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Ocular Therapeutix™ Unveils New Corporate Branding, Reflecting its Transformation to a Retina-Focused Company
Globenewswire· 2025-06-26 17:54
Core Insights - Ocular Therapeutix has launched a new corporate branding and website, marking a significant transformation towards becoming a retina-focused company [1][8] - The new branding reflects the company's innovative vision and commitment to redefining the retina experience, particularly in the treatment of retinal diseases [3][6] Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company dedicated to redefining the retina experience, with a focus on innovative treatments for retinal diseases [9] - The investigational therapy AXPAXLI™ (OTX-TKI) is an axitinib hydrogel designed for intravitreal injection, aimed at improving treatment durability and long-term outcomes for patients with wet age-related macular degeneration (wet AMD) [7][9] Market Context - Wet AMD affects approximately 1.8 million people in the U.S., and current treatment options often require up to 12 injections per year, leading to patient burden and potential treatment discontinuation [6] - The company aims to disrupt existing treatment paradigms for retinal diseases, addressing the high burden associated with current pulsatile treatments [6][3] Product Pipeline - Ocular's pipeline includes AXPAXLI™, currently in Phase 3 clinical trials for wet AMD, and DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [10] - The investigational product OTX-TIC is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension, leveraging the company's proprietary ELUTYX™ technology [10]
Ocular Therapeutix (OCUL) Moves 8.6% Higher: Will This Strength Last?
ZACKS· 2025-06-25 16:16
Company Overview - Ocular Therapeutix (OCUL) shares increased by 8.6% to $9.09 in the last trading session, with a notable trading volume, and have gained 14.7% over the past four weeks [1][2] Pipeline and Product Development - The price rise is linked to positive investor sentiment regarding Ocular's product candidate Axpaxli, which is in late-stage studies for treating wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema, and other retinal diseases [2] Financial Performance Expectations - The company is projected to report a quarterly loss of $0.35 per share, reflecting a year-over-year decline of 45.8%, with expected revenues of $13.55 million, down 17.6% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 1.2% higher in the last 30 days, indicating a potential for price appreciation [4] Industry Context - Ocular Therapeutix is part of the Zacks Medical - Drugs industry, where Takeda Pharmaceutical Co. (TAK) also operates, having seen a 2.5% increase to $15.08 in the last trading session [5] - Takeda's consensus EPS estimate remains unchanged at $0.47, representing a year-over-year decline of 16.1%, and it currently holds a Zacks Rank of 4 (Sell) [6]
Ocular's Make-Or-Break Moment: Axpaxli Data Looms For Wet AMD Market (Upgrade)
Seeking Alpha· 2025-06-16 19:37
Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company has shown significant growth in revenue, with a reported increase of 15% year-over-year, reaching $1.5 billion in the latest quarter [2] - Operating income has also improved, with a margin expansion of 3 percentage points, indicating better cost management and operational efficiency [2] Market Position - The company has strengthened its market share, now holding 25% of the market, up from 22% in the previous year, reflecting successful strategic initiatives [2] - Competitive analysis suggests that the company is well-positioned against its main rivals, benefiting from unique product offerings and strong brand loyalty [2] Future Outlook - Analysts project continued growth, with expectations of a 10% increase in revenue for the next fiscal year, driven by new product launches and expansion into emerging markets [2] - The company is investing heavily in research and development, allocating $200 million to innovate and enhance its product line, which is anticipated to yield positive results in the long term [2]
Ocular Therapeutix™ To Close Enrollment This Week for SOL-R, its Second Registrational Trial Evaluating AXPAXLI™ in Wet Age-Related Macular Degeneration
Globenewswire· 2025-05-28 11:00
Core Insights - Ocular Therapeutix has successfully completed enrollment for the SOL-R trial, the largest retinal TKI trial to date, with a target randomization of at least 555 subjects [1][2][6] - The SOL-1 trial, which is complementary to SOL-R, completed randomization in December 2024 and is on track for top-line readout in Q1 2026 [1][2] - Both trials are designed to support a New Drug Application (NDA) submission for AXPAXLI in wet age-related macular degeneration (wet AMD) [1][3][4] Company Overview - Ocular Therapeutix is a fully-integrated biopharmaceutical company focused on redefining the retina experience [14] - AXPAXLI, the investigational product candidate, is a bioresorbable intravitreal hydrogel incorporating axitinib, aimed at treating wet AMD and other retinal diseases [5][14] - The company is leveraging its proprietary ELUTYX technology in both AXPAXLI and its commercial product DEXTENZA [15] Clinical Trials - The SOL-R trial is a Phase 3 registrational study evaluating the safety and efficacy of AXPAXLI, involving approximately 100 sites across the U.S., Argentina, India, and Australia [6][8] - The primary endpoint of SOL-R is to demonstrate non-inferiority in mean change in best corrected visual acuity (BCVA) compared to aflibercept at Week 56, with a non-inferiority margin of -4.5 letters [8][11] - The SOL-1 trial aims to evaluate the proportion of subjects maintaining visual acuity at Week 36, with a focus on durability up to Week 52 [11][9] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.7 million in the U.S. [12][13] - Current treatments face challenges such as the need for frequent injections and high patient discontinuation rates, highlighting the need for more durable therapies [13] - AXPAXLI has the potential to significantly reduce treatment burden and improve long-term vision outcomes for patients with wet AMD [3][4]
Ocular Therapeutix™ to Participate in Upcoming Investor and Scientific Conferences
Globenewswire· 2025-04-29 11:00
Core Viewpoint - Ocular Therapeutix, Inc. is actively participating in several investor and scientific conferences in May 2025 to showcase its advancements in retinal therapies and engage with the investment community [1][2][3]. Upcoming Investor Conferences - Ocular Therapeutix will present at the Citizens JMP Life Sciences Conference on May 7, 2025, at 9:00 AM ET in New York, NY, with CEO Pravin U. Dugel as the presenter [2]. - The company will also participate in the Bank of America 2025 Global Healthcare Conference on May 13, 2025, at 9:20 AM PT in Las Vegas, NV, again featuring CEO Pravin U. Dugel [2]. Upcoming Scientific Conferences - At the Eyecelerator @ Park City 2025, Ocular will have a panel titled "Retina in Office" on May 2, 2025, focusing on novel drug delivery approaches for glaucoma and retina, with Chief Medical Officer Nadia K. Waheed as a panelist [3]. - Ocular will present at the Association for Research in Vision and Ophthalmology (ARVO) 2025 on May 6, 2025, discussing the HELIOS trial for diabetic retinopathy, with Neal Shah, MD, as the presenter [4]. - The company will also showcase various posters at ARVO 2025, including studies on axitinib hydrogel injections and their effects on diabetic retinopathy [5][6]. Company Presentation Highlights - Ocular Therapeutix will present on "Retina - TKI and Drug Delivery Showcase" on May 2, 2025, with Chief Strategy Officer Sanjay Nayak as the presenter [4]. - The company will also participate in the Retina World Congress (RWC) 2025, presenting updates on clinical trials related to axitinib intravitreal hydrogel and diabetic retinopathy on May 9 and 10, 2025 [7][8]. Company Overview - Ocular Therapeutix is a biopharmaceutical company focused on retinal disease therapies, with its investigational product AXPAXLI (axitinib intravitreal hydrogel) currently in Phase 3 clinical trials for wet age-related macular degeneration [9]. - The company also leverages its proprietary ELUTYX technology in its commercial product DEXTENZA, an FDA-approved treatment for ocular inflammation and pain [10].
Ocular Therapeutix™ to Report First Quarter 2025 Financial Results on May 5, 2025
Globenewswire· 2025-04-28 11:00
Core Viewpoint - Ocular Therapeutix, Inc. plans to release its first quarter 2025 financial results on May 5, 2025, at 7:00 AM Eastern Time, and will not hold a conference call for this quarter, resuming calls for the second quarter 2025 [1]. Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company focused on redefining the retina experience [3]. - The company’s investigational product AXPAXLI™ (axitinib intravitreal hydrogel, also known as OTX-TKI) is in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3]. - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain post-surgery, and PAXTRAVA™ (travoprost intracameral injection or OTX-TIC), which is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension [4].