Clearside Biomedical (NASDAQ:CLSD) has enrolled the first patient in a Phase 1/2 study, known as the HULK trial, of Zuprata, its proprietary suspension formulation of the corticosteroid triamcinolone, acetonide, for the treatment of diabetic macular edema (DME).
The HULK trial is an open-label, multi-center study designed to assess the safety and efficacy of the administration of Zuprata to the suprachoroidal space concomitant with intravitreal aflibercept, as well as suprachoroidal Zuprata monotherapy, in patients with DME.
The trial expects to enroll about 20 patients, with approximately equal numbers in each of the two arms. Anatomical and functional data and safety information will be collected at each monthly visit during the six-month evaluation period.
“In the Phase 2 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 and CEO, Daniel White, said in a statement.
Data from the TANZANITE trial laid the groundwork for expansion of the development programs for suprachoroidal Zuprata to include the potential treatment of DME, he added.
“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,” Mr. White said.