Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in clinical trial of its suspension formulation of corticosteroid triamcinolone acetonide, Zuprata, for the treatment of diabetic macular edema.
The Alpharetta, Ga.-based company’s Hulk Phase I/II trial is an open-label, multi-center study designed to evaluate the safety and efficacy Zuprata administered in the suprachoroidal space along with intravitreal aflibercept and as an independent therapy in patients with diabetic macular edema. The trial is slated to enroll 20 patients with equal participation in both arms. Anatomical and functional data as well as safety information will be collected at monthly visits over a 6-month period, according to Clearside.
“In the Phase II Tanzanite trial of suprachoroidal Zuprata concomitant with intravitreal aflibercept in patients with macular edema due to retinal vein occlusion, or RVO, we observed encouraging visual acuity and macular edema improvements,” president & CEO Daniel White said in prepared remarks. “Those data have laid the groundwork for this expansion of the development programs for suprachoroidal Zuprata to include the potential treatment of DME. Importantly, the initiation of the Hulk trial marks the fourth indication for Zuprata we have announced to date, and, if successful, could significantly expand the potential patient population for Clearside’s suprachoroidal treatments.”