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Krystal Biotech Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for the Treatment of Neurotrophic Keratitis
PITTSBURGH, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug
About this update from Krystal Biotech, Inc.
[{"type":"text","content":"PITTSBURGH, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company’s redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK). “Receiving a platform technology designation from the FDA is a tremendous milestone for our development team and Krystal, both as recognition of the reproducibility and scalability of our HSV-1 gene delivery platform and for the potential product development benefits it may provide,” said Suma Krishnan, President of Research and Development at Krystal Biotech. “We are excited to work with the FDA under this program to identify potential efficiencies, including opportunities to leverage our prior experience with FDA-approved VYJUVEK® (beremagene geperpavec-svdt), to accelerate the development of our genetic medicines pipeline, starting with KB801 for the treatment of NK.” The FDA’s platform technology designation program is intended to provide efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies. Potential benefits of the designation may include early and more frequent engagement with the FDA during clinical development as well as the opportunity to leverage manufacturing and nonclinical safety data from a prior product using the designated platform technology, such as VYJUVEK, in submissions to the FDA. The FDA may also consider previous inspectional findings related to the manufacture of a drug that incorporates the designated platform technology. To be eligible for a platform technology designation, a technology must be well-understood and reproducible, used in an FDA-approved drug or biologic product, such as VYJUVEK, have the potential to support the development of multiple drugs or biologic products without compromising quality, manufacturing, or safety, and have a reasonable likelihood to bring significant efficiencies to the development or manufacturing process as well as to the FDA review process. Drug product applications that are then recognized b...