Clearside Biomedical, Inc. (NASDAQ:CLSD) Files An 8-K Other Events
Item 8.01 Other Events.
Clearside Biomedical, Inc. (the “Company”) provided an update regarding the Company’s New Drug Application (“NDA”) for XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of macular edema associated with uveitis.
As previously disclosed, the U.S. Food and Drug Administration (“FDA”) requested additional data on clinical use of the final to-be-marketed SCS Microinjector™ delivery system in at least 30 patients. In response to that request, the Company proposed the submission of clinical use information in 160 subjects from its TOPAZ study for the treatment of macular edema associated with retinal vein occlusion. In recent meeting correspondence, the FDA agreed that it would be acceptable for the Company to submit such data in lieu of the requested clinical use assessment. As a result, the Company no longer plans to conduct an additional clinical use assessment with the SCS Microinjector. As previously disclosed, the Company plans to re-submit the XIPERE NDA in the second quarter of 2020.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this Current Report on Form 8-K 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 the Company’s current beliefs and expectations. These forward-looking statements include statements regarding the timing for resubmitting the XIPERE NDA and the anticipated outcome of interactions with the FDA. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, the Company’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2019, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 8, 2019, and the Company’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this Current Report on Form 8-K and are based on information available to the Company as of the date of this Current Report on Form 8-K, and the Company assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
About Clearside Biomedical, Inc. (NASDAQ:CLSD)
Clearside Biomedical, Inc. is a clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye. The Company’s product candidates focus on diseases affecting the retina, which is the tissue that lines the inside of the eye and is primarily responsible for vision, and the choroid, which is the layer adjacent to the retina that supplies the retina with blood, oxygen and nourishment. With its microinjector, drugs are injected into and spread within and through the suprachoroidal space, (SCS), which is the space located between the choroid and the outer protective layer of the eye known as the sclera. With the suprachoroidal injection, its product candidates are more directly administered to the retina and choroid as compared to other ocular drug administration techniques, such as injections of drug into the vitreous, a jelly-like substance that occupies the central portion of the eye.
