Latest news with #CLS-AX
Business Insider
18-07-2025
- Business
- Business Insider
Clearside Biomedical downgraded to Hold from Buy at Stifel
Stifel downgraded Clearside Biomedical (CLSD) to Hold from Buy with a price target of $2, down from $8. In a challenging financing environment, Clearside has arrived at the end of its cash runway with no new injection of capital and is now considering strategic alternatives, the analyst tells investors in a research note. The firm added that, given the company has been seeking capital influx for some time for further development of CLS-AX, the outcome of its new efforts to preserve cash and maximize the remaining value in its platform is uncertain. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Business Upturn
17-07-2025
- Business
- Business Upturn
Clearside Biomedical Announces Plan to Explore Strategic Alternatives to Advance its Proprietary Suprachoroidal Space (SCS®) Delivery Platform and Promising Ophthalmology Pipeline
– Proven In-Office, Repeatable, Non-Surgical Procedure for the Targeted Delivery of a Wide Variety of Therapies for Serious Retinal Diseases – – CLS-AX Phase 3-Ready Asset with Global Investigator Support and FDA Alignment on Pivotal Trial Program in wet AMD – – Validated Delivery Platform with Five Commercial and Late-Stage Development Suprachoroidal Licensing Collaborations – ALPHARETTA, Ga., July 17, 2025 (GLOBE NEWSWIRE) — Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today announced plans to explore a full range of strategic alternatives to advance its SCS platform and drug development pipeline to maximize stockholder value. The Company has retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support it with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of the Company's assets and technologies, collaboration, partnership, merger, acquisition, joint ventures, or other strategic transactions. 'We strongly believe that our proprietary suprachoroidal delivery platform provides an effective and reliable way to target challenging retinal diseases that need longer lasting treatments,' said George Lasezkay, PharmD, JD, President and Chief Executive Officer. 'Our SCS Microinjector® enables a proven in-office, repeatable, non-surgical procedure for the targeted delivery of a wide variety of therapies to the macula, retina, and choroid. Based on our retinal expertise and intellectual property, we delivered the first commercial product using our SCS platform, which is now approved and commercialized in the U.S., approved in Singapore and Australia, and is currently under regulatory review in China and Canada.' Dr. Lasezkay further stated, 'We have successfully produced positive and highly competitive Phase 2b clinical data for CLS-AX for the treatment of wet AMD. We are proud of the fact that the CLS-AX ODYSSEY Phase 2b trial is the only TKI clinical trial to date to achieve positive safety and efficacy results from multiple TKI dosing in wet AMD patients. Further, in February 2025, we conducted a successful end of Phase 2 meeting with the FDA through which we gained alignment on a Phase 3 development plan for CLS-AX in wet AMD. In addition, our clinical development collaboration partners continue to make progress in advancing their later-stage suprachoroidal clinical programs utilizing our SCS Microinjector in various ophthalmic disorders.' Dr. Lasezkay continued, 'Clearside's innovative and pioneering achievements demonstrating the safety, simplicity and effectiveness of delivering drugs to the suprachoroidal space are the direct result of the many years of significant contributions by the current Clearside team and many of our past employees. I am proud of and grateful for their hard work and dedicated commitment to improving the lives of patients suffering from the burden of disabling, blinding diseases.' 'Given the current unpredictable economic environment and challenging fundraising conditions in the biopharmaceutical industry, we are taking the necessary next steps to evaluate strategic alternatives for the Company. In order to facilitate this process and conserve cash, while continuing our support of the Company's SCS Microinjector® licensees, all Clearside employees, including the Chief Executive Officer, Chief Financial Officer, and Chief Medical Officer, will transition into consulting roles with the Company this week. In addition, we will pause all internal research and development programs during this process,' concluded Dr. Lasezkay. No agreement providing for any strategic transaction has been reached and there can be no assurance that this process will result in any such transaction. Clearside has not set a timetable for the strategic review process. Clearside does not intend to provide updates until the Board approves a specific action or otherwise determines that disclosure is appropriate or required. Company Highlights SCS Injection Platform: The SCS Microinjector is a proven in-office, repeatable, non-surgical procedure for the targeted delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside has formulation expertise in developing small molecule suspensions that can be delivered into the suprachoroidal space, and commercial scale manufacturing capability for the SCS Microinjector that includes ISO certification. The Company successfully navigated the U.S. Food & Drug Administration (FDA) drug/device regulatory pathway to obtain commercial approval for its first product, XIPERE ® (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of uveitic macular edema. (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of uveitic macular edema. A permanent CPT code is assigned in the U.S. for suprachoroidal injections permitting physicians to receive higher reimbursement for administering any drug into the SCS versus the reimbursement of the current practice of injecting drugs into the vitreous. Internal Pipeline – CLS-AX Program: CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. CLS-AX is being developed for the treatment of neovascular age-related macular degeneration (wet AMD). Axitinib is a tyrosine kinase inhibitor (TKI) that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Age-related macular degeneration causes a progressive loss of central vision and is the most common cause of legal blindness in individuals over age 55. Wet AMD is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision, and accounts for the majority of vision loss in patients with this disorder. Suprachoroidal injection of CLS-AX has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials. These data strongly support the potential efficacy, safety and versatility of CLS-AX to treat this chronic disease. Clearside conducted a successful End-of-Phase 2 meeting with the FDA and aligned on the essential components of a Phase 3 program. The Phase 3 program is designed to maximize the commercial potential for CLS-AX with the potential to provide physicians and their patients with dosing flexibility similar to the current standard of care anti-VEGF biologics, but with the extended durability of a TKI. This combination of dosing flexibility and durability may improve outcomes and reduce the treatment burden for patients suffering from these potentially blinding retinal disorders, as well as their caregivers. Internal Pipeline – Preclinical Small Molecule Programs: Clearside is evaluating various small molecules for a range of retinal diseases with high unmet medical need. Clearside is evaluating preclinical data on two approaches targeting Geographic Atrophy (GA) – improving choroidal perfusion and modulating pro-inflammatory cells. GA is a progressive, late-stage form of dry age-related macular degeneration characterized by well-defined areas of retinal cell loss in the macula, leading to irreversible central vision impairment. Delivery of small molecules via suprachoroidal injection enables comprehensive drug coverage of both the retina and choroid, while also potentially minimizing systemic and anterior segment side effects. Clearside is evaluating preclinical data on the combination of a steroid plus a TKI (axitinib formulation) for the treatment of Diabetic Macula Edema (DME). DME is the most common cause of vision loss in individuals with diabetes, in which fluid accumulates in the central part of the retina causing swelling and vision distortion due to leaky blood vessels damaged by prolonged high blood sugar. External Licensing Agreements: Clearside strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic agents including gene therapies and anti-tumor agents. Clearside's innovative SCS Microinjector is being used in commercial ophthalmic products and promising clinical development programs by Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen. About Clearside Biomedical, Inc. Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside's SCS injection platform, utilizing the Company's patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company's lead program, CLS-AX (axitinib injectable suspension), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit or follow us on LinkedIn and X. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'believe', 'expect', 'may', 'plan', 'potential', 'will', and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, including the planned Phase 3 trial design, the potential benefits of CLS-AX, Clearside's suprachoroidal delivery technology and Clearside's SCS Microinjector®, and Clearside's pursuit of strategic alternatives and the entry into or completion of any strategic alternative transaction. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control, Clearside's ability to raise additional capital, and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 27, 2025 and Clearside's other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contacts: Jenny Kobin Remy Bernarda [email protected]
Associated Press
10-02-2025
- Business
- Associated Press
Clearside Biomedical Announces Additional Data from the CLS-AX ODYSSEY Phase 2b Trial Presented at the Angiogenesis, Exudation, and Degeneration 2025 Meeting
ALPHARETTA, Ga., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) ('Clearside' or the 'Company'), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that two subgroup analyses were presented from the ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting. ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week trial evaluating CLS-AX (axitinib injectable suspension) in participants with neovascular age-related macular degeneration (wet AMD). The presentation, entitled 'Phase 2b CLS-AX ODYSSEY Trial Results', was presented by Roger Goldberg, MD, MBA, Bay Area Retinal Associates Medical Group. Dr. Goldberg reviewed key data from ODYSSEY, including two sub-group analyses that guided the design of the planned CLS-AX Phase 3 clinical development program. The presentation also described the differentiated combination of CLS-AX, a highly potent, selective pan-VEGF tyrosine kinase inhibitor (TKI), delivered by suprachoroidal injection utilizing Clearside's proprietary SCS Microinjector®. Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, 'The analyses presented at Angiogenesis highlight how CLS-AX can provide a durable treatment in wet AMD while maintaining visual acuity. The subgroup data from our ODYSSEY Phase 2b trial provided us with key clinical insights that contributed to the design of our planned CLS-AX Phase 3 non-inferiority clinical trials. These results support our plan to enroll a general population of treatment-naïve participants and potentially reduce non-disease related variability in visual acuity at randomization to better ensure the CLS-AX Phase 3 data can be translated to real-world treatment practices.' The first sub-group analysis supports enrolling treatment naïve patients in the planned CLS-AX Phase 3 program. The analysis showed stabilization of both the best corrected visual acuity (BCVA) and central subfield thickness (CST) in participants re-dosed with CLS-AX at Week 24 who did not require aflibercept rescue or CLS-AX re-dosing prior to Week 24. In ODYSSEY where the participants were intentionally screened to meet more difficult to treat criteria, 67% of those participants in the CLS-AX arm did not require aflibercept rescue or CLS-AX re-dosing for 6 months. By targeting the more general wet AMD population in the planned Phase 3 trial, there may be an even greater percentage of participants who can reach 6 months without the need for any intervention. The second sub-group analysis supports excluding participants prior to randomization in the Phase 3 trial who demonstrated significant non-disease related changes in visual acuity. This sub-group analysis removed visit data from participants who had a greater than 10 letter change in BCVA without a corresponding 50 micron change in CST from the previous visit. The analysis demonstrated compelling BCVA results and provided evidence that excluding this group of potential participants may reduce BCVA variability unrelated to wet AMD activity and therefore, may better ensure the CLS-AX Phase 3 data reflect real-world treatment practices. The presentation can be accessed here. Upcoming Sessions on CLS-AX Wet AMD Program The Macula Society 48th Annual Meeting (February 12-15, 2025) Presentation: Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration Presenter: Thomas A. Ciulla, MD, MBA, Chief Medical Advisor-Retina and Chair, Scientific Advisory Board, Clearside Biomedical 5th Annual Wet AMD & Diabetic Eye Disease Drug Summit (March 18-20, 2025) Presentation: Transforming wAMD Treatment: Long-Lasting, Flexible Dosing with Suprachoroidal TKI Delivery Presenter: Victor Chong, MD, MBA, Chief Medical Officer, Clearside Biomedical About ODYSSEY Phase 2b Clinical Trial ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week, Phase 2b clinical trial in participants with wet AMD previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. A total of 60 participants were treated for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX was administered via suprachoroidal injection using Clearside's SCS Microinjector, and aflibercept was administered via intravitreal injection. Participants in the trial were determined to have active disease with a median duration of wet AMD diagnosis of 9.9 months. The ODYSSEY trial achieved its objectives, including primary outcomes in mean change from baseline in best corrected visual acuity and safety and tolerability of CLS-AX, and secondary outcomes in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden as measured by total injections over the trial duration. CLS-AX demonstrated compelling intervention-free rates with 100% of CLS-AX participants not requiring any additional treatment up to 3 months, 90% up to 4 months, 81% up to 5 months, and 67% up to 6 months after the initial CLS-AX dose. In the CLS-AX group, the injection frequency was reduced by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening. About CLS-AX (axitinib injectable suspension) Clearside is developing CLS-AX as a longer-acting therapy for the treatment of retinal diseases. CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials in which CLS-AX was well tolerated and demonstrated a positive safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers by compartmentalizing axitinib behind the retina, thereby limiting drug exposure to the front of the eye. About Clearside's Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector® Clearside's patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The Company's unique platform is inherently flexible and intended to work with established and new formulations of medications. Clearside's patented SCS Microinjector® can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is comprised of a syringe with a custom-designed hub and two 30-gauge hollow microneedles of varying lengths, each approximately one millimeter, optimizing insertion and suprachoroidal administration of drugs. About Clearside Biomedical, Inc. Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside's SCS injection platform, utilizing the Company's patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company's lead program, CLS-AX (axitinib injectable suspension), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). Clearside developed and gained approval for its first product, XIPERE ® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit or follow us on LinkedIn and X. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'believe', 'expect', 'may', 'plan', 'potential', 'will', and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, including the planned Phase 3 trial design, as well as the potential benefits of CLS-AX, Clearside's suprachoroidal delivery technology and Clearside's SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, and Clearside's other periodic reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contacts: Jenny Kobin
Associated Press
28-01-2025
- Business
- Associated Press
Clearside Biomedical Announces Multiple Medical Meeting Presentations Focused on the Advantages of Suprachoroidal Delivery and Key Differentiators in its CLS-AX Clinical Program
- Upcoming Presentations at Angiogenesis and Macula Society Conferences to Feature CLS-AX Sub-Group Analyses from ODYSSEY Wet AMD Trial - - CLS-AX Targets Flexible Dosing of Biologics with Duration of Tyrosine Kinase Inhibitors - ALPHARETTA, Ga., Jan. 28, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today recent and upcoming presentations at ophthalmic medical meetings highlighting Clearside's suprachoroidal delivery technology and promising pipeline, including its Phase 3 ready CLS-AX program for the treatment of neovascular age-related macular degeneration (wet AMD). 'Our medical meetings this quarter continue to demonstrate the commercial, clinical and regulatory expertise that establishes Clearside as the leader in suprachoroidal delivery,' said Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development. 'We are excited about the potential of our CLS-AX program and look forward to presenting additional data from our Phase 2b ODYSSEY trial at upcoming meetings. We believe suprachoroidal CLS-AX has the potential to deliver comparable 6-month therapeutic effect in most wet AMD patients, similar to other intravitreal TKIs in development, while allowing physicians to have more individualized and flexible dosing options, instead of rescue, for patients who need more frequent therapy. We also believe suprachoroidal delivery enables the precise application of therapy to the retina, which may result in improved safety over other intravitreal treatment options.' Recent Sessions on Suprachoroidal Drug Delivery Utilizing Clearside's SCS Microinjector®: Hawaiian Eye & Retina 2025 (January 18-24, 2025) Presentation: Where Are We with Suprachoroidal Delivery Presenter: Judy E. Kim, MD, University of Texas Southwestern Medical Center Presentation: Suprachoroidal Delivery of Investigational ABBV-RGX-314 for Diabetic Retinopathy: The Phase II ALTITUDE ® Study Presenter: Margaret Chang, MD, MS, Retinal Consultants Medical Group Presentation: Tyrosine Kinases Inhibitors Presenter: Rishi P. Singh, MD, Cleveland Clinic Presentation: Suprachoroidal Delivery of Triamcinolone Injectable Suspension for Post-Operative Cystoid Macular Edema Presenter: Irena Tsui, MD, Doheny Eye Center UCLA 3rd Annual Ophthalmic Drug Delivery Summit (January 28-30, 2025) Presentation: Advancing Targeted, Compartmentalized, & Long-Acting Depot Delivery Suprachoroidal Delivery of Particulate Formulations Presenter: Viral Kansara, PhD, Vice President, Preclinical Development, Clearside Biomedical Upcoming Sessions on CLS-AX Wet AMD Program Angiogenesis, Exudation, and Degeneration 2025 (Virtual; February 8, 2025) Presentation: Phase 2b CLS-AX ODYSSEY Trial Results Presenter: Roger Goldberg, MD, MBA, Bay Area Retinal Associates Medical Group The Macula Society 48th Annual Meeting (February 12-15, 2025) Presentation: Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration Presenter: Thomas A. Ciulla, MD, MBA, Chief Medical Advisor-Retina and Chair, Scientific Advisory Board, Clearside Biomedical 5th Annual Wet AMD & Diabetic Eye Disease Drug Summit (March 18-20, 2025) Presentation: Transforming wAMD Treatment: Long-Lasting, Flexible Dosing with Suprachoroidal TKI Delivery Presenter: Victor Chong, MD, MBA, Chief Medical Officer, Clearside Biomedical About Clearside's Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector® Clearside's patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The Company's unique platform is inherently flexible and intended to work with established and new formulations of medications. Clearside's patented SCS Microinjector® can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is comprised of a syringe with a custom-designed hub and two 30-gauge hollow microneedles of varying lengths, each approximately one millimeter, optimizing insertion and suprachoroidal administration of drugs. About ODYSSEY Phase 2b Clinical Trial ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week, Phase 2b clinical trial in participants with wet AMD previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. A total of 60 participants were treated for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX was administered via suprachoroidal injection using Clearside's SCS Microinjector, and aflibercept was administered via intravitreal injection. Participants in the trial were determined to have active disease with a median duration of wet AMD diagnosis of 9.9 months. The ODYSSEY trial achieved its objectives, including primary outcomes in mean change from baseline in best corrected visual acuity and safety and tolerability of CLS-AX, and secondary outcomes in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden as measured by total injections over the trial duration. CLS-AX demonstrated compelling intervention-free rates with 100% of CLS-AX participants not requiring any additional treatment up to 3 months, 90% up to 4 months, 81% up to 5 months, and 67% up to 6 months after the initial CLS-AX dose. In the CLS-AX group, the injection frequency was reduced by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening. About CLS-AX (axitinib injectable suspension) Clearside is developing CLS-AX as a longer-acting therapy for the treatment of retinal diseases. CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials in which CLS-AX was well tolerated and demonstrated a positive safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers by compartmentalizing axitinib behind the retina, thereby limiting drug exposure to the front of the eye. About Clearside Biomedical, Inc. Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside's SCS injection platform, utilizing the Company's patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company's lead program, CLS-AX (axitinib injectable suspension), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). Clearside developed and gained approval for its first product, XIPERE ® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit or follow us on LinkedIn and X. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'believe', 'expect', 'may', 'plan', 'potential', 'will', and similar expressions, and are based on Clearside's current beliefs and expectations. These forward-looking statements include statements regarding the potential benefits of CLS-AX, Clearside's suprachoroidal delivery technology and Clearside's SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside's reliance on third parties over which it may not always have full control and other risks and uncertainties that are described in Clearside's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, and Clearside's other periodic reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Source: Clearside Biomedical, Inc.
