Glaukos (GKOS) investor relations material

LCD proposal and regulatory environment

• Draft LCD surprised management, especially the requirement for both failed drops and failed SLT before iDose eligibility, which could exclude many patients.

• Company plans to educate MACs during the open comment period, highlighting patient cohorts ineligible for drops or SLT and advocating for changes.

• Concerns raised about the two-year re-administration requirement, which differs from the FDA label and clinical studies; efforts underway to align policy with clinical evidence.

• Ophthalmology societies and physicians are supportive and will participate in the comment process.

• Open meetings with MACs and public comment periods are scheduled over the next month, with comment letters expected to become public.

Market dynamics and patient eligibility

• About one-third of patients in a high-volume surgeon's data were not eligible for SLT, and 650,000 SLTs are performed annually.

• SLT failure rates are high: 50% fail after two years, 75% after five years, making many patients eligible for iDose.

• Treatment paradigms vary by surgeon, with SLT as a common first-line intervention, but not universally adopted.

• Optimal LCD outcome would allow iDose for patients ineligible for either drops or SLT, and align re-implantation intervals with FDA labeling.

• Ongoing phase IV trials on iDose in combination with MIGS and cataract surgery, with data expected next year.

Business impact and growth outlook

• If LCD is finalized as proposed, strategy would shift to focus on patients who have failed SLT, but the long-term market opportunity remains large.

• There are 6 million patients with prior SLT and 12 million eyes diagnosed and treated for glaucoma, most on drops.

• Recent strong first quarter results for iDose, with expanding coverage from MACs and Medicare Advantage.

• Medicare Advantage coverage is robust and will be further solidified by the LCD, clarifying policies and filling gaps.