Stargardt’s disease treatment gains orphan designation

Doylestown, PA-Makindus has received orphan designation for its lead product, MI-100, from the FDA’s Office of Orphan Products Development for the treatment of Stargardt’s disease.

“The FDA’s approval for our orphan drug designation application for (our Stargardt’s disease treatment) is a key milestone for the company and we look forward to initiating our phase III confirmatory trial early next year,” said Manohar Katakam, president and chief executive officer of Makindus.

The company acquired intellectual property and associated clinical data supporting multiple ocular indications through a licensing deal that was closed in 2013.

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