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Ractigen Cleared for First saRNA Clinical Trials in PVR Patients

The U.S. Food and Drug Administration has cleared an Investigational New Drug application for RAG-1C, a first-in-class small activating RNA therapy designed to treat Proliferative Vitreoretinopathy. This approval follows a similar regulatory green light in China, marking a significant step toward addressing a condition that currently lacks any pharmacological treatment options.

Ractigen Cleared for First saRNA Clinical Trials in PVR Patients
Photo: Bio & News

Proliferative Vitreoretinopathy remains a primary cause of surgical failure following retinal detachment, affecting up to 40% of severe ocular trauma cases. Current clinical standards rely exclusively on surgical intervention, which is frequently complicated by high recurrence rates. RAG-1C aims to shift this dynamic by utilizing Ractigen's proprietary LiCO™ platform to reactivate the endogenous p21 gene. By inducing cell cycle arrest in retinal pigment epithelium cells, the therapy seeks to prevent the scarring and membrane formation that lead to permanent vision loss.

Dr. Long-Cheng Li, founder and CEO of Ractigen Therapeutics, stated that the dual regulatory approval validates the safety and therapeutic potential of their RNA activation technology. The upcoming Phase I trial will assess the drug's safety and preliminary efficacy in high-risk patients during routine retinal detachment surgery. Delivered via intravitreal injection, the treatment is designed for a single administration approach, offering a localized, non-toxic alternative to existing surgical limitations.

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