Holoclar for treating limbal stem cell deficiency after eye burns

2.1 The technology is ex vivo expanded autologous human corneal epithelial cells containing stem cells (Holoclar, Holostem Terapie Avanzate). It is a treatment used in the eye to replace damaged cells on the corneal surface.

2.2 It has a conditional marketing authorisation for 'the treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least 2 corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns'. At least 1 mm² to 2 mm² of undamaged limbus is needed for biopsy before it can be used.

2.3 For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.4 The exact dosage depends on the size of the corneal surface: the recommended dose is 79,000 to 316,000 cells/cm². A biopsy is first taken of the eye, which needs at least 1 mm² to 2 mm² of undamaged tissue. The treatment is then implanted in the eye.

2.5 According to the company's submission, a single treatment for 1 eye costs £80,000 excluding VAT. The company has a commercial arrangement. This makes Holoclar available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.