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.
Select a button below to view the list of FDA events for that drug.
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:
- April 15, 2026
- Indication:
- Next-generation corneal cross-linking therapy for the treatment of keratoconus.
Announcement
Glaukos Corporation announced today the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Epioxa™ HD / Epioxa™ ("Epioxa") for the treatment of keratoconus, a rare, sight-threatening disease that is currently far too often undiagnosed and untreated.
AI Summary
Glaukos Corporation announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent HCPCS J‑code for Epioxa™ HD / Epioxa™ to treat keratoconus. The new J‑code, J2789, will become effective July 1, 2026. Epioxa is intended for use in patients with keratoconus, a rare and potentially sight‑threatening corneal condition that is often undiagnosed and undertreated. Glaukos says the permanent J‑code identifies Epioxa specifically for clinician‑administered treatment.
J‑codes are reported by U.S. healthcare providers and used by government and commercial payers to standardize billing and reimbursement for drugs given in clinical settings. Assigning J2789 should help streamline claims, improve coding consistency, and may support coverage and access for patients receiving Epioxa through healthcare professionals. For more information, consult Glaukos or payer guidance when the code becomes effective.
Read Announcement- Drug:
- Epioxa
- Announced Date:
- October 20, 2025
- Indication:
- Next-generation corneal cross-linking therapy for the treatment of keratoconus.
Announcement
Glaukos Corporation announced today the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ ("Epioxa") New Drug Application (NDA).
AI Summary
Glaukos Corporation announced the U.S. FDA approved its New Drug Application (NDA) for Epioxa™ HD and Epioxa™, the first and only incision-free, topical drug therapy for keratoconus. This rare, sight-threatening disease can lead to vision loss if untreated. Epioxa uses oxygen-enriched riboflavin solutions activated by UV light and works without removing the corneal epithelium. This design aims to reduce pain, streamline the procedure, and speed recovery while delivering strong clinical outcomes.
The FDA greenlight follows two Phase 3 trials with over 400 patients, which met all primary endpoints and showed favorable safety. Epioxa is expected to be available in the U.S. in the first quarter of 2026. Glaukos plans to boost patient awareness, expand access programs, offer co-pay assistance, and launch early screening initiatives to tackle underdiagnosis and improve treatment rates.
Read Announcement- 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.
Read Announcement
IDose TR FDA Regulatory 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 28, 2026
- Indication:
- Glaucoma
Announcement
Glaukos Corporation announced that the U.S. Food and Drug Administration (FDA) has approved an NDA labeling supplement allowing for re-administration of iDose® TR using a repeat treatment protocol.
AI Summary
Glaukos announced the FDA has approved an NDA labeling supplement that allows re-administration of iDose® TR using a repeat treatment protocol. The change lets physicians offer repeated intracameral implants over time, potentially expanding access for patients who need ongoing intraocular pressure (IOP) control. Glaukos CEO Thomas Burns said the labeling enhancement should help expand access and give doctors greater flexibility, and that it validates iDose TR’s safety profile while addressing demand for sustained procedural alternatives to eye drops.
iDose TR is a travoprost intracameral implant indicated to lower IOP in open-angle glaucoma or ocular hypertension. It is placed in the eye under aseptic conditions. Clinicians should monitor implant position and use caution in eyes with narrow angles. Common adverse reactions (2–6%) include increased IOP, iritis, dry eye, visual field changes, eye pain, redness, and reduced visual acuity. Iris pigmentation may increase and can be permanent.
Read Announcement- 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.
Read Announcement
