Three years after Alcon pulled its CyPass Micro-Stent from the market due to safety concerns, the Novartis spinoff has found another glaucoma treatment device to take its place.
The Hydrus Microstent will join the ophthalmologic device portfolio through Alcon’s acquisition of Ivantis, the developer and manufacturer of the stent. Alcon will pay $475 million upfront for the California-based company, with the possibility of additional payments as it hits predetermined regulatory and commercial milestones.
“Glaucoma is the second-largest cause of blindness after cataracts, impacting more than 75 million people globally, with significant unmet patient need. This transaction will allow us to add a uniquely effective product into our glaucoma portfolio around the world,” said Alcon CEO David Endicott. “Our global commercial footprint and development capabilities make us well positioned to build on the success of Ivantis and help even more patients see brilliantly with Hydrus Microstent.”
The buyout is expected to close in the first quarter of 2022.
The Hydrus device, which is about the size of an eyelash, is implanted in Schlemm’s canal in a minimally invasive surgical procedure. Once placed, it expands the canal, allowing for easier drainage of fluid from the eye to the circulatory system to reduce pressure on the eye, a common symptom of glaucoma.
Ivantis’ microstent was approved by the FDA in August 2018. It’s indicated in the U.S. for placement during cataract surgeries for patients with mild to moderate primary open-angle glaucoma. The device has also been cleared in the U.K., Canada, Australia, Singapore and Germany, where it can be implanted either in conjunction with a cataract surgery or in a standalone procedure.
Since then, more than 85,000 glaucoma patients have been implanted with the Hydrus device, Dave Van Meter, president and CEO of Ivantis, said in a statement.
In a five-year study of the Hydrus Microstent, patients who received the device experienced a 60% reduction in the need for secondary invasive glaucoma surgeries. Additionally, nearly two-thirds of patients remained medication-free five years after the implant procedure.
The FDA’s approval for the Hydrus device came the same month Alcon began a voluntary recall of all versions of its own CyPass Micro-Stent.
Though Alcon’s glaucoma-treating stent had been approved by the FDA in 2016—backed by the results of a two-year clinical trial—post-surgery data collected in a five-year safety study showed that, over time, patients implanted with the CyPass device experienced significantly more endothelial cell loss than those who underwent only standard cataract surgery.
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