Makindus announced that it has received orphan drug designation from the FDA for MI-100 for the treatment of Stargardt’s Disease.

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Stargardt’s, also known as juvenile macular degeneration, is a genetic disease caused by mutations in the ABCA4 gene. Disease onset is usually around 8–12 years old with significant variability in the speed of disease progression. Makindus plans to initiate a Phase 3 confirmatory trial early 2015 and may begin enrolling patients as early as March 2015.

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