Clearside Biomedical Inc. recently released the reports from its Phase II TANZANITE clinical trial showing top-line data from the study.
Clearside is a late-stage clinical biopharmaceutical company that develops therapies for the treatment of blinding diseases in the eye.
The trial evaluated the treatment of macular edema associated with retinal vein occlusion (RVO) in patients that had not been treated previously. It included an “active” arm of concomitant suprachoroidally administered Zuprata, Clearside’s proprietary form of triamcinolone acetonide, and intravitreally administered aflibercept, Eylea, from Regeneron Pharmaceuticals, Inc.
“Two of the primary needs in treating retinal disease are achieving maximal visual improvements as quickly as possible and then maintaining those visual gains for longer periods of time to provide the potential to reduce the need for frequent treatments, especially in a difficult to treat retinal vascular disease like RVO,” CEO and President of Clearside Daniel H. White said. “The data from the TANZANITE trial supports the potential of suprachoroidal delivery to yield visual acuity gains more rapidly with fewer treatments using Zuprata concomitantly with VEGF inhibitors like Eylea in retinal vascular disease, and these clinical data provide support for pursuing further development of Zuprata for the treatment of retinal vascular diseases like RVO and diabetic macular edema (DME).”
The trial consisted of 46 patients who either received one intravitreal injection of Eylea along with Zuprata or just an injection of Eylea. The patients were then assessed once every three months, with 78 percent in the active arm of TANZANITE trial not needing additional treatment.
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