Clearside Biomed Stock Price, News & Analysis

Clearside Biomedical has reported positive safety results from its ongoing Phase 1/2a clinical trial of CLS-AX for treating wet age-related macular degeneration (AMD). The 0.1 mg dose in Cohort 2 (n=5) was well tolerated with no serious adverse events. The Safety Monitoring Committee approved advancing to Cohort 3, which will use a 0.5 mg dose. Patients in Cohorts 1 and 2 showed stable visual acuity and minimal retreatment visits, indicating potential efficacy. The company anticipates further data gathering, with patient screening for the next cohort already underway.

Clearside Biomedical (Nasdaq: CLSD) has been added to the Nasdaq Biotechnology Index, effective December 20, 2021. This index tracks biotechnology and pharmaceutical securities on Nasdaq, requiring companies to meet specific eligibility criteria, including market capitalization and trading volume. Clearside is known for its innovative delivery of therapies to the back of the eye via the suprachoroidal space (SCS), with its first product, XIPERE, recently approved by the FDA. The addition to the index underscores Clearside's standing in the biopharmaceutical sector.

Clearside Biomedical (NASDAQ:CLSD) has reported on promising clinical data at the American Academy of Ophthalmology (AAO) 2021. Their SCS Microinjector® technology for delivering therapeutics directly to the suprachoroidal space shows potential for treating conditions like wet AMD and diabetic retinopathy. The FDA-approved XIPERE™, a treatment for macular edema associated with uveitis, was highlighted with positive patient outcomes, including a 47% improvement in visual acuity.

Collaboration with partners like REGENXBIO and Aura Biosciences yielded encouraging data on gene therapies and cancer treatments.

Clearside Biomedical, a biopharmaceutical firm focused on ocular therapies, announced its participation in four upcoming virtual investor events, showcasing its innovative suprachoroidal space (SCS) delivery system. Key events include the Stifel 2021 Virtual Healthcare Conference on November 17, Piper Sandler Annual Conference from November 29 to December 2, BTIG Ophthalmology Day on November 30, and UBS Ophthalmology Day on December 6. The first product, XIPERE, received FDA approval in October 2021, enhancing treatment options for eye diseases.

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.