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FDA OKs Risky, Pioneering OSK Rejuvenation Trial with Sinclair’s ER-100

The U.S. Food and Drug Administration has cleared an investigational new drug application for Life Biosciences' ER‑100, a viral gene‑therapy that delivers inducible Oct‑4, Sox‑2 and Klf‑4 (OSK) to the eye. The first‑in‑human trial will enroll a small cohort of patients with open‑angle glaucoma or non‑arteritic anterior ischemic optic neuropathy, aiming to achieve partial cellular reprogramming of retinal ganglion cells. Researchers hope the approach will rejuvenate damaged ocular tissue, while critics warn that the high‑risk, unproven technology could trigger safety issues such as tumor formation. The outcome may set a regulatory precedent for broader organ‑rejuvenation strategies.