Clearside Biomedical
Clearside Biomedical developed the first FDA-approved product for suprachoroidal administration and offers XIPERE®, the first therapy for macular edema associated with uveitis. Their SCS Microinjector® enables targeted, non-surgical delivery of therapies to the back of the eye.
FDA-Approved Products
Clearside Biomedical made a significant advancement in ophthalmology by developing XIPERE®, the first and only FDA-approved product for suprachoroidal administration. XIPERE® is specifically approved as a therapy for macular edema associated with uveitis, making it a groundbreaking therapeutic delivered into the suprachoroidal space.
SCS Microinjector® Technology
The SCS Microinjector® is a key innovation from Clearside Biomedical, providing an in-office, repeatable, non-surgical procedure for targeted delivery of therapies to the macula, retina, or choroid. This technology has a safety profile comparable to intravitreal injections and enables rapid dispersion of medicine to the back of the eye. It is used in thousands of suprachoroidal injections for multiple retinal disorders, offering potentially improved efficacy and compartmentalization of medication.
Pipeline and Clinical Trials
Clearside Biomedical's lead program, CLS-AX (axitinib injectable suspension), is currently in Phase 2b clinical testing for the treatment of neovascular age-related macular degeneration (wet AMD). In addition to CLS-AX, Clearside has a pipeline of small molecule product candidates designed for administration via its SCS Microinjector®, aimed at treating various ocular diseases.
Partnerships and Collaborations
Clearside Biomedical collaborates with several companies, leveraging its SCS injection platform to enhance other ophthalmic therapeutic innovations. These partnerships enable the use of the SCS Microinjector® with both established medications and new formulations, promoting future innovations in ocular therapy.
Certifications and Standards
Clearside Biomedical adheres to high standards of quality and safety, as evidenced by its International Organization for Standardization (ISO) Certification EN ISO 13485:2016. This certification underscores the company's commitment to maintaining stringent regulatory compliance and quality assurance in its medical device development and production processes.