Glaukos Achieves Regulatory and Commercial Milestones

The ophthalmic medical technology company Glaukos Corporation has delivered a dual update, announcing both a significant regulatory approval and strong preliminary financial results. The developments highlight the firm's progress in advancing its glaucoma treatment portfolio and its commercial momentum.

Ahead of its official earnings release, Glaukos reported unaudited net sales for the fourth quarter of 2025 of approximately $143 million. This figure represents a substantial 36% increase compared to the same period in the prior year. The performance was led by the U.S. glaucoma business, which generated $86 million. Within that segment, the iDose TR implant contributed an estimated $45 million. The company's international glaucoma and corneal health segments also demonstrated strength, posting sales of $33 million and $24 million, respectively.

FDA Approval Expands iDose TR Treatment Protocol

In a separate but concurrent announcement, the U.S. Food and Drug Administration (FDA) granted approval for the repeat administration of the iDose TR sustained-release implant. This decision marks a strategic expansion for the travoprost-eluting device, which is designed to lower intraocular pressure in glaucoma patients. The approval is supported by three-year long-term clinical data confirming corneal safety in patients meeting specific endothelial cell density parameters. This regulatory milestone allows physicians to consider the implant for longer-term management, as it delivers medication continuously directly within the eye.

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Confirmed Outlook and Infrastructure Investment

Looking ahead, Glaukos has reaffirmed its full-year 2026 net sales guidance, projecting revenue in the range of $600 million to $620 million. To support this anticipated growth and future therapies—including Epioxa, which received FDA approval in October 2025—the company is advancing the construction of a new research and manufacturing facility in Alabama. This expansion is intended to secure production capacity for upcoming pipeline products.

Key Financial Highlights:
* Q4 2025 Net Sales: ~$143 million (a 36% year-over-year increase)
* Primary Growth Driver: iDose TR implant, contributing ~$45 million in revenue
* 2026 Annual Forecast: Confirmed at $600 to $620 million

Glaukos is scheduled to report its final, audited financial results for the fourth quarter and full year 2025 after the U.S. market closes on Tuesday, February 17, 2026. That detailed report will provide investors with further insights into margin progression and operational updates regarding the new production site.