At the meeting, Dr. Khurana shared XIPERE’s efficacy data in resolving uveitic inflammation for the first time at a scientific congress. Dr. Khurana also presented new analyses of resolution of clinically significant vitreous haze, as well as the mean change from baseline in best corrected visual acuity (“BCVA”) in patients with uveitis in each anatomical location, providing further support for the clinical profile of XIPERE in the potential treatment of uveitic macular edema.
Resolution of Signs of Uveitis
In the PEACHTREE trial, at week 24, 40.9% of patients with baseline scores of 2+ vitreous haze, based on the Standardization of Uveitis Nomenclature (“SUN”) scale, experienced resolution in the XIPERE arm, compared to 0% of patients in the control arm who underwent a sham procedure. Additionally, in the XIPERE arm, 68% of patients with any baseline level of vitreous haze, 72% of patients with anterior chamber cell inflammation and 74% of patients with anterior chamber flare had their inflammation resolve, compared to 23%, 17% and 20%, respectively, of patients in the control arm. Resolution was defined as achieving a score of zero on the applicable SUN scale, implying no measureable inflammation was present.
“The PEACHTREE trial was the first pivotal Phase 3 clinical trial to demonstrate improvement in vision for patients with uveitic macular edema, and patients experiencing resolution of uveitis is an important outcome for uveitis specialists and for their patients,” commented Dr. Khurana. “These additional data add to my confidence that XIPERE holds promise for my patients with uveitic macular edema.”
Change in BCVA Across Anatomical Locations of Uveitis
Dr. Khurana also presented an analysis of the mean change in BCVA, from baseline at week 24 from each anatomical location of uveitis: Anterior, Intermediate, Posterior and Panuveitis.
|Mean Change From Baseline in BCVA at Week 24 by Anatomical Location|
“Unlike current therapies, which have shown efficacy in certain locations of uveitis, such as anterior or posterior segment uveitis, patients treated with XIPERE in the PEACHTREE trial achieved visual improvement across all anatomical locations of uveitis. This serves to further differentiate the impressive clinical profile of XIPERE,” said Dr. Khurana.
XIPERE, Clearside’s first investigational treatment, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via the suprachoroidal space, or SCS®, which is 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 potential to act longer. This approach has potential to provide efficacy advantages and require fewer treatments and office visits while minimizing harm to the surrounding healthy parts of the eye.
XIPERE, used either alone or together with an intravitreal anti-VEGF agent, is being studied as part of Clearside’s pipeline of treatments for unmet or underserved sight-threatening eye diseases that manifest in the retina and the choroid. Clearside expects to submit a New Drug Application (“NDA”) to the
PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, comparing XIPERE dosed every 12 weeks to sham control.
The PEACHTREE trial met its primary endpoint at 24 weeks, with 47% of patients in the XIPERE arm gaining at least 15 ETDRS letters in BCVA from baseline, compared to 16% of patients in the sham control arm (p<0.001). All key secondary and additional endpoints of the PEACHTREE trial were also achieved.
Uveitis, a set of inflammatory conditions affecting the eye, is one the world’s leading causes of blindness. Uveitis occurs in about 350,000 patients in
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 clinical development of Clearside’s product candidates, and the timing of a potential submission of an NDA with the