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Clearside Biomedical, Inc. (symbol: CLSD) is a prominent clinical biopharmaceutical company based in Alpharetta, Georgia. Specializing in the development of pharmacological therapies, the company's primary focus is on treating blinding diseases of the eye through their innovative suprachoroidal space (SCS) technology.
Clearside Biomedical's cornerstone is their SCS Microinjector®, a proprietary device that facilitates a non-surgical, office-based procedure. This technology allows for targeted delivery of therapies directly to the macula, retina, or choroid, which could potentially preserve and enhance vision for patients suffering from severe eye conditions.
One of the company's significant achievements is the robust safety profile and encouraging efficacy data from multiple studies using the SCS Microinjector®. These findings have been featured in numerous oral and poster presentations, highlighting the potential of Clearside’s technology in ophthalmic therapeutics.
Clearside Biomedical continues to advance its pipeline of ophthalmic therapies, collaborating with various partners to bring innovative treatments to market. The company remains committed to improving the quality of life for individuals with vision-threatening diseases through groundbreaking research and development.
Recent Achievements:
- Clinical data utilizing Clearside’s suprachoroidal delivery technology featured in multiple presentations.
- Enhanced safety and efficacy data presented, showcasing the utility of the SCS Microinjector®.
Investors and media can reach out to Jenny Kobin and Remy Bernarda for more information at ir@clearsidebio.com or by calling (678) 430-8206.
Clearside Biomedical (NASDAQ:CLSD) announced positive safety results from Cohort 1 of its OASIS Phase 1/2a clinical trial of CLS-AX for neovascular age-related macular degeneration (wet AMD). The 0.03 mg dose was well-tolerated, with no treatment-related adverse events. Cohort 2 patient screening for the 0.1 mg dose will begin in June 2021. The preliminary data showed that five out of six patients improved their best corrected visual acuity after receiving CLS-AX. The trial will advance to higher doses, with expected results from Cohorts 2 and 3 by year-end.
Clearside Biomedical (NASDAQ:CLSD) announced participation in two investor conferences in June 2021. George Lasezkay, CEO, and Thomas A. Ciulla, Chief Medical Officer, will host fireside chats at:
- JMP Securities Life Sciences Conference: June 16, 2021, at 1:00 pm ET
- Raymond James Human Health Innovations Conference: June 23, 2021, at 8:40 am ET
Live and archived webcasts can be found on the company's website. Clearside specializes in treatments for serious eye diseases using its proprietary SCS Microinjector technology.
Bausch Health and Clearside Biomedical announced that the FDA has accepted the resubmitted New Drug Application for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension). The PDUFA action date is set for October 30, 2021. XIPERE targets macular edema associated with uveitis, a leading cause of vision loss. If approved, it would be the first therapy utilizing the suprachoroidal space for treatment. Clearside's SCS Microinjector aims to improve drug delivery, potentially minimizing adverse effects compared to traditional methods.
Clearside Biomedical (NASDAQ:CLSD) announced its New Drug Application resubmission for XIPERE, intended for treating macular edema associated with uveitis. This would mark the company's first commercial product if approved. The company also reported a net loss of $7.4 million for Q1 2021, significantly higher than the $2.9 million loss in Q1 2020, largely due to increased R&D expenses of $5.5 million. However, cash reserves stand at $26.1 million, providing operational runway through Q1 2022. Cohort 1 data from the ongoing OASIS Phase 1/2a trial is expected in June 2021.
Clearside Biomedical (NASDAQ:CLSD) presented clinical data on its suprachoroidal injection platform at the ARVO 2021 Virtual Meeting (May 1-7). Key highlights include progress in the CLS-AX clinical program and an ongoing review of XIPERE by the FDA. Studies showed that suprachoroidal injections can enhance safety and efficacy for retinal disorders. The company emphasized the importance of their proprietary delivery systems and reported safety profiles comparable to traditional methods. The need for improved long-term therapies for retinal diseases remains a focus amid ongoing clinical trials.
Clearside Biomedical (NASDAQ:CLSD) will report its first quarter 2021 financial results on May 17, 2021, after market close. A conference call and webcast will follow at 4:30 p.m. ET, providing insights into financial performance and corporate updates. Clearside, dedicated to treatments for serious back of the eye diseases, utilizes its proprietary SCS Microinjector to deliver medications effectively. The live and archived webcasts will be accessible on the Clearside website, with contact information for investor inquiries provided.
Clearside Biomedical, Inc. (Nasdaq: CLSD) has resubmitted its New Drug Application (NDA) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) to the FDA for treating macular edema associated with uveitis. This resubmission addresses all items from the Complete Response Letter received on October 18, 2019, and is expected to be reviewed under a six-month timeline. The company emphasizes XIPERE's potential as a non-surgical treatment option, highlighting support from its partners, Bausch + Lomb and Arctic Vision.
Clearside Biomedical (NASDAQ:CLSD) announced that Thomas A. Ciulla, M.D., CMO, will present at two virtual conferences in April 2021. The first is the Needham Virtual Healthcare Conference on April 12 at 12:45 p.m. ET, with live access on their website. The second is the Wet AMD & DME Drug Development Summit on April 14, featuring discussions on treatment burdens and innovative drug delivery solutions for serious eye diseases. Clearside focuses on therapies to restore vision and utilizes its proprietary SCS Microinjector for targeted drug delivery.
Clearside Biomedical (NASDAQ:CLSD) has initiated the OASIS Phase 1/2a clinical trial for treating wet AMD, completing dosing for Cohort 1 with initial safety data expected mid-2021. The company reported Q4 2020 financial results, showing a net loss of $7.1 million, with a significant increase in R&D expenses attributed to the CLS-AX trial. Despite a decrease in licensing revenue to $11,000, Clearside's full-year revenue rose to $7.9 million. As of December 31, 2020, the company had $17.3 million in cash, bolstered by a $14.4 million direct offering in January 2021, which will support operations into Q1 2022.
Clearside Biomedical, Inc. (NASDAQ:CLSD) has completed dosing in the first cohort of its Phase 1/2a clinical trial, OASIS, for CLS-AX aimed at treating wet age-related macular degeneration (AMD). This multi-center, open-label trial assesses the safety of CLS-AX, administered via suprachoroidal injection. The primary endpoint is safety and tolerability over three months. Initial safety data is expected by mid-2021, with plans to escalate doses in future cohorts. CLS-AX leverages the SCS Microinjector technology to optimize drug delivery, potentially improving treatment outcomes for patients.
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