The European Union Commission grants marketing authorization for Cystadrops 3.8mg/mL. for treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.- Recordati

Recordati announces that the European Union Commission has granted the European marketing authorization for its orphan medicinal product Cystadrops 3.8mg/mL. Cystadrops is the first eye-drop solution containing cysteamine hydrochloride approved in the European Union for “the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis". The European Commission granted Cystadrops orphan drug designation in November 2008.

Cystinosis is a rare congenital lysosomal storage disorder recognized as a severe life threatening condition. Cystinosis is characterized by an accumulation of cystine crystals which negatively affects all organs in the body, especially the kidneys and eyes. The cystine crystal deposits start in the cornea, leading progressively to increased sensitivity to light (photophobia), corneal surface deterioration (keratopathy) and loss of vision. Cystinosis benefits from systemic treatment with cysteamine orally administered. However, oral cysteamine does not adequately address ocular cystinosis because of the non-vascularization of cornea. Without a proper, continued, local eye treatment, cystine crystals accumulate in the cornea, leading to severe ophthalmic consequences and possibly to blindness in the long term.

Cystadrops eye-drop solution has been developed specifically for cystinosis patients by Orphan Europe (Recordati Group)and is the first pharmaceutical product to be approved in the European Union for this indication.