Ivantis Announces Settlement of Glaukos Patent Litigation

IRVINE, Calif., Sept. 15, 2021 /PRNewswire/ -- Ivantis, Inc., developer of the novel Hydrus^® Microstent, a minimally invasive glaucoma surgery (MIGS) device designed to lower eye pressure for open-angle glaucoma patients, today announced that it has entered into an agreement with Glaukos Corporation to settle and dismiss all pending global litigation between them. Under the agreement's terms, Ivantis has agreed to pay a total of US$60,000,000 in two installments before the end of 2022, and a 10% royalty on Hydrus Microstents sold or made in or imported into the United States through April 26, 2025. The parties have also agreed to a mutual limited, non-exclusive cross-license and covenant not to sue each other's existing or closely related products on their existing or related future patents.

"Although we have always believed our pioneering technology does not infringe any valid claim of any of Glaukos' patents, we are pleased to put this distraction behind us. Given the upward trajectory of our business and the rapidly increasing adoption of Hydrus in the market, we are fortunate to be in a position to be able to readily absorb this settlement as we continue bringing our best-in-class MIGS technology to our customers and their patients," said Dave Van Meter, president and CEO of Ivantis. 

About Hydrus Microstent
Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm's canal, the eye's natural outflow pathway. When placed in the canal during minimally invasive microsurgery, the device restores the flow of fluid in the eye, using a Tri-Modal^® mechanism of action:

1. The Hydrus Microstent dilates and scaffolds Schlemm's canal to augment outflow of aqueous humor from the anterior chamber.
2. It maintains an opening through the trabecular meshwork from the anterior chamber into Schlemm's canal.
3. Its length spans approximately 90 degrees of the canal to provide consistent access to multiple fluid collector channels in the eye.

Approved by the FDA in August 2018 for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG), the Hydrus Microstent is the most rigorously researched and thoroughly studied MIGS devices, with more than 4,000 cases treated globally in controlled clinical studies and registries in patients with a wide range of disease severities, with some patients followed beyond five years after surgery.

Ivantis' patented Hydrus Microstent recently received the highest combined grades for Level of Evidence, Quality of Supporting Body of Evidence and Recommendation for Care of any MIGS device reviewed by the American Academy of Ophthalmology in its 2020 Preferred Practice Pattern^® treatment guidelines (PPP)¹.

The Hydrus Microstent is supported by the largest MIGS pivotal trial to date and the only pivotal study continuously following patient outcomes out to five years.  Study results show:   

• Demonstrated long term benefit in keeping patients off glaucoma medications; 66% of Hydrus Microstent patients remained glaucoma medication-free at five years.
• Over 60% reduction in risk of invasive secondary glaucoma surgeries (e.g., tube shunts and trabeculectomy) compared to cataract surgery alone.
• These clinical benefits were observed without an increased safety risk.

About Ivantis

Ivantis, Inc. is a privately held company established in 2007 to design, develop and commercialize new technologies to treat eye disease. Investors include New Enterprise Associates, Delphi Ventures, Foresite Capital, RA Capital Management, Ascension Ventures, EDBI, GBS Ventures, MemorialCare Innovation Fund, Merieux Development and Vertex Healthcare. The company is headquartered in Irvine, California.

Ivantis^®, Hydrus^® and Tri-Modal^® are registered trademarks of Ivantis, Inc. All rights reserved 2021.

References

1. Gedde SJ, Vinod K, Wright MM, Muir KW, Lind JT, Chen PP, Li T, Mansberger SL, on behalf of the American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Primary Open-Angle Glaucoma Preferred Practice Pattern^®. Ophthalmology. 2020. doi:10.1016/j.ophtha.2020.10.022

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