Clearside Biomedical Announces SAPPHIRE Phase 3 Study of Combination Therapy in Retinal Vein Occlusion Did Not Meet Its Primary Endpoint
- Focusing Resources on Uveitis Program; NDA Filing Expected Fourth Quarter 2018 -
- Company to Host Conference Call at
“In the SAPPHIRE trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision; unfortunately, there was no additional benefit for patients receiving XIPERE together with intravitreal Eylea,” said
“We believe the opportunity in our primary indication, uveitis, remains very attractive. Awareness and acceptance of the strong clinical profile of XIPERE as a potential monotherapy in treating uveitic macular edema is growing, and we remain on track to submit our NDA for this indication before the end of this year,” added Mr. White.
Topline SAPPHIRE Trial Results
SAPPHIRE, a multicenter, multi-country, randomized, masked, controlled Phase 3 clinical trial, enrolled 460 patients with treatment naïve RVO. A similar proportion of patients in both arms of the SAPPHIRE trial gained at least 15 ETDRS letters in BCVA at eight weeks, showing no additional visual outcome benefit for patients in the XIPERE-plus- intravitreal Eylea combination arm compared to patients in the intravitreal Eylea-alone control arm. The safety profile appeared consistent with previous studies of XIPERE through 8 weeks.
Conference Call & Webcast Details
Clearside invites all interested parties to participate in a conference call today at
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 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.
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, the potential attributes and benefits of Clearside’s product candidates, and the timing of a potential submission of an NDA with the
Chief Financial Officer
Source: Clearside Biomedical, Inc.