Tarsier Pharma has received agreement for a Special Protocol Assessment (SPA) for the clinical trial protocol and planned statistical analysis of the Tarsier-04 phase 3 trial to evaluate topical dazdotuftide (formerly TRS01) for the treatment of noninfectious uveitis, including uveitic glaucoma.

“The SPA agreement with the FDA provides a clear regulatory path for TRS01,” said Daphne Haim-Langford, PhD, the founder and chief executive officer of Tarsier. “The primary endpoint in this FDA-approved protocol is one that achieved an alpha <.01 in the TRS4Vision trial, thus we have strong reasons to believe that the endpoints of Tarsier-04 will be met, and this SPA agreement with the FDA is bringing TRS01 much closer to patients in need.”

Dazdotuftide is a bioinspired technology platform found to modulate inflammatory macrophages and IL-10 secreting anti-inflammatory macrophages, according to the company.