Clearside Biomedical, Inc. - CLSD STOCK NEWS

Clearside Biomedical, Inc. (Nasdaq: CLSD) has resubmitted its New Drug Application (NDA) for XIPERE^TM (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.

Clearside Biomedical (NASDAQ:CLSD) announced it will report its fourth quarter and full year 2020 financial results on March 10, 2021, after market close. A conference call will follow at 4:30 p.m. ET for a discussion of the results and corporate updates. The event will be accessible via the company's Investors section on their website. Clearside specializes in treatments for severe back-of-the-eye diseases, utilizing its SCS Microinjector technology for targeted delivery of medications.

Clearside Biomedical, a biopharmaceutical company focused on vision restoration, will participate in two investor conferences in March 2021. The first is the Cowen 41st Annual Health Care Conference on March 2, at 2:10 pm ET, focusing on clinical development. The second event is the 33rd Annual ROTH Conference on March 16, at 9:00 am ET, featuring an ophthalmology panel. Both panels will be accessible online, and management will engage in live, virtual one-on-one meetings with registered investors.

Clearside Biomedical (NASDAQ:CLSD) presented the delivery method of axitinib for wet AMD at a recent conference. Dr. David M. Brown highlighted its advantages, including ease of administration and superior potency compared to existing treatments. Preclinical studies showed that Clearside's suprachoroidal delivery of axitinib (CLS-AX) resulted in significantly higher drug levels in tissues, potentially reducing side effects and treatment burden. The ongoing Phase 1/2a OASIS trial aims to assess the safety and tolerability of CLS-AX, with initial results expected mid-2021.

Clearside Biomedical (NASDAQ:CLSD) announced significant clinical findings at the 44th Virtual Annual Macula Society Meeting, showcasing their suprachoroidal injection platform's potential for treating various retinal disorders. Notably, CLS-AX, an injectable suspension of axitinib, is currently in a Phase 1/2a trial for wet age-related macular degeneration. The SCS Microinjector has facilitated over 1,000 injections, demonstrating broad applicability, safety, and efficacy in conditions like macular edema and diabetic retinopathy. Upcoming presentations at conferences further highlight their innovative treatment strategies.

Clearside Biomedical, Inc. (NASDAQ:CLSD) has announced the enrollment of the first patients in its Phase 1/2a clinical trial for CLS-AX, a novel axitinib injectable suspension for treating wet age-related macular degeneration (AMD). The trial, named OASIS, aims to assess the safety and tolerability of CLS-AX via suprachoroidal injection. The study will include 15 patients across 3 cohorts with varying dosage levels. Positive preclinical results indicate that CLS-AX could alleviate treatment burdens compared to existing therapies. Initial data is expected in mid-2021.