A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
Phase of Trial: Phase II
Latest Information Update: 01 Sep 2015
At a glance
- Drugs Idebenone (Primary)
- Indications Leber's hereditary optic atrophy
- Focus Registrational; Therapeutic Use
- Acronyms RHODOS-OFU
- Sponsors Santhera Pharmaceuticals
- 01 Sep 2015 According to a company media release, Santhera Pharmaceuticals re-filed a Marketing Authorization Application (MAA) and in June 2015, the CHMP recommended granting a marketing authorization for Raxone for the treatment of visual impairment in adolescent and adult patients with LHON.
- 22 Jan 2013 New trial record
- 18 Jan 2013 Santhera received a negative opinion on its MAA for Raxone but is requesting a re-examination of the opinion, according to a media release.