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Glaukos Receives FDA Approval for Epioxa

Shots:

  • Glaukos reported the US FDA approval of Epioxa HD/Epioxa, an incision-free, topical drug therapy for keratoconus, offering a non-surgical alternative to traditional corneal cross-linking
  • The approval was based on two P-III pivotal studies (>400 pts) that met its pre-specified 1EPs strong efficacy and safety; Epioxa uses a UV-activated, oxygen-enriched formulation that preserves the corneal epithelium, significantly reducing pain and recovery
  • Epioxa is expected to launch in Q1’26, and Glaukos plans to provide additional details on the FDA approval of Epioxa and related matters as part of its upcoming Q3’25 financial results conference call

Ref:  Glaukos | Image:  Glaukos | Press Release

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