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|Clearside Biomedical, Inc. Announces First Patient Randomized in Phase 3 Clinical Trial of Zuprata™ Used Together With Eylea in Subjects With Retinal Vein Occlusion|
SAPPHIRE is a multicenter, randomized, masked, controlled trial to assess the efficacy and safety of suprachoroidally administered Zuprata (“suprachoroidal Zuprata”) used together with intravitreally administered Eylea (“intravitreal Eylea”) in subjects with RVO. Patients in the combination treatment arm will receive suprachoroidal Zuprata together with intravitreal Eylea at the beginning of the trial, intravitreal Eylea alone at week 4, and suprachoroidal Zuprata together with intravitreal Eylea at weeks 12 and 24. Patients in the control arm will receive intravitreal Eylea alone at the beginning of the trial and follow-up treatments of intravitreal Eylea alone every four weeks through week 24. After 24 weeks, patients will be followed for approximately an additional six months. The primary objective of this trial will be to determine the proportion of patients in each arm with a best corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment. There will be several secondary efficacy and safety endpoints that will also be evaluated. Clearside anticipates total enrollment of approximately 460 patients in the trial.
“This patient’s enrollment represents another significant milestone in our Zuprata development program,” said
Suprachoroidal Zuprata used together with intravitreal Eylea for RVO is part of Clearside’s pipeline of drug treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the choroid or retina.
About Retinal Vein Occlusion
RVO is a sight-threatening disorder resulting from a blockage of one or more of the veins carrying blood out of the retina. This blockage can lead to bleeding within the retina and the additional fluid can cause swelling resulting in macular edema. This bleeding and macular edema can affect central vision. According to a 2010 study published in the journal Ophthalmology, RVO is estimated to affect more than 16 million adults worldwide. Of those, Clearside estimates approximately 2.2 million reside in the United States.
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, and the potential market for, Clearside’s product candidates. 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 Quarterly Report on Form 10-Q for the quarter ended