Ractigen Therapeutics, a clinical-stage biopharmaceutical company focused on small activating RNA (saRNA) therapeutics, announced on Friday that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for RAG-1C, a first-in-class saRNA drug candidate designed for the prevention and treatment of Proliferative Vitreoretinopathy (PVR).

PVR is a severe, sight-threatening complication that occurs following rhegmatogenous retinal detachment (RRD) or ocular trauma, driven by the abnormal proliferation and migration of retinal pigment epithelium (RPE) cells and fibroblasts. There are currently no FDA-approved pharmacological therapies for PVR, and surgical intervention often has high rates of failure and recurrent retinal detachment.

According to Ractigen, RAG-1C is the first saRNA therapy in ocular diseases to enter global clinical development in both the United States and China. IND approval was received from China's National Medical Products Administration (NMPA/CDE) in March 2025.

RAG-1C uses Ractigen's proprietary LiCO (Lipid-Conjugated Oligonucleotide) platform to deliver a highly specific saRNA that reactivates the endogenous p21 (CDKN1A) gene. By upregulating p21 protein expression in target ocular cells, RAG-1C is designed to induce cell cycle arrest, effectively inhibiting cellular proliferation and myofibroblast transformation without cellular toxicity. Administered as an intravitreal injection (IVT), RAG-1C offers the potential for long-lasting anti-fibrotic protection through a single intraoperative administration.

The upcoming Phase I clinical trial will evaluate s the safety, tolerability, pharmacokinetics, and preliminary efficacy of RAG-1C in patients undergoing surgery for retinal detachment who are at high risk of developing PVR.