Spark Gene Therapy Improves Vision, At Least in Short Term: FDA
Spark Therapeutics’s experimental gene therapy for a rare inherited form of blindness improves vision, though it is unclear whether the benefit lasts over time, according to a preliminary review by the FDA, as reported in PharmaLive.
The therapy, Luxturna, or voretigene neparvovec, would be the first-ever gene therapy for any inherited disease to be approved in the United States.
The FDA’s review, posted on Tuesday on the agency’s website, comes two days ahead of a meeting of outside advisers who will discuss the treatment and recommend whether it should be approved.
Michael Yee, an analyst at Jefferies, said the FDA documents “look fairly benign and as expected,” and that he expects the advisory panel is likely to vote in favor of approval.
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