Glaukos Corporation: EU MDR Certification Ignites a New Era of Global Growth in MIGS

The European Union's Medical Device Regulation (MDR) certification for Glaukos Corporation's iStent infinite® and iStent inject® W devices—secured on June 25, 2025—marks a turning point for the company's ambitions. This milestone not only solidifies its leadership in micro-invasive glaucoma surgery (MIGS) but also opens a $10 billion European market, where aging populations and rising glaucoma prevalence are driving demand. For investors, the certification underscores Glaukos' transition from a niche player to a global leader in interventional glaucoma therapies, with long-term catalysts positioned to fuel growth through 2030 and beyond.

Unlocking Europe: A Market of Untapped Potential

Glaukos' EU MDR approval is a strategic triumph. The certification, which adheres to the EU's stringent new regulatory framework, positions the company to capitalize on a region where 60% of glaucoma patients remain untreated due to cost or accessibility barriers. The iStent platform's track record—over 1 million implants globally, supported by nearly 400 peer-reviewed studies and 20 years of clinical experience—gives Glaukos a critical edge over competitors like Aerie Pharmaceuticals and Bausch + Lomb, whose products lack comparable real-world validation.

By Q3 2025, Glaukos plans to launch its iStent devices commercially in Europe, targeting a market where MIGS adoption lags behind the U.S. due to regulatory and reimbursement hurdles. The company's aim is ambitious: capturing 25–30% of Europe's glaucoma market by 2030, leveraging its scale and data-driven approach to secure favorable reimbursement terms.

Financial Resilience Amid Near-Term Challenges

Glaukos' financial trajectory is compelling. Revenue has surged by nearly 24% over the past four years, climbing from $200 million in 2020 to an estimated $450 million in 2024, driven by strong adoption of its iStent franchise. A current ratio of 6.49 highlights robust liquidity, with liquid assets far exceeding short-term obligations. However, the company remains unprofitable—a red flag for some investors.

Near-term headwinds include softer-than-expected sales of its iDose TR implant, which generated $21 million in Q1 2025 versus analyst expectations. This has led to revised price targets, though the product's long-term potential remains intact. iDose TR, approved in the U.S. in 2023, offers sustained intraocular pressure (IOP) reduction for glaucoma patients, addressing a $3 billion standalone market. Analysts note that reimbursement delays and execution risks in new markets could temporarily weigh on performance.

Pipeline Catalysts: From EU to Global Dominance

The EU MDR certification is just the first step in Glaukos' global play. Key catalysts include:
1. FDA Re-Treatment Approval (2025): While the FDA's February 2025 decision on a PMA supplement for the iStent inject® W focused on design changes, Glaukos is advancing next-generation therapies like the iDose TREX (targeting longer drug release) and its Epioxa corneal crosslinking therapy. The latter, with a PDUFA date of October 2025, could expand its addressable market into keratoconus treatments.
2. Reimbursement Expansion: Glaukos is working with European payers to demonstrate the cost-effectiveness of MIGS over traditional drug therapies. Success here could accelerate adoption in cost-conscious markets.
3. Global Expansion: Beyond Europe, Glaukos aims to penetrate Asia and Latin America, leveraging its EU credibility.

Valuation: A Buying Opportunity in a Discounted Glaucoma Play

Glaukos trades at a 15x 2025E earnings multiple, offering a margin of safety amid its growth trajectory. Analysts project a 6% CAGR for Europe's glaucoma market through 2030, with Glaukos' diversified pipeline—spanning MIGS, pharmaceutical implants, and corneal therapies—positioning it to capture a growing share.

Investors should view dips below $20 as buying opportunities, targeting a 12–18 month horizon. Risks, such as adverse event concerns (8.2% IOP spikes in trials) and reimbursement delays, are manageable given the company's clinical moat and first-mover advantages.

Conclusion: A Long-Term Play on the $10 Billion Glaucoma Market

Glaukos' EU MDR certification is more than a regulatory win—it's a catalyst for sustained growth in one of healthcare's fastest-growing segments. With a pipeline rich in innovation, a fortress balance sheet, and a clear path to European leadership, the company is primed to dominate interventional glaucoma care. While near-term volatility is inevitable, Glaukos remains a compelling buy for investors willing to bet on its long-term vision.

Final recommendation: Buy with a 12–18 month horizon, targeting $30–$35 by 2026.