Holoclar, a stem cell therapy from Chiesi, has been issued final guidelines from NICE as an option to treat adults with moderate to severe limbal stem cell deficiency (LSCD) after eye burns, while being included on the NHS in England and Wales.
The guidelines outline that the stem cell therapy can only be used in the following conditions:
- Only for the treatment of one eye and for patients who have had a conjunctival limbal autograft
- For patients in whom there is not enough tissue for a conjunctival limbal autograft
- For patients in whom the tissue for the conjunctival limbal autograft is constrained
The product was the first to include stem cells as the active ingredient and win European approval in 2015. It was also awarded the UK Prix Galien Orphan Product award for innovation and research in 2016.
The Chiesi UK managing director, Tom Delahoyde, stated:
“We are delighted that NICE has recommended that eligible patients have access to this personalised and regenerative medicine for a rare and seriously debilitating orphan condition”