Glaukos
1 products tracked · names used in filings: Glaukos, GLAUKOS Corp
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Epioxa: PDUFA target action date
GLAUKOS Corp (GKOS); NDA; status: set; "Recent updates in our pipeline include: ✓ Announced FDA acceptance for review of NDA submission for Epioxa (Epi-on) (February 2025) o Completed successful pre-approval inspection (PAI) at Burlington, MA facility (2Q 2025) o Completed productive post mid-cycle review meeting with the FDA (2Q 2025) o Advancing…"; filed 2025-07-30 · source
FDA approves Epioxa Hd/Epioxa Kit (riboflavin 5'-phosphate sodium): new formulation or manufacturer
Glaukos; NDA219910; New formulation or manufacturer; solution/drops · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Epioxa Hd/Epioxa Kit riboflavin 5'-phosphate sodium | Approved | 2025-10-17 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.