Ractigen Therapeutics said the FDA has cleared its investigational new drug application for RAG-1C, allowing the company to begin a phase 1 trial of the investigational small activating RNA therapy in patients at high risk of proliferative vitreoretinopathy (PVR). No pharmacologic therapy is currently FDA approved for the prevention or treatment of PVR.

The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of intravitreal RAG-1C in patients undergoing surgery for retinal detachment who are considered at increased risk for PVR. RAG-1C is designed to deliver a small activating RNA, or saRNA, that reactivates expression of the endogenous p21 (CDKN1A) gene. According to Ractigen, increasing p21 expression in target ocular cells is intended to induce cell-cycle arrest and inhibit cellular proliferation and myofibroblast transformation, processes involved in PVR development. RP