- Broad Use of Suprachoroidal Injection Platform Highlighted Across Retinal Indications - - CLS-AX Combines the Flexibility of Anti-VEGF Therapies with the Long-Lasting Benefits of a Tyrosine Kinase Inhibitor - ALPHARETTA, Ga., June 17, 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 the use of its SCS de ...

Summary of Clearside Biomedical Conference Call Company Overview - Clearside Biomedical focuses on delivering therapeutic agents to the suprachoroidal space, pioneering a proprietary injection procedure and device for this purpose [4][5] - Established partnerships with Oral Biosciences and REGENXBIO for developing treatments for choroidal melanoma and retinal diseases [5][6] - Commercialization partnerships with Bausch and Lomb and Arctic Vision for their FDA-approved product XIPERE, which delivers triamcinolone to the suprachoroidal space [6] Core Product and Development - XIPERE has shown better performance in terms of duration and effect than predicted by pharmacokinetic models, leading to increased acceptance among physicians [10][14] - Development of CLS AX (axitinib) for wet AMD, with successful completion of phase 2b ODICEY trial, positioning it as a phase 3 ready product [7][8] - The product aims for flexible dosing with a duration comparable to biologics, targeting a market need for variability in patient responses [16][26] Competitive Landscape - CLS AX is positioned against current TKI competitors that offer a six-month duration, with Clearside aiming for a three to six-month duration to accommodate patient variability [15][21] - The company believes its product has a better efficacy profile due to a lower IC50 and a more favorable redosing criteria compared to competitors [19][20] - Emphasis on the absence of ocular serious adverse events (SAEs) in their trials, which contrasts with some competitors [20] Regulatory Strategy - The phase 3 trial is designed to last two years, with a primary endpoint at 52 weeks, allowing for two cycles of treatment [31][32] - The trial design aims to minimize variability by excluding patients with high variability in results, which has been accepted by regulatory agencies [39][42] - The company is focused on a non-inferiority design with good masking to mitigate regulatory risks associated with treatment failures [48][49] Funding and Future Plans - Ongoing outreach to strategic partners and potential investors to fund the advancement of CLS AX into phase 3 trials [50] - The company is exploring various funding options, including combinations of investors and strategic partnerships [50] Additional Insights - The acceptance of suprachoroidal injections is increasing, with over 15,000 injections performed and more than 100 peer-reviewed publications supporting the procedure [14] - The company believes that the flexibility in dosing frequency will be appealing to physicians and align with real-world clinical practices [44][45]

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) to improve patient outcomes [3] - The company utilizes a patented SCS Microinjector for an in-office, repeatable, non-surgical procedure aimed at targeted delivery of therapies to the macula, retina, or choroid [3] - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, with its lead program, CLS-AX, in development for treating neovascular age-related macular degeneration (wet AMD) [3] Product Development - The company is planning a Phase 3 program for its lead product, CLS-AX (axitinib injectable suspension) [3] - Clearside is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - The first product developed by Clearside, XIPERE (triamcinolone acetonide injectable suspension), has been approved for suprachoroidal use and is available in the U.S. through a commercial partner [3] Upcoming Events - Management will participate in a fireside chat at the Stifel 2025 Virtual Ophthalmology Forum on May 27, 2025, at 9:00 a.m. ET [1] - A live and archived webcast of the event will be accessible on the Clearside website under the Investors section, with the archive available for three months [2]

Core Insights - Clearside Biomedical has successfully completed an End-of-Phase 2 meeting with the FDA, leading to alignment on the Phase 3 program design for CLS-AX in wet AMD [1][5] - The company aims for a flexible three-to-six-month dosing label for CLS-AX, which is expected to be commercially attractive if approved [2][5] - Significant progress has been made by Clearside's partners in advancing their programs, including approvals and ongoing clinical trials [2][5] Recent Highlights - BioCryst Pharmaceuticals has received authorization to initiate its first clinical trial in Australia for avoralstat, targeting diabetic macular edema [5] - Arctic Vision's NDA for ARCATUS has been accepted for review in China, with approvals already granted in Australia and Singapore [5] - Over 15 presentations on suprachoroidal drug delivery were made at major ophthalmic medical meetings this year, showcasing advancements in retinal disease treatments [1][5] Financial Results - License and other revenue for Q1 2025 was $2.3 million, a significant increase from $0.2 million in Q1 2024, primarily due to license fees from partners [8][11] - R&D expenses decreased to $4.5 million in Q1 2025 from $5.6 million in Q1 2024, attributed to lower clinical trial costs [8][11] - The net loss for Q1 2025 was $8.2 million, or $0.11 per share, compared to a net loss of $11.8 million, or $0.17 per share, in Q1 2024 [8][11] Company Overview - Clearside Biomedical focuses on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, aiming to improve patient outcomes [6] - The company's lead program, CLS-AX, is in development for the treatment of wet AMD, with plans for a Phase 3 program underway [6] - Clearside has developed its first product, XIPERE, which is commercially available in the U.S. through a partner [6][9]

Strong Clinical Evidence Supports Use of the Suprachoroidal Platform in Expanding the Standard of Care for the Treatment of Multiple Macular DiseasesALPHARETTA, Ga., May 09, 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 six presentations related to the Company’s lead program, CLS-AX (axitinib injectable ...

ALPHARETTA, Ga., May 08, 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 its first quarter 2025 financial results will be reported on Wednesday, May 14, 2025 after the close of the financial markets. The Company will not be hosting a conference call this quarter. Information about the Company’s quarterly ...

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) [3] - The company utilizes a patented SCS Microinjector for an in-office, repeatable, non-surgical procedure aimed at delivering therapies to the macula, retina, or choroid [3] - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, with its lead program, CLS-AX, targeting neovascular age-related macular degeneration (wet AMD) [3] Product Development - The company is planning a Phase 3 program for its lead product, CLS-AX (axitinib injectable suspension) [3] - Clearside is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - The first product developed by Clearside, XIPERE (triamcinolone acetonide injectable suspension), has been approved for suprachoroidal use and is available in the U.S. through a commercial partner [3] Upcoming Events - Management will participate in a fireside chat at the Citizens Life Sciences Conference on May 7, 2025, at 1:00 p.m. ET [1] - A live and archived webcast of the event will be accessible on the Clearside website under the Investors section, with the archive available for three months [2]