Ivantis said today it won approval from the FDA to initiate a 2nd investigational device exemption trial of its Hydrus microstent, testing the device in patients with advanced glaucoma who are undergoing stand-alone glaucoma surgery without combined cataract surgery.
The Hydrus microstent is designed for minimally invasive microsurgical procedures to reduce eye pressure in patients with glaucoma. The device is multi-modal, the company said, by creating a large opening through the trabecular meshwork and dilating and scaffolding the conventional pathway through which fluid exits the eye.
In the newly approved Summit trial, Ivantis will explore the use of the Hydrus microstent in more advanced glaucoma cases, with hopes of showing that the device exhibits the safety and efficacy required for later-stage approaches.
“Thanks to the advent of minimally invasive glaucoma surgery, we now have several tools in our armamentarium to treat this disease effectively. However, 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. 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,” trial medical monitor Dr. Thomas Samuelson said in a prepared statement.
The trial will analyze the safety and effectiveness of the device at 12 months in 60 advanced glaucoma patients who have had no success with conventional therapies, the company said.
“As clinicians, we are constantly seeking to delay the traditional, most invasive glaucoma procedures in challenging patients, as late-stage glaucoma procedures tend to have a complication profile that is often undesirable. I’ve been able to evaluate the Hydrus over the past four years in an open-label registry, and am impressed with the device’s versatility. The device offers me an option for my more advanced glaucoma patients that I have found to be both safe and effective. Most importantly, my patients who have received the Hydrus have been highly satisfied with their outcomes,” Dr. Leon Au of the UK’s Manchester Royal Eye Hospital said in a press release.
“With the addition of this second trial, the Hydrus Microstent will have been evaluated in a full range of mild to advanced glaucoma, representative of the approximately 5 million US patients with glaucoma. We have followed thousands of patients through trials and registries, and our belief is that no other MIGS device provides the versatility, utility and combined safety and efficacy profile as the Hydrus Microstent in treating such a wide array of glaucoma, offering hope to both the patients debilitated by this blinding disease and the practitioners who care for them,” CEO & prez Dave Van Meter said in a press release.
In January, Ivantis said it raised $25 million in a Series C round of financing to support its Hydrus microstent. The round was led by newly invested RA Capital Management and joined by new investor Mérieux Développement and existing investors.