Santhera Initiates Collaboration with the European Vision Institute Clinical Research Network in LHON
Santhera Pharmaceuticals announced that it has initiated a collaboration with the European Vision Institute Clinical Research Network (EVICR.net) to assess the natural course of Leber's Hereditary Optic Neuropathy (LHON). Data from this collaboration is intended to be included in a marketing authorization application (MAA) for Raxone® (idebenone) in Europe.
Under the collaboration, Santhera will receive data on the change in vision over time in untreated LHON patients from selected EVICR.net centers. This data will be compared to the vision outcomes data currently being collected from physicians around the world who are treating LHON patients with Raxone® in clinical practice.
"Lack of natural history data is a general shortcoming in clinical research of rare diseases and a limitation in the development of orphan drugs", commented Thomas Meier, CEO of Santhera. "We have initiated this collaboration with EVICR.net to increase our understanding of changes in vision in LHON patients, including spontaneous recovery after severe vision loss. We expect to integrate these data as a comparator group in a revised MAA for Raxone® in the treatment of LHON that we plan to submit as early as the first quarter next year."
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