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Press Release

NICE recommends Holoclar? (ex vivo expanded autologous human corneal epithelial cells containing stem cells) for the treatment of moderate to severe limbal stem cell deficiency after eye burns

Posted on: 25 Aug 17

First advanced therapy medicinal product containing stem cells to receive a Marketing Authorisation in Europe[1] recommended for use in eligible NHS patients


Manchester (UK), 24 August 2017 - Chiesi UK today announced that the National Institute for Health and Care Excellence (NICE) has published final guidance recommending Holoclar as an option in adults with moderate to severe limbal stem cell deficiency (LSCD) after eye burns, if it is only 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). NICE also indicated that Chiesi should provide Holoclar in line with the discount agreed in the patient access scheme.[2]


Holoclar is now also recommended by NICE 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.


Chiesi's UK Managing Director Tom Delahoyde said, “Chiesi is extremely pleased that patients with LSCD can now have access to this innovative and breakthrough medicine on the NHS in England and Wales, reducing the need for external donors and damage to the donor eye. Today’s recommendation is a culmination of many years of research and development and 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.”


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 receive a Marketing Authorisation in Europe (granted in February 2015).1 Holoclar is licensed for the treatment of adults with moderate-to-severe LSCD (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns. Holoclar also won the prestigious UK Prix Galien Orphan Product award for innovation and research in 2016.


LSCD is a rare and seriously debilitating condition affecting one or both eyes; left untreated it results in chronic pain, burning, photophobia, inflammation, corneal neovascularisation, stromal scarring and the reduction or complete loss of vision.[3],[4] Chemical and physical ocular burn injuries are thought to be the most common cause of LSCD.[5] Those likely to benefit from treatment with Holoclar include workers injured in industrial accidents (e.g. alkali/acid splash injuries) and military personnel injured in action (e.g. due to explosive devices). It is estimated that the maximum UK prevalent population eligible for treatment with Holoclar is 121 patients.[6]


Once NICE recommends a treatment 'as an option' in final guidance, the NHS must make sure it is available within three months (unless otherwise specified) of its date of publication.

Editor's Details

Mike Wood

Last updated on: 25/08/2017

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