Glaukos Corp (GKOS): A High-Growth Play in Interventional Glaucoma Amid Regulatory and Market Headwinds

In the rapidly evolving landscape of ophthalmic innovation, Glaukos Corporation (GKOS) stands at the intersection of medical technology and pharmaceuticals, pioneering solutions for chronic eye diseases. While the company faces near-term challenges, including reimbursement uncertainties and competitive pressures, its robust product pipeline, accelerating market adoption of interventional therapies, and strategic positioning in a $9-billion global glaucoma treatment market position it as a compelling long-term investment.

Product Pipeline: Innovation as a Growth Engine

Glaukos's iDose® TR (travoprost intracameral implant) is the cornerstone of its current success. This FDA-approved, first-of-its-kind sustained-release implant delivers glaucoma medication continuously for up to three years, reducing intraocular pressure (IOP) by 44% at six months in a pivotal trial. The 36-month follow-up data—showing sustained efficacy and safety—underscore its potential to redefine glaucoma management. With 70% of patients remaining well-controlled on fewer medications at three years, iDose TR aligns with the industry's shift toward reducing medication burden, a critical unmet need in a market where patient adherence to eye drops is notoriously poor.

The company's iDose TREX, a next-generation platform with nearly double the drug capacity of iDose TR, is now in Phase 2b/3 trials. This advancement could extend therapeutic duration, further differentiating Glaukos in a crowded procedural pharmaceutical space. Additionally, iDose Trio, a multi-drug implant targeting multiple glaucoma mechanisms, is slated for clinical trials by 2027, offering a long-term roadmap for innovation.

Glaukos's commitment to R&D is evident: it reinvests ~30% of sales into innovation, ensuring a steady flow of novel therapies. Its PRESERFLO MicroShunt and Epioxa corneal cross-linking therapy (with a PDUFA date in October 2025) further diversify its portfolio, targeting both glaucoma and keratoconus.

Market Adoption: Momentum in a Shifting Paradigm

The iDose TR has achieved rapid market traction, contributing $31 million in Q2 2025 revenue and driving 30% year-over-year net sales growth. This success is fueled by expanding Medicare coverage across key MACs (Noridian, Novitas, First Coast) and growing surgeon adoption. Glaukos's U.S. glaucoma sales surged 41% YoY in Q1 2025, with iDose TR generating an $85 million annualized run rate.

Physician feedback highlights the implant's ease of use during cataract surgery and its role in reducing postoperative IOP fluctuations. Meanwhile, the iStent Infinite—cleared under EU MDR for all stages of open-angle glaucoma—has broadened Glaukos's commercial footprint in Europe, a key growth market.

However, challenges persist. Reimbursement headwinds, particularly for legacy MIGS devices like the iStent inject, have pressured non-iDose revenues, which are projected to decline mid-single digits in 2025. Additionally, the acquisition of Mobius Therapeutics introduces supply chain risks, though it also provides access to corneal cross-linking technology.

Strategic Positioning: Leading the Interventional Glaucoma Revolution

The interventional glaucoma (IG) market is projected to grow at 2.86% CAGR through 2034, driven by MIGS adoption and laser therapies. Glaukos is uniquely positioned to capitalize on this growth. Its iDose TR and iStent Infinite align with the Interventional Glaucoma Working Group's consensus protocol, which prioritizes early intervention and procedural therapies over traditional drops. This protocol categorizes patients into four disease groups, with iDose TR and MIGS devices serving as first-line options for ocular hypertension and mild-to-moderate glaucoma.

Competitive pressures are mounting, with Alcon's Hydrus Microstent and Sight Sciences' OMNI Surgical System vying for market share. However, Glaukos's dual-growth engine—combining MIGS and procedural pharmaceuticals—creates a moat. The company's focus on dropless, long-term IOP control resonates with both patients and physicians, particularly as healthcare systems prioritize cost-effective solutions.

Challenges and Opportunities

While Glaukos's long-term prospects are strong, near-term risks include:
1. Reimbursement Uncertainty: Payer coverage for MIGS and procedural pharmaceuticals remains inconsistent, potentially slowing adoption.
2. Market Saturation: The MIGS segment is becoming crowded, requiring Glaukos to differentiate through clinical evidence and surgeon education.
3. Regulatory Risks: The PDUFA date for Epioxa (October 2025) and the approval timeline for iDose TREX are critical milestones.

Yet, these challenges are balanced by opportunities. The aging global population and rising prevalence of glaucoma (projected to affect 111 million people by 2040) create a growing demand for innovative treatments. Glaukos's pipeline, with multiple products in development, offers a diversified approach to capturing this demand.

Investment Thesis: A Buy for the Patient, High-Conviction Investor

For investors with a 3–5 year horizon, Glaukos presents a high-conviction opportunity. Its iDose TR has already demonstrated market leadership, while its next-gen pipeline and strategic expansion into procedural pharmaceuticals and MIGS position it to dominate the evolving glaucoma treatment paradigm.

Despite near-term headwinds, Glaukos's ability to navigate regulatory hurdles, secure broader reimbursement, and scale its commercial infrastructure will determine its long-term success. The company's focus on reducing medication burden and improving patient outcomes aligns with broader healthcare trends, making it a compelling play in a market poised for sustained growth.

Final Verdict: Glaukos Corp is a high-growth stock with strong fundamentals. While volatility is expected due to regulatory and reimbursement risks, its innovative pipeline and leadership in interventional glaucoma make it a buy for investors seeking exposure to a transformative sector.