Clearside Biomedical Provides New Drug Application Update for XIPEREᵀᴹ (triamcinolone acetonide suprachoroidal injectable suspension)
In a meeting this week, the FDA’s
As a result of this request, Clearside expects to receive a Complete Response Letter from the
“After a productive meeting with the
Dr. Lasezkay continued, “This request does not impact in any way the SCS Microinjector platform targeting the delivery of therapeutic agents to the suprachoroidal space. We continue to focus on building our internal R&D initiatives and advancing discussions with potential partners interested in accessing the suprachoroidal space.”
Clearside believes the
XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye, thus potentially providing advantageous and sustained efficacy with a favorable safety profile.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the timing for resubmitting the XIPERE NDA, the receipt of a Complete Response Letter from the
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Source: Clearside Biomedical, Inc.