FDA Awards Glaucoma Drug Orphan Status
The FDA has granted orphan drug status to Isarna Therapeutics' ISTH0036 for the prevention of scarring after glaucoma filtration surgery.
The designation, announced June 10 by the German drugmaker, follows orphan drug designation last month by the European Medical Agency. ISTH0036, which is injected into the eye, is currently being evaluated in a Phase I trial with advanced-stage glaucoma patients in Germany.
Isarna President and CEO Philippe Calais saysthat the drug is the first compound to target a protein that is the root cause of glaucoma.
“What we expect to show is that the compound helps prevent the postsurgical rise of intraocular pressure” and maintain patients' vision longer, Calais says. The same technology may lead to development of other ocular treatments in the future, he adds.
Some 40,000 surgeries for advanced-stage glaucoma are performed annually in the U.S., according to Calais.
If approved by the FDA, ISTH0036 will have seven years of market exclusivity. The orphan designation also entitles Isarna to tax credits for development costs.
The drugmaker has created a U.S. subsidiary in New York. — Charlotte Astor