Chiesi's Holoclar, the first stem-cell therapy to be cleared by European regulators, has received a green light for use on the NHS in England and Wales to treat a rare sight condition.
The National Institute for Health and Care Excellence has now published final guidelines backing Holoclar as an option to treat adults with moderate to severe limbal stem cell deficiency (LSCD) after eye burns.
However, the guidelines state the therapy can only be used to treat one eye and in those who have already had a conjunctival limbal autograft, or there is not enough tissue for a conjunctival limbal autograft or it is contraindicated.
Holoclar is now also recommended in adults with moderate to severe LSCD after eye burns for treating both eyes only in the context of research, and when there is not enough tissue for a conjunctival limbal autograft.
LSCD is a seriously debilitating condition affecting one or both eyes, most commonly from chemical or physical ocular burns. If left untreated, it can cause chronic pain, burning, photophobia, inflammation, corneal neovascularisation, stromal scarring and the reduction or complete loss of vision.
Holoclar uses a patient’s own stem cells to regenerate and repair damaged eye tissue and is the first advanced therapy medicinal product containing stem cells as the active substance to win approval in Europe, back in 2015. It also won the UK Prix Galien Orphan Product award for innovation and research in 2016.
Chiesi says it is extremely pleased with NICE’s decision, which will reduce the need for external donors and damage to the donor eye.
“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,” said Chiesi's UK managing director Tom Delahoyde.