This section highlights FDA-related milestones and regulatory updates for drugs developed by Glaukos (GKOS).
Over the past two years, Glaukos has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Epioxa and iDose. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Epioxa - FDA Regulatory Timeline and Events
Epioxa is a drug developed by Glaukos for the following indication: Next-generation corneal cross-linking therapy for the treatment of keratoconus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Epioxa
- Announced Date:
- December 23, 2024
- Indication:
- Next-generation corneal cross-linking therapy for the treatment of keratoconus.
Announcement
Glaukos Corporation announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a progressive, sight-threatening corneal disease.
AI Summary
Glaukos Corporation announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy designed to treat keratoconus—a progressive, sight-threatening corneal disorder. If approved, this therapy would be the first FDA-approved, non-invasive treatment that preserves the corneal epithelium, the outer layer of the eye, eliminating the need for its removal prior to treatment. Epioxa™ uses a unique drug formulation, a stronger UV-A irradiation protocol, and supplemental oxygen to enhance cross-linking, aiming to reduce procedure times, improve patient comfort, and shorten recovery times. The NDA includes positive data from two Phase 3 trials, both meeting their primary efficacy endpoints while showing favorable safety and tolerability profiles. This milestone underscores Glaukos’ commitment to advancing innovative treatment options for patients suffering from keratoconus.
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iDose TR - FDA Regulatory Timeline and Events
iDose TR is a drug developed by Glaukos for the following indication: Glaucoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- iDose TR
- Announced Date:
- January 14, 2025
- Indication:
- Glaucoma
Announcement
Glaukos Corporation announced several positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform,
AI Summary
Glaukos Corporation shared positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform. A new 36‐month follow-up analysis of two Phase 3 pivotal trials showed that about 70% of patients receiving iDose TR maintained controlled intraocular pressure (IOP) on the same or fewer topical medications compared to 58% of timolol control patients. The implant also continued to show excellent tolerability and a good safety profile through 36 months.
The company has also started a Phase 2b/3 clinical program for iDose TREX, a next-generation device similar to the original but with nearly twice the drug capacity. Additionally, a 6-month follow-up in a Phase 4 study indicated that when combined with cataract surgery, iDose TR achieved an average IOP reduction of 11.3 mmHg (44%) from baseline. These findings support Glaukos’ mission to offer a sustained, effective treatment option for patients with glaucoma or ocular hypertension.
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