JUN 02, 2015
The European Medicines Agency has granted orphan drug designation to a potentially safer alternative to traditional anti-fibrotic therapies, a human anti-transforming growth factor-beta2 antibody.
ISTH0036 is currently the only compound in clinical development worldwide that directly targets TGF- β2, which is seen as a core driver of glaucoma pathophysiology and the scarring process that occurs after filtration surgery.
In preclinical studies, ISTH0036 showed it could prevent scarring after filtration surgery in rabbits. With EMA Orphan Drug Designation, Isarna is eligible for development fee reductions and incentives including 10-year market exclusivity for ISTH0036.
Isarna Therapeutics, the company developing the agent, began in April 2015 a phase 1 study in patients with advanced-stage glaucoma.