EU/3/14/1400: Orphan designation for the treatment of neurotrophic keratitis

(1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine


On 16 December 2014, orphan designation (EU/3/14/1400) was granted by the European Commission to MIMETECH S.r.l., Italy, for (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine for the treatment of neurotrophic keratitis.

The sponsorship was transferred to Orphan Europe SARL, France, in May 2018.

Key facts

Active substance
(1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine
Intended use
Treatment of neurotrophic keratitis
Orphan designation status
EU designation number
Date of designation
Orphan Europe SARL
Immeuble le Wilson
70 Avenue du General De Gaulle
F-92800 Puteaux
Tel. +33 1477 39527

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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