08:56 AM EDT, 06/24/2024 (MT Newswires) -- 4D Molecular Therapeutics ( FDMT ) said Monday the US Food and Drug Administration has cleared its Investigational New Drug Application for 4D-175, a genetic medicine to potentially treat geographic atrophy or GA.

The clinical-stage genetic medicines company said the therapy uses the R100 vector and a shortened form of human complement factor H to target GA, a severe form of age-related macular degeneration.

The approval allows 4D Molecular to start setting up clinical study sites for the GAZE trial, with enrolment expected to begin in H2, the company said.

4D Molecular said the phase 1 GAZE clinical trial will evaluate 4D-175 in patients with GA caused by age-related macular degeneration.

The trial will involve a sequential group dose exploration phase, where participants will receive a single intravitreal injection of 4D-175 at one of three dose levels. The main goals of the trial include assessing safety and tolerability, determining appropriate dose levels for phase 2 trials, and evaluating the expression and biological effects of the transgene, the company said.