The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine ATSN-201 for the treatment of Retinoschisis. The public consultation will take place from 8 June to 8 July 2026.
For each clinical trial application for the use of a genetically modified organism, the government organises a thirty-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can give your opinion on this clinical trial application with a genetically modified medicine.
X-linked retinoschisis (XLRS) is an inherited eye disease that affects the retina and can induce vision problems. The disease is caused by mutations in the retinoschisin gene (RS1). There is currently no approved treatment for the underlying genetic cause of XLRS. Eye drops are sometimes prescribed to reduce small accumulations of fluid in the retina.
In this clinical trial, the investigational medicinal product ATSN-201 will be administered subretinally into one eye (unilaterally) or both eyes (bilaterally) to children aged ≥ six years and adults with RS1-associated XLRS. ATSN-201 is a gene therapy being developed to introduce the functional human RS1 gene into the photoreceptors in the eye, thereby restoring vision in patients with XLRS or slowing its decline.
The aim of this trial is to assess the safety and efficacy of ATSN-201 in children aged ≥ six years and adults with RS1-associated XLRS.
The clinical trial will take place at the University Hospital in Ghent.
How to give your opinion?
The public consultation runs from 8 June to 8 July 2026 inclusive. You can access the various data in the application file, as well as an online form to send your comments or ask your questions.
General information on OGM : consultations publiques | SPF Santé publique.