Glaukos secures EU approvals for next-gen glaucoma implants

UK—Glaukos Corporation, a California-based medical device company specializing in ophthalmic solutions, has recently achieved significant regulatory milestones in Europe for its micro-invasive glaucoma surgery (MIGS) implants.

The company secured European Union Medical Device Regulation (EU MDR) certification for its iStent platform, including the iStent infinite and iStent inject W devices.

These approvals mark Glaukos’ first clearances under the EU’s new, more stringent regulatory framework designed to ensure the highest standards of quality, safety, and effectiveness for medical devices marketed in the region.

The iStent infinite is a miniature bypass implant that is placed around the edges of the eye to facilitate fluid drainage, thereby reducing intraocular pressure (IOP) in patients with glaucoma.

Similarly, the iStent inject W is designed for implantation during cataract surgery to achieve the same therapeutic goal.

Both devices restore the natural outflow pathways of aqueous humor, which is critical in managing glaucoma and preventing vision loss.

Glaukos CEO Thomas Burns highlighted the importance of these regulatory clearances, stating that they will not only help the company maintain and expand its presence in Europe but also accelerate its broader global initiatives in interventional glaucoma therapies.

The company plans to commence commercial launch activities for these novel MIGS devices in Europe over the coming months, aiming to tap into an estimated US$10 billion European glaucoma market that remains underserved, with about 60% of patients untreated due to cost and accessibility issues.

The company’s iStent technology has a strong clinical foundation, supported by over 20 years of experience, nearly 400 peer-reviewed publications, and more than one million devices implanted worldwide.

Clinical trials have demonstrated that these micro-bypass implants can lower intraocular pressure by 20% or more in approximately 75% of patients after one year, often allowing patients to maintain or reduce their medication regimens.

In the United States, Glaukos received FDA approval for the iStent infinite in 2022, enabling its use as a standalone procedure for patients whose glaucoma was not adequately controlled by prior medical or surgical treatments.

The device consists of three heparin-coated titanium stents, each about one-third of a millimeter in size, preloaded into an autoinjector system that facilitates precise implantation.

Looking ahead, Glaukos is conducting new clinical studies to seek expanded FDA approval that would allow the iStent infinite to be indicated for mild to moderate glaucoma, potentially broadening its patient base further.

Financially, Glaukos is well-positioned to support its growth ambitions.

The company, valued at approximately US$5.67 billion, has experienced nearly 24% revenue growth over the past year and maintains strong liquidity with a current ratio of 6.49, indicating solid financial health as it expands internationally.

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