Sensory augmentationBiotech02 sources

iRegene photoreceptor cell therapy cleared for trials in US and China

Fundus photograph of an eye with advanced retinitis pigmentosa, showing dark pigment clumps scattered across the retina around a pale optic disc and thinned blood vessels.

Christian Hamel, via Wikimedia Commons (CC BY 2.0)CC BY

iRegene Therapeutics, based in Chengdu, announced on 29 September 2026 that regulators in both China and the United States have cleared its cell therapy NouvSight001 for clinical trials in retinitis pigmentosa. China’s National Medical Products Administration cleared a Phase I/III trial. The US Food and Drug Administration cleared a Phase I/II trial and granted a special exemption, which the company does not detail.

Retinitis pigmentosa is a group of inherited diseases in which the retina’s light-sensing photoreceptors degenerate, leading towards blindness. According to iRegene it affects about 1.5 million people worldwide. The only approved therapy works only for patients with mutations in both copies of the RPE65 gene, a small fraction of cases.

NouvSight001 aims to replace the lost photoreceptors with new cells rather than correct a specific gene, so it is not restricted to one genotype. It is allogeneic and off-the-shelf, made with the company’s “AI + Chemical Induction” platform, which uses artificial intelligence and small molecules to steer cell fate. The route of delivery has not been disclosed. NouvSight001 received FDA orphan drug designation in 2024.

Sources

  1. [1]iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis PigmentosaiRegene Therapeutics via PR Newswire··Press release
  2. [2]iRegene’s NouvSight001 Cleared for US and China RP TrialsBioPharm International··Article