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This drug is an advanced therapy medicinal product (ATMP) consisting of a tissue-engineered artificial cornea. It is composed of two distinct allogeneic cell types: expanded limbal stem cells, which form the epithelial layer, and expanded corneal-differentiated adult keratocytes, which populate the stromal layer. These cells are integrated into a nanostructured biological matrix, typically composed of fibrin and agarose. Developed by the Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía Oriental - Alejandro Otero (FPS), this product is designed to treat severe, refractory trophic corneal ulcers. The mechanism of action involves the restoration of the corneal surface through the delivery of regenerative stem cells and the provision of a structural scaffold that facilitates stromal healing and epithelialization, thereby preventing perforation and improving visual outcomes in patients who have failed conventional therapies.
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