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Isarna receives orphan drug designation for ISTH0036 in Europe

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Isarna Therapeutics announced that the European Medicines Agency has granted orphan drug designation for ISTH0036 for prevention of scarring after glaucoma filtration surgery.

A phase 1 trial of the drug began in April for patients with advanced stage glaucoma who have undergone glaucoma filtration surgery.

ISTH0036 is a locked nucleic acid-modified antisense oligonucleotide that targets TGF-ß2, according to the announcement, and elevated TGF-ß2 in eyes of patients with glaucoma affects the optic nerve head, leading to fibrosis and scarring after glaucoma filtration surgery.

With the designation, Isarna becomes eligible for fee reductions and incentives, including 10-year market exclusivity for ISTH0036, according to the announcement.

The drug is investigational in the U.S. where it has not been approved by the FDA and is not for commercial sale.