Clearside Biomedical Submits New Drug Application for XIPERE™ for the Treatment of Macular Edema Associated with Uveitis
The uveitis market is expected to grow by 2024 to nearly
If approved by the
“Based on the data from PEACHTREE, our pivotal Phase 3 clinical trial, we believe that XIPERE has the potential to become a new paradigm in the treatment of uveitic macular edema,” said
XIPERE, Clearside’s first investigational treatment to reach NDA submission, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via suprachoroidal injection into the space located between the choroid and the outer protective layer of the eye known as the sclera. Clearside’s proprietary suprachoroidal treatment approach is designed to enable rapid dispersion of medicine to the back of the eye, so that adequate medicine reaches and stays at the site of disease and has the potential to act longer, while minimizing harm to the surrounding healthy parts of the eye. This approach has potential to provide efficacy advantages and require fewer treatments.
PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, and compared XIPERE dosed every 12 weeks to sham control.
The PEACHTREE trial met its primary endpoint, with 47% of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity, as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, compared to 16% of patients in the sham control arm (p<.001). All key secondary and additional endpoints of the PEACHTREE trial were also achieved.
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 expectations regarding the potential clinical development of Clearside’s product candidates, the availability of data from Clearside’s clinical trials, the timing of marketing authorization applications with regulatory agencies in Europe and other jurisdictions, and the potential commercialization of XIPERE, both in the United States and internationally. 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, Clearside’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 16, 2018, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, and Clearside’s other Periodic Reports filed with the
Chief Financial Officer
Source: Clearside Biomedical, Inc.