Patient enrolment concludes in Glaukos’ Preserflo MicroShunt trial
Glaukos said patient enrolment is complete for its US 510(k) pivotal, prospective multi-centre single-arm trial of the Preserflo MicroShunt in adults with primary open-angle glaucoma. The study reached at least 110 patients. The main endpoint is a 20%+ reduction in mean diurnal IOP at 12 months without adding medication classes. Glaukos plans FDA marketing clearance using trial data.
How this was made
The 30-second read
Why it matters
Reaching the enrolment target (at least 110 patients) is a procedural de-risking step and supports the company’s plan to submit trial data to the FDA for marketing clearance, but the market will likely wait for the 12-month primary endpoint results.
Market read
Operational completion of enrolment in a pivotal US trial can improve confidence in the regulatory path, but it is not yet an efficacy or clearance event.
What to watch
Key near-term risk is whether the 12-month endpoint meets the 20% mean diurnal IOP reduction target without increasing medication classes; the article provides no interim efficacy or safety data.
Background
Glaukos is running a US 510(k) pivotal, prospective, multi-centre, single-arm trial of the Preserflo MicroShunt in adults with primary open-angle glaucoma not adequately controlled after prior treatments.
Market effects
Adds incremental momentum for glaucoma device development and the broader ophthalmic medtech pipeline narrative.
US and Canada trial progress may influence expectations for North American regulatory and commercialization timelines.
Because the device is already approved in some markets, US trial progress can shift global expectations for expansion into the US.
Counterpoint
Enrollment completion may not move the stock much if investors are focused on the 12-month primary endpoint and FDA review risk rather than execution milestones.
Key entities
- companyGlaukos
Sponsor of the US 510(k) pivotal Preserflo MicroShunt trial; plans to use trial data for FDA marketing clearance.
- medical_devicePreserflo MicroShunt
Ab-externo, minimally invasive glaucoma drainage device using an 8.5mm flexible SIBS design.
- partnerSanten Pharmaceutical
Holds a licensing agreement granting Glaukos exclusive development and commercialization rights in multiple regions including the US.
- regulatorUS Food and Drug Administration (FDA)
Agency Glaukos intends to seek marketing clearance from using the trial data.
