GenSight Biologics Wins FDA Orphan Drug Designation for GS030

Paris-based GenSight Biologics has gained orphan drug designation from the FDA for its drug candidate GS030 for the treatment of retinitis pigmentosa.

GS030 is currently undergoing a Good Laboratory Practices regulatory toxicity study and is expected to enter a Phase I/II clinical trial in retinitis pigmentosa patients in the third quarter of  2017, subject to toxicity results and future regulatory review.

GS030 received an advanced therapy medicinal product classification in Europe in September 2016.