Glaukos receives EU certification for glaucoma surgery devices

ALISO VIEJO, Calif. - Glaukos Corporation (NYSE:GKOS), a $5.67 billion medical device company showing impressive revenue growth of nearly 24% over the last twelve months, has received European Union Medical Device Regulation certification for several of its micro-invasive glaucoma surgery devices, including iStent infinite and iStent inject W, the company announced in a press release.

These certifications mark Glaukos’s first approvals under the new EU regulatory framework, which establishes standards for quality, safety, and effectiveness of medical devices marketed in the European Union. The company maintains strong financial health with liquid assets significantly exceeding short-term obligations, as evidenced by a robust current ratio of 6.49, according to InvestingPro data.

"These important milestones will not only help us maintain and grow our presence in Europe but also advance and accelerate our broader Interventional Glaucoma initiatives globally," said Thomas Burns, Glaukos chairman and chief executive officer.

Glaukos’s iStent platform involves micro-scale surgical devices designed to reduce intraocular pressure by restoring natural aqueous humor outflow pathways for glaucoma patients. The company plans to begin commercial launch activities for these devices in Europe over the coming months.

According to the company, Glaukos has implanted more than one million iStent devices worldwide since its inception, with its technologies supported by nearly 400 peer-reviewed publications.

The iStent infinite is indicated in the United States for use in adult patients with primary open-angle glaucoma where previous medical and surgical treatment has failed. The device is contraindicated in certain conditions including angle-closure glaucoma where the angle has not been surgically opened.

Glaukos Corporation focuses on developing therapies for glaucoma, corneal disorders, and retinal diseases. The company first developed Micro-Invasive Glaucoma Surgery as an alternative treatment approach, launching its first MIGS device in 2012. While maintaining an impressive gross profit margin of 75.75%, InvestingPro analysis indicates the company is not yet profitable, though analysts expect improved earnings performance in the coming year. For detailed insights and additional metrics, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Glaukos Corporation reported its first-quarter 2025 results, which exceeded Wall Street’s conservative estimates. However, the company’s iDose sales, which reached approximately $21 million, did not meet investor expectations, leading to a revised price target from JPMorgan, now set at $100, down from $160. Analysts at Needham also adjusted their price target to $115 from $176, maintaining a Buy rating, and noted an increase in projected iDose contributions by $5 million. Stephens analysts lowered their price target to $115 from $140 while keeping an Overweight rating, acknowledging challenges in the U.S. glaucoma market despite international sales success. Stifel analysts reiterated their Buy rating with a $115 target, emphasizing a gradual sales ramp for iDose and maintaining high peak sales estimates.

Additionally, Glaukos held its annual stockholders’ meeting, where all proposals, including director elections and the ratification of Ernst & Young LLP as the independent auditor, were approved. The analysts highlighted that reimbursement factors continue to influence iDose sales growth, with a gradual launch curve expected. Investors are closely watching for the U.S. Food and Drug Administration’s decision on iDose re-treatment by the end of 2025, which could significantly impact the stock. Despite the challenges, analysts remain optimistic about Glaukos’ long-term prospects, with expectations of increased iDose adoption as reimbursement expands.

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