We first heard of Holoclar’s breakthrough success in 2015, when it received recommendation for approval by the European Medicines Agency. Holoclar, developed by Italian pharmaceutical company Chiesi Farmaceutici, is based on ex vivo expanded autologous human corneal epithelial cells, which contain limbal stem cells, and which repair the cornea after injury.
Now, Holoclar has received another round of positive news: the therapy was just recommended for approval by the UK’s National Institute for Health and Care Excellence (NICE), who green lit it for use on the NHS for threatment in people with moderate to severe limbal stem cell deficiency after eye burns.
The therapy has been a long, collaborative effort between Professors Michele De Luca and Graziella Pellegrini, both from the Centre for Regenerative Medicine at the University of Modena and Reggio Emilia and Andrea Chiesi, Director of R&D Portfolio Management of Chiesi Farmaceutici S.p.A.
In healthy individuals, limbal stem cells cells are located within a narrow section of the cornea, conjunctiva and the sclera. They are the source of new corneal epithelium cells. In individual with severe limbal stem cell deficiency (LSCD), cells from the conjunctiva have migrated to the surface of the cornea, resulting in new blood vessels creation, chronic inflammation and scarring, resulting in attenuation or a complete loss of vision.
In its recommendation, NICE clarified the therapy is to be used under the following specific conditions:
- it is only used to treat 1 eye and
- people have already had a conjunctival limbal autograft or
- there is not enough tissue for a conjunctival limbal autograft or it is contraindicated and
- the company provides it with the discount agreed in the patient access scheme.
Full recommendation details are given here.
For more on Chiesi Farmaceutici, go here.