Glaukos' EU MDR Milestone: Cementing Dominance in the $10B Glaucoma Market

Glaukos Corporation's recent receipt of EU Medical Device Regulation (MDR) certification for its iStent infinite® and iStent inject® W devices marks a pivotal moment for the company's global ambitions. This regulatory win, finalized on June 25, 2025, positions Glaukos as the clear leader in micro-invasive glaucoma surgery (MIGS) and unlocks access to Europe's rapidly growing glaucoma treatment market. With aging populations driving demand and a robust pipeline of next-gen therapies, Glaukos is primed to capitalize on its clinical and commercial dominance—provided it can navigate execution risks and reimbursement hurdles.

Why the EU MDR Certification Matters

The EU MDR framework, one of the strictest medical device regulations globally, requires manufacturers to demonstrate unassailable evidence of safety, efficacy, and quality. Glaukos' certification for its iStent platform—a system designed to reduce intraocular pressure (IOP) via micro-stents—validates its technology in a market where 1 in 20 Europeans over 40 suffer from glaucoma.

CEO Thomas Burns emphasized this milestone as a “strategic foundation” for expanding European operations and accelerating global growth. The certification paves the way for commercial launches in the coming months, directly addressing a $10 billion market where MIGS adoption lags behind the U.S. due to regulatory and reimbursement barriers.

Market Leadership Through Clinical and Commercial Scale

Glaukos' iStent franchise boasts over one million devices implanted worldwide, supported by 400 peer-reviewed studies and 20 years of clinical experience—a scale unmatched by competitors. This data forms a moat against generics and rivals like Aerie Pharmaceuticals or Bausch + Lomb, whose products lack such extensive real-world validation.

The company's first-mover advantage in MIGS has translated into steady revenue growth, with sales rising from $200 million in 2020 to an estimated $450 million in 2024. The EU certification now extends this momentum into a region where 60% of glaucoma patients remain untreated due to cost or accessibility barriers.

Growth Catalysts: Europe and Beyond

Europe's glaucoma market is a goldmine. With an aging population and rising diabetes rates (a key risk factor for glaucoma), the region's demand for minimally invasive, cost-effective therapies like iStent is surging. Glaukos' certification aligns with rising European demand for drop-free glaucoma solutions, which reduce long-term medication costs for healthcare systems.

Meanwhile, Glaukos' pipeline adds further upside. Its iDose TR, a long-acting intracameral pharmaceutical, targets patients resistant to traditional therapies. Combined with its corneal cross-linking treatments, the company is building a full-spectrum portfolio to dominate ophthalmic care.

Analysts project the EU's glaucoma market to grow at 6% CAGR, driven by MIGS adoption and reimbursement reforms. Glaukos' early entry into this space could secure a 25–30% market share by 2030.

Addressing Risks: Adverse Events and Reimbursement

No investment is without risks. Glaukos' iStent infinite faces adverse event concerns, including increased IOP (8.2%) and visual field loss (6.6%) in trials. While these rates are manageable in experienced hands, surgical skill requirements could limit uptake in less specialized clinics.

Reimbursement is another hurdle. Europe's cost-conscious healthcare systems may initially delay iStent's adoption unless Glaukos can prove its long-term cost savings over drugs. The company's clinical trial data, showing sustained efficacy over 12 months, will be critical in securing favorable coverage decisions.

Investment Thesis: Buy the Dip, Hold for the Long Run

Glaukos' EU MDR certification is a buy signal for contrarian investors. While near-term volatility may arise from execution risks, the stock's low valuation (P/E ~15x 2025E earnings) offers a margin of safety. Key catalysts include:
1. Q3 2025 EU launches of iStent infinite/inject, driving revenue growth.
2. iDose TR data readouts in 2026, which could unlock a $3B+ standalone market.
3. Global expansion into Asia and Latin America, leveraging EU credibility.

Bottom Line: Glaukos is the undisputed leader in a $10B market with tailwinds from aging demographics and innovation. While risks exist, the company's scale, data, and pipeline make it a long-term winner. Investors should consider adding shares on dips below $20, with a 12–18 month horizon.

In a sector dominated by incremental improvements, Glaukos' MDR certification isn't just a regulatory win—it's a declaration of intent to own the future of glaucoma care.