Stargardt’s treatment gains orphan drug status in Europe

The European Medicines Agency has granted orphan drug designation to a novel topical treatment shown to improve vision in Stargardt’s disease.

Developed by Makindus, the treatment has already received orphan drug status from the U.S. FDA. Makindus plans to start Phase 3 trials in the United States by the end of the year.

"Stargardt's patients present a unique challenge for retinal specialists and we are looking forward to conducting the largest clinical trial that has ever been done in this orphan indication,” said David Eveleth, PhD, clinical head for Makindus.

The company is currently seeking corporate partners to help fund development of the new drug.