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Neurophth Completes Phase I/II Trial Enrollment for LHON Gene Therapy

NEW YORK – Neurophth on Monday said it has completed enrollment of its Phase I/II trial of Opvika (esonadogene imvoparvovec), the firm's investigational gene therapy for Leber hereditary optic neuropathy (LHON).

Opvika is designed as a treatment for LHON, a rare and inherited mitochondrial disorder associated with vision loss, that is specifically caused by mutations in the mitochondrial gene ND4 by delivering a functional copy of that gene.

Wuhan, China-based Neurophth is evaluating the safety and efficacy of Opvika in a single-arm Phase I/II trial in the US in which patients receive a single injection of the treatment to one eye.

Neurophth has been granted orphan drug designation by the US Food and Drug Administration and the European Medicines Agency. 

Neurophth has also completed enrollment for a Phase III trial of Opvika in China.