The European Commission has given the green light to Chiesi’s Holoclar - which the Italian company says is the first stem-cell therapy to be approved in the western world - for a rare eye condition.
Conditional marketing authorisation has been granted to Holoclar, the first advanced therapy medicinal product (ATMP) containing stem cells, for the treatment of moderate-to-severe limbal stem cell deficiency due to physical or chemical burns to the eyes in adults. The approval was expected, given that the European Medicines Agency’s Committee for Medicinal Products for Human Use, issued a positive opinion in December.
The therapy is manufactured by Holostem Advanced Therapies, a spin-off of the University of Modena and Reggio Emilia. The latter’s co-founder Graziella Pellegrini explained that Holoclar is a graft of epithelium taken from the patient that looks like a contact lens which is then transplanted, allowing them to obtain a long-term transparent cornea and full recovery of visual acuity, without any rejection concerns.
Chiesi said Holoclar will “in the near future will be available to all European patients who have suffered workplace injuries, domestic accidents or assault with chemical agents”.