"Macular edema is the leading cause of vision loss in patients with uveitis," said
The data demonstrated that patients with noninfectious uveitis in the XIPERE study arm experienced clinically significant improvement in vision relative to the control arm, demonstrating the potential efficacy of suprachoroidal injection of XIPERE for the treatment of macular edema associated with uveitis. No serious adverse events (AEs) considered by the investigators related to treatment were reported.
"The publication of our positive Phase 3 XIPERE clinical trial results is an important milestone for Clearside as it expands the understanding of our suprachoroidal treatment approach," said
"We are encouraged by the results of these data as they demonstrated clinically meaningful improvement in vision for nearly half of the patients treated, further supporting the efficacy profile of XIPERE," said
About the Phase 3 PEACHTREE Study
The PEACHTREE study was a randomized, controlled, masked, Phase 3 clinical trial that evaluated the safety and efficacy of XIPERE in 160 patients with macular edema associated with noninfectious uveitis. Patients were randomized to receive XIPERE at baseline and at 12 weeks versus control. The PEACHTREE study met its primary endpoint, with 47 percent of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16 percent of patients in the control arm (p<0.001), using the standardized Early Treatment of Diabetic Retinopathy Study scale (visual acuity testing). All key secondary and additional endpoints of the PEACHTREE study were also achieved. No serious AEs considered by the investigators to be related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the XIPERE and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively).
XIPERE™ (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 that is being investigated 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. An affiliate of
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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 potential approval of XIPERE for the treatment of macular edema associated with uveitis, opportunities for expanding Clearside's internal pipeline, and the potential benefits of XIPERE and the SCS injection platform. 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
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1. Steven Y, et al. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3, Randomized Trial. Ophthalmology. 2020: doi:10.1016/j.ophtha.2020.01.006.
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