Flavin mononucleotide

Glaukos submitted an NDA to the FDA for Epioxa, a next-gen corneal cross-linking therapy for keratoconus, aiming to be the first non-invasive treatment without epithelium removal.

Glaukos submits NDA to FDA for Epioxa™, a non-invasive corneal cross-linking therapy for keratoconus, aiming to reduce procedure times and improve patient comfort.

Glaukos plans to file for US FDA approval of Epioxa, its iLink corneal cross-linking therapy for keratoconus, after meeting primary endpoint in Phase III trial. The therapy showed significant change in maximum corneal curvature at 12 months compared to placebo, meeting FDA efficacy criteria. Epioxa, used during the cross-linking procedure, aims to strengthen corneal collagen fibers without removing the epithelium, offering an improvement over existing treatments like Photrexa.

Glaukos' Phase 3 confirmatory trial for Epioxa met primary efficacy endpoint, showing significant improvement in Kmax at 12 months, supporting NDA submission by end of 2024. Epioxa aims to be the first FDA-approved, non-invasive drug therapy for keratoconus.

Glaukos Corp's Phase 3 confirmatory trial for Epioxa (Epi-on) met primary efficacy endpoint, showing significant improvement in maximum corneal curvature (Kmax) at 12 months compared to sham/placebo-controlled arm, indicating potential to manage keratoconus progression. The treatment was well-tolerated, with no serious adverse events reported. These results support Glaukos' anticipated NDA submission for Epioxa by the end of 2024.