Holoclar
What Holoclar is used for
Treatment of adult patients with moderate to severe limbal stem cell deficiency (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. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Advanced therapy: a gene, cell or tissue-engineered medicine.
Key facts
- Brand
- Holoclar
- Active substance
- ex vivo expanded autologous human corneal epithelial cells containing stem cells
- Disease area
- Stem Cell Transplantation; Corneal Diseases
- Medicine group
- Ophthalmologicals
- ATC code
- S01XA19
- Marketing authorisation holder
- Holostem s.r.l.
- Authorised in the EU since
- 2015
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Holoclar used for?
Treatment of adult patients with moderate to severe limbal stem cell deficiency (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. A minimum of 1-2 mm2 of undamaged limbus is required for biopsy.
What is the active substance in Holoclar?
Holoclar contains ex vivo expanded autologous human corneal epithelial cells containing stem cells.
Who makes Holoclar?
The EU marketing authorisation holder is Holostem s.r.l..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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