potential for Fixed Dosing**: The ongoing SOLR trial is designed to evaluate fixed six-month dosing, which may yield even better results in a more stable patient population [12][24] Market Positioning - **Immediate Adoption**: If approved, AXPAXLI is expected to be rapidly adopted by retinal specialists due to its safety, durability, and seamless integration into existing workflows [13][30] - **Regulatory Pathway**: Plans to submit an NDA through the accelerated 505(b)(2) pathway, aiming to become the first TKI in the retinal market with a superiority label [39][41] Future Outlook - **Upcoming Presentations**: Detailed results will be shared at the 49th Macular Society Annual Meeting [15][42] - **Long-term Strategy**: A robust patent estate extending into 2044 supports long-term differentiation and sustained value creation [42] Additional Insights - **Rescue-Free Rates**: 80.6% of AXPAXLI-treated subjects were rescue-free at week 24, indicating strong clinical relevance [23][41] - **Clinical Relevance of Data**: The data from SOL-1 provides a clear and clinically intuitive read-through to the ongoing SOLR trial, reinforcing confidence in AXPAXLI's potential [41][42] This summary encapsulates the critical findings and implications from the Ocular Therapeutix conference call regarding AXPAXLI's performance in the SOL-1 trial, highlighting its potential to transform the treatment landscape for wet AMD.