Opthea Announces Publication in Diabetic Macular Edema
MWN-AI** Summary
Opthea Limited (ASX/NASDAQ: OPT), a Melbourne-based biopharmaceutical company, has announced the publication of its Phase 1b clinical trial data on sozinibercept, a novel VEGF-C/D ‘trap’ therapy aimed at treating diabetic macular edema (DME). The findings were published in the peer-reviewed journal *Translational Vision Science & Technology* and featured in its special Anti-VEGF Journal Issue. The study evaluated the combination therapy of sozinibercept with aflibercept in patients who had previously undergone anti-VEGF-A treatment but experienced persistent DME.
The trial included nine patients receiving escalating doses of sozinibercept alongside standard therapy. While the primary focus was on the safety of the treatments, secondary endpoints assessed visual acuity and anatomical parameters. Results demonstrated that sozinibercept combination therapy was well-tolerated with no significant adverse effects. Importantly, a dose-response relationship was observed, with the highest dose (2 mg) achieving notable gains in best-corrected visual acuity (BCVA) and reductions in central subfield thickness (CST), thereby indicating improved anatomical outcomes.
Frederic Guerard, CEO of Opthea, emphasized the potential of sozinibercept to redefine the standard of care in treating retinal diseases such as DME by mitigating retinal blood vessel growth and leakage. As Opthea gears up for the release of topline data from two Phase 3 trials for wet AMD in 2025, the company also plans to advance its clinical program for DME. DME poses a significant challenge, being a leading cause of vision loss among diabetic patients. Opthea’s ongoing research aims to address unmet needs in this expanding patient population, projected to rise from 19 million to 29 million by 2045.
MWN-AI** Analysis
Opthea Limited (ASX/NASDAQ: OPT) recently announced encouraging Phase 1b clinical data on sozinibercept for diabetic macular edema (DME), a promising development for investors in the biopharmaceutical sector. This first-in-class vascular endothelial growth factor-C/D (VEGF-C/D) inhibitor demonstrated a positive safety profile and potential efficacy, as published in the peer-reviewed journal Translational Vision Science & Technology. The publication highlights a significant improvement in visual acuity and anatomical outcomes for patients with DME who previously received anti-VEGF-A monotherapy.
With the upcoming topline data readouts for the COAST and ShORe trials, focused on wet age-related macular degeneration (AMD), anticipated in early CY Q2 2025 and mid-2025 respectively, Opthea is positioning itself for a pivotal moment in its clinical development. The successful outcome of these trials could catalyze investor interest, particularly in light of the pressing need for improved treatment options for retinal diseases with significant unmet medical needs.
DME affects approximately 19 million individuals globally, a figure projected to rise to 29 million by 2045. Current anti-VEGF-A therapies have limitations that sozinibercept aims to address, establishing a strong market opportunity. Given the clinical promise outlined in the Phase 1b results and the substantial patient population affected by DME, investors should consider the potential for Opthea’s stock to appreciate as clinical milestones approach.
Nonetheless, while there is considerable upside potential, investors should remain mindful of inherent risks, including regulatory challenges and competition in the retinal disease space. As such, it may be prudent to maintain a diversified investment strategy while closely monitoring Opthea’s progress and market developments leading into the crucial data readouts.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Phase 1b clinical data underpins sozinibercept’s potential as a novel, first-in-class VEGF-C/D ‘trap’ to improve visual and anatomic outcomes in DME
Published in peer-reviewed journal Translational Vision Science & Technology and included in the Anti-VEGF Special Journal Issue of ARVO
DME program to be advanced after wet AMD topline data readout anticipated for COAST in early CY Q2 2025 and ShORe in mid-2025
MELBOURNE, Australia and PRINCETON, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the publication of its Phase 1b trial of sozinibercept combination therapy in diabetic macular edema (DME) in the peer-reviewed journal Translational Vision Science & Technology (TVST ), issued on December 19, 2024.
The publication, Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema , evaluated the outcomes in previously anti-VEGF-A monotherapy treated patients with persistent DME, a difficult-to-treat patient population. The article was also included in the Anti-VEGF Special Journal Issue of TVST, the official Journal of The Association for Research in Vision and Ophthalmology (ARVO).
“The DME trial results underpin sozinibercept’s potential as a novel, first-in-class VEGF-C/D ‘trap’ to elevate the standard of care in retinal diseases including DME, by preventing blood vessel growth and vascular leakage in the retina and delivering improved visual and anatomic outcomes when combined with standard-of-care anti-VEGF-A therapies,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “Whilst our immediate focus is to prepare for the anticipated sozinibercept Phase 3 topline data readout in wet AMD of COAST in early CY Q2 2025 and ShORe in mid-2025, we also plan to advance our clinical development program of sozinibercept in DME.”
In this first-in-human, open-label, multicenter, dose escalating Phase 1b DME trial, nine patients received sozinibercept (0.3, 1, or 2 mg) in combination with aflibercept (2 mg) once every four weeks for twelve weeks. The primary endpoint was safety, and the secondary endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and anatomical parameters, including central subfield thickness (CST). Sozinibercept combination therapy was well tolerated with no dose-limiting toxicities. The trial also demonstrated a dose-response relationship of increased gains in BCVA for ascending doses of sozinibercept, with the 2 mg sozinibercept combination arm demonstrating the highest BCVA gain. All sozinibercept doses demonstrated a meaningful CST reduction. These data, published in TVST, support the further investigation of sozinibercept as a treatment for DME, a disease with rapidly increasing prevalence and unmet medical need.
Diabetic macular edema is the leading cause of central vision loss in people living with diabetes. It is estimated to affect around 19 million people worldwide, and with the rise of diabetes, the prevalence is expected to increase to 29 million by 2045. DME occurs when blood vessels in the retina swell and leak, leading to fluid accumulation in the retina.
Anti-VEGF-A therapies are the current standard of care for DME patients. There is an unmet need for early intervention to prevent irreversible damage of the retina, as well as improve visual outcomes for patients treated with anti-VEGF-A therapies alone, which may lead to suboptimal vision outcomes.
About Opthea
Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet needs in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea’s lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST, NCT04757636 , and ShORe, NCT04757610 ) for use in combination with standard-of-care anti-VEGF-A therapies to improve the overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents alone.
To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn .
Forward-Looking Statements
This ASX announcement contains certain forward-looking statements, including within the meaning of the US Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding the potential importance of VEGF-C and VEGF-D signaling pathways to the pathogenesis of retinal diseases, sozinibercept’s potential as a novel, first-in-class VEGF-C/D ‘trap’ to improve visual and anatomic outcomes in DME and prevent blood vessel growth and vascular leakage in the retina, sozinibercept’s potential to deliver superior visual outcomes in wet AMD when combined with standard-of-care anti-VEGF-A therapies, the potential for the registrational program for sozinibercept in wet AMD, and the anticipated timing for the results of the COAST and ShORe Phase 3 wet AMD trials and the potential for such results to support a broad label and, if successful, enable sozinibercept to be approved for use in combination with any anti-VEGF-A for the treatment of wet AMD patients and sozinibercept’s clinical development in and potential as a treatment for diabetic macular edema and the expected prevalence of DME. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept’s safety, tolerability and therapeutic efficacy, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law.
Authorized for release to ASX by Frederic Guerard, CEO
| Investor Inquiries PJ Kelleher LifeSci Advisors, LLC Email: pkelleher@lifesciadvisors.com Phone: 617-430-7579 | Media Inquiries Silvana Guerci-Lena NorthStream Global Partners Email: silvana@nsgpllc.com |
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Source: Opthea Limited
FAQ**
How does the Phase clinical data support the hypothesis that sozinibercept can improve visual outcomes in DME patients compared to existing anti-VEGF-A therapies, specifically for Opthea Limited OPT?
What safety and tolerability outcomes from the Phase 1b trial of sozinibercept combination therapy were reported, and how might these results influence future trials for Opthea Limited OPT?
In light of the upcoming topline data readouts from the COAST and ShORe trials in wet AMD, how will Opthea Limited OPT prioritize the advancement of the DME program based on the recent Phase 1b findings?
Considering the rising prevalence of DME, what strategies is Opthea Limited OPT implementing to address the unmet medical needs highlighted by the Phase 1b clinical data?
**MWN-AI FAQ is based on asking OpenAI questions about Opthea Limited (OTC: CKDXF).
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