The FDA has cleared a phase 1/2 clinical trial of NouvSight001, an investigational allogeneic photoreceptor cell therapy for retinitis pigmentosa (RP), according to iRegene Therapeutics.

NouvSight001 is an off-the-shelf cell replacement therapy intended to replace photoreceptors lost to retinal degeneration. Because the approach is not directed at a specific disease-causing mutation, it is designed for potential use across genetically diverse forms of RP.

The therapy is produced using iRegene’s “AI + Chem” platform, which combines artificial intelligence, systems biology, and chemical induction to control cell differentiation. The company said the platform is intended to support standardized and scalable manufacturing of allogeneic cell therapies.

NouvSight001 previously received FDA orphan drug designation in 2024. iRegene also said China’s National Medical Products Administration has cleared a phase 1/3 trial of the therapy in patients with RP to evaluate safety, tolerability, and preliminary efficacy.

The company did not provide enrollment targets or timelines for the US or Chinese studies in its announcement. RP