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Injection

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Lebers hereditary optic atrophy Clinical stage: Phase 3 Modality: AAV gene therapy Mechanism & Target: Adeno-associated virus based gene therapy Route & form: Subretinal / intravitreal injection Differentiation: Designed to treat Leber’s Hereditary Optic Neuropathy (LHON) with ND4-mutation.
Manufacturer #39670

A late-stage clinical biopharmaceutical company focused on ophthalmology. Developing a gene therapy therapeutic targeting ophthalmology with global development focus. Pipeline positioned for regulatory advancement in key markets.
 

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