Clearside Biomed Stock Price, News & Analysis

Clearside Biomedical (NASDAQ: CLSD) announced the FDA approval of XIPERE™, the first product for injection into the suprachoroidal space, providing a new treatment for macular edema associated with uveitis. The approval will yield $19 million in non-dilutive funding from commercialization partners. Meanwhile, Clearside continues its Phase 1/2a trial of CLS-AX for wet AMD, with safety results expected by the year's end. The company reported a net loss of $4.9 million for Q3 2021, up from $2.4 million in the same period last year, attributed to increased R&D expenses.

Clearside Biomedical (NASDAQ:CLSD) announced the date for its third quarter 2021 financial results, set for November 10, 2021, post-market close. A webcast and conference call will follow at 4:30 p.m. ET, allowing investors and stakeholders to discuss the results and receive corporate updates. The company focuses on innovative treatment delivery to the back of the eye through its proprietary suprachoroidal space (SCS) Microinjector platform. Clearside’s first product, XIPERE™, gained FDA approval in October 2021.

XIPERE™, approved by the FDA, is the first medication for suprachoroidal injection in the U.S., targeting macular edema associated with uveitis. Developed by Bausch Health (BHC) and Clearside Biomedical (CLSD), it facilitates targeted delivery to the retina, potentially mitigating vision loss. Clinical trials indicate that 47% of patients showed significant visual acuity improvement compared to 16% in the control group. The product will be available in Q1 2022, offering a new therapeutic option in the eye health market.

Clearside Biomedical presented significant data at the American Society of Retina Specialists Annual Meeting, highlighting the promise of its suprachoroidal injection platform for treating various chorioretinal diseases. Notable presentations included positive outcomes from clinical trials of RGX-314 for diabetic retinopathy and AU-011 for choroidal melanoma, showcasing safety and efficacy. The company is progressing with its CLS-AX injectable suspension in a Phase 1/2a trial for wet AMD, aiming to improve treatment compliance and reduce vision loss risk. These advancements underline Clearside's commitment to vision restoration.

Clearside Biomedical (NASDAQ:CLSD) presented multiple findings at the Retina Society's 54th Annual Scientific Meeting held from September 29 to October 2, 2021, in Chicago. The presentations highlighted the efficacy and safety of their suprachoroidal injection method using the SCS Microinjector. Results from their partner REGENXBIO showed positive initial data from a Phase II trial for wet age-related macular degeneration (AMD) involving RGX-314, emphasizing the feasibility and safety of this innovative delivery approach. The company continues to develop XIPERE and CLS-AX for various retinal diseases.

Clearside Biomedical (NASDAQ: CLSD) has announced the completion of dosing in Cohort 2 of its Phase 1/2a OASIS clinical trial for CLS-AX, targeting neovascular age-related macular degeneration (wet AMD). This trial evaluates the safety and tolerability of CLS-AX via suprachoroidal injection. Following promising results from Cohort 1, Cohort 2 participants received doses of aflibercept and CLS-AX. Initial safety data from this cohort is expected by year-end. Wet AMD affects about 11 million individuals in the U.S., highlighting the critical need for effective treatments.

Clearside Biomedical (NASDAQ:CLSD) announced an expansion of its exclusive license with Arctic Vision for the drug XIPERE to include territories like Australia, New Zealand, India, and ASEAN countries, in addition to Greater China and South Korea. This move enables Clearside to enhance global access to its innovative suprachoroidal injection technology for treating macular edema associated with uveitis. The agreement includes a $3 million upfront payment and potential milestone payments, alongside tiered royalties of 10% to 12% on net sales.

Clearside Biomedical, Inc. (NASDAQ:CLSD) announced that Dr. Thomas A. Ciulla will present a company overview at the Ophthalmology Futures European 2021 Virtual Retina Forum on September 8, 2021. The event focuses on advancements in treating back of the eye diseases. The company specializes in biopharmaceuticals aimed at restoring vision, utilizing its proprietary SCS Microinjector^® for targeted medication delivery. Archived webcasts will be available for three months on the Clearside website.

Arctic Vision, a China-based biotech, has amended its exclusive license agreement with Clearside Biomedical (CLSD) to expand the territory for ARVN001 (XIPERE™) to include ASEAN countries and India. This proprietary corticosteroid suspension targets macular edema associated with uveitis. The U.S. FDA accepted Clearside's NDA filing for XIPERE in May 2021, while Arctic Vision plans to start a Phase III clinical trial in China in late 2021. The expansion aligns with Arctic Vision's strategic goals to enhance its commercial reach in Asia.