Orphan Europe’s parent company, Recordati, have announced that the European Union Commission have granted the European marketing authorisation for its orphan medicinal product, Cystadrops®. This is the first eye-drop solution containing cysteamine hydrochloride approved in the European Union for “the treatment of corneal crystal deposits in adults and children from 2 years of age with cystinosis”.
The formulation of Cystadrops® allows four instillations per day which should considerably favour patient’s compliance with the treatment and decrease ophthalmic complications for all patients suffering from cystinosis.
“We are extremely pleased that the European Commission has granted the marketing approval for Cystadrops®, an important therapeutic solution for the ophthalmic complications affecting cystinosis patients” declared Andrea Recordati, Vice Chairman and Chief Executive Officer. “The product had already been made available to patients through early access programs in Europe and in some other countries and therefore many patients affected by the ocular manifestations of cystinosis have already been able to benefit from treatment with Cystadrops®.”