EU approves Holoclar for eye damage-Chiesi
The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004, to Holoclar, from Chiesi, an advanced therapy based on autologous stem cells and capable to restore the eyesight of patients with severe cornea damage. Holoclar is a graft of epithelium taken from the patient that forms a contact lens, providing a transparent cornea plus full recovery of visual acuity, without risk of rejection. It is the the first stem cell-based medicinal product.
The approved indication is: '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.'
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.