Glaukos Completes Enrollment in Pivotal U.S. Study for PRESERFLO MicroShunt
GKOS has more than doubled off its 52-week low of $73.16 on light trading volume (0.4× avg).
Summary
Glaukos has completed patient enrollment in its U.S. 510(k) pivotal study for the PRESERFLO MicroShunt, a minimally invasive glaucoma drainage device targeting patients with advanced glaucoma who have failed prior surgeries. The trial enrolled at least 110 patients across the U.S. and Canada, with the primary endpoint being a 20% or greater reduction in intraocular pressure at 12 months. This milestone advances the device toward a potential FDA submission, expanding Glaukos' glaucoma portfolio beyond its existing MIGS and iDose TR products. The device is already approved in Canada and Australia, providing real-world evidence that may support U.S. regulatory review. With the stock trading near its 52-week high and strong Q1 revenue growth of 41% year-over-year, this progress reinforces the company's pipeline momentum. Next catalyst: 12-month data readout, which will determine the filing timeline.
At the time of this announcement, GKOS was trading at $153.59 on NYSE in the Life Sciences sector, with a market capitalization of approximately $9B. The 52-week trading range was $73.16 to $161.53. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.