Glaukos Announces FDA Acceptance of NDA Submission for Epioxa™
Glaukos Corporation (GKOS)
Last glaukos corporation earnings: 2/27 04:15 pm
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Source: Business Wire
PDUFA Date Set for October 20, 2025 ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced it has received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a sight-threatening corneal disease, is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review of the Epioxa NDA is set for October 20, 2025. This date reflects a standard 10-month review period, which is consistent with the company’s expectations.“The acceptance of the Epioxa NDA represents another important step in being able to provide keratoconus p
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News
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- Glaukos (NYSE:GKOS) had its "buy" rating reaffirmed by analysts at Citigroup Inc..MarketBeat
GKOS
Earnings
- 10/29/25 - Beat
GKOS
Sec Filings
- 12/15/25 - Form 4
- 12/15/25 - Form 4
- 12/15/25 - Form 4
- GKOS's page on the SEC website