24/7 Market News- Clearside Biomedical Reports Positive ODYSSEY Phase 2b Trial Topline Results

October 9, 2024

DENVER, Colo., Oct 09, 2024 (247marketnews.com)- Clearside Biomedical (NASDAQ: CLSD) reported that its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD) attained its primary and secondary outcomes.

George Lasezkay, PharmD, JD, Clearside Biomedical’s President and CEO, commented, “These encouraging results strongly support advancing our CLS-AX wet AMD program into Phase 3 development and provide further evidence of the potential benefits of delivering medicines to the back of the eye using our proprietary SCS Microinjector®. We achieved our primary outcome of maintaining stable BCVA throughout the trial as measured by the mean change in BCVA from baseline to Week 36. CLS-AX consistently reduced the frequency of injections after the initial dose of CLS-AX with approximately 90% of CLS-AX participants not requiring any additional treatment up to 4 months, 81% not requiring any additional treatment up to 5 months, and 67% not requiring any additional treatment up to 6 months before mandatory re-dosing at Week 24. We believe this data supports our goal to potentially provide a safe, convenient wet AMD treatment option with the advantage of a flexible maintenance dosing regimen between 3 to 6 months. We look forward to continuing to analyze the results and share additional data analysis with the retina community at upcoming medical meetings.”

Participants who received CLS-AX delivered suprachoroidally maintained stable visual acuity and anatomical control over 9 months, positive safety profile with no ocular or treatment-related serious adverse events, and reduced treatment burden by 84% over 6 months.

Victor Chong, M.D., MBA, Clearside Biomedical’s Chief Medical Officer, stated, “CLS-AX demonstrated extended duration and stable vision and anatomic measures throughout the trial in a difficult-to-treat patient population with reading center confirmed active disease early in their treatment journey. ODYSSEY confirmed the ability to administer multiple doses of CLS-AX from 12 weeks up to 36 weeks with a well-tolerated safety profile. We believe the ability to deliver multiple doses as needed between 12 and 36 weeks is a key differentiator from other treatments in development. In the trial, we observed that CLS-AX, delivered into the suprachoroidal space using our SCS Microinjector®, can be flexibly dosed similar to current biologic treatments, but has the potential to last longer because it is a highly potent tyrosine kinase inhibitor that achieves pan-VEGF blockade. Our goal is to provide a new and important treatment option with meaningful efficacy, safety, and delivery benefits for patients and retina specialists. These topline results provide valuable data in wet AMD with repeat dosing data to better inform our planned Phase 3 program design.”

David M. Brown, M.D., Director of Research, Retina Consultants Houston, added, “These data are encouraging and demonstrate that suprachoroidal CLS-AX may have sustained durability beyond our currently approved agents. The positive safety profile, potential flexible dosing and delivery of CLS-AX directly to the back of the eye via Clearside’s SCS Microinjector has the potential to improve the treatment landscape for patients and physicians looking for a long-acting treatment for wet AMD.”

Clearside Biomedical will host a webcast and conference call today at 8:00 A.M. ET.

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (CLSD)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.