Spark Therapeutics Wins U.S. Approval for Blindness Gene Therapy

Spark Therapeutics Inc. won U.S. approval for a first-of-its-kind therapy for a specific gene mutation that causes a form of inherited vision loss.

The Food and Drug Administration cleared the drug Luxturna, the first approved product for Philadelphia-based Spark.

“Today’s approval marks another first in the field of gene therapy ‒ both in how the therapy works and in expanding the use of gene therapy beyond the treatment of cancer to the treatment of vision loss ‒ and this milestone reinforces the potential of this breakthrough approach in treating a wide-range of challenging diseases,” FDA Commissioner Scott Gottlieb said in ...