GenEditBio Limited announced in a press release that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application to initiate phase 1/2 CLARITY trial activities for its in vivo genome-editing program GEB-101 for TGFBI corneal dystrophy.

According to the company, the phase 1/2 CLARITY trial will collect initial data on the safety, tolerability, and efficacy of GEB-101 in corneal dystrophy patients with TGFBI mutation. The study has an adaptive, multicenter, sequential design, and trial participants will receive a single intrastromal injection of GEB-101. Patient enrollment is expected to commence in the second quarter of this year after site activation in the United States, the company reported.

TGFBI corneal dystrophy is a group of genetic eye disorders caused by mutations in the TGFBI gene, resulting in progressive abnormal protein buildup and deposits in the cornea. Symptoms include photophobia, gradual vision loss, and recurrent corneal erosions with debilitating pain, impacting patients' long-term quality of life. Current treatment options include phototherapeutic keratectomy (PTK) and corneal transplantation.