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Ivantis cleared to begin trial of Hydrus in advanced glaucoma

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The FDA has cleared Ivantis to begin a second investigational device exemption clinical trial for its Hydrus microstent, according to a company press release.

The clearance will allow the company to study the microstent in patients with advanced glaucoma who are undergoing standalone glaucoma surgery without combined cataract surgery.

The SUMMIT trial will assess the 12-month safety and effectiveness of the Hydrus in 60 patients.

“As we move into the more advanced glaucoma cases, we often need to sacrifice safety to achieve the necessary efficacy required to lower intraocular pressure,” OSN Glaucoma Section Editor Thomas W. Samuelson, MD, medical monitor for the SUMMIT trial, said in the release. “The fact that Hydrus has the potential to be used on both ends of the glaucoma spectrum is an important differentiator since, from a labeling standpoint, no MIGS device has yet demonstrated the safety and efficacy to be considered for such broad use.”

The Hydrus is already being studied in patients with mild to moderate glaucoma who are undergoing cataract surgery, and the company anticipates FDA approval for that indication in 2018, the release said.