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FDA grants orphan drug designation for ISTH0036 to Isarna

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The FDA has granted orphan drug designation for ISTH0036 for the prevention of scarring after glaucoma filtration surgery, Isarna Therapeutics announced in a press release.

The FDA decision follows recent EMA orphan drug designation for ISTH0036, which is currently in phase 1 evaluation in glaucoma patients, the release said.

“Both European Medicines Agency and FDA decisions support the innovation required to improve standard of care of advanced-stage glaucoma patients. Isarna continues to gather insight into the molecular role played by transforming growth factor beta in glaucoma pathophysiology and we value the recognition from both agencies for ISTH0036’s potential,” Philippe P. Calais, PhD, president and CEO of Isarna, said in the release.

Under the U.S. Orphan Drug Act, the designation will provide a 7-year exclusive marketing period for the drug in addition to certain incentives and tax credits for development costs, the release said.