InnFocus is working to provide a safe, effective, sustainable and intuitively performed alternative for the surgical treatment of glaucoma. Our lead product—the InnFocus MicroShunt® Glaucoma Drainage System is a glaucoma drainage implant showing promising clinical results.
The company is seeking FDA approval for the InnFocus MicroShunt® as the first minimally invasive stand-alone procedure for mild, moderate, and severe stage open angle glaucoma, which lowers and sustains Intra Ocular Pressure (IOP) under 15 mm Hg, with the potential to eliminate eye drop medications in most patients. Unlike many MIGS (micro-invasive glaucoma surgery) technologies, the InnFocus MicroShunt does not require simultaneous removal of the cataract.
The final phase of the FDA randomized clinical study comparing the InnFocus MicroShunt System to trabeculectomy is underway in 29 centers in the United States and Europe. It is the world's only randomized trial against trabculectomy, the gold standard for lowering IOP.
In clinical trials outside the United States, at 3 years, we are achieving a mean post-operative Intraocular Pressure (IOP) below 15mm Hg, which ophthalmologists believe helps halt the progression of vision loss in glaucoma patients. This represents a reduction of 50% in IOP after 3 years of follow-up. Also, over 60% of the patients have eliminated their use of eye drop medication at 3 years after their procedure. Therefore, the effect appears to be uniquely durable.
Glaucoma/Ocular Hypertension affects over 128 million people worldwide.* The disease is a serious health care problem that is not always easy to diagnose and, often, is difficult to treat. The InnFocus MicroShunt® addresses the largest patient segment in glaucoma.
The Company’s revolutionary SIBS material is ultra-stable, will not degrade and has a 15-year proven history in drug eluting coronary stents. Our scientists have used it to develop our innovative minute ophthalmic device.
In 2016, InnFocus was acquired by Santen Pharmaceutical Co., Ltd., which has contributed its evolving insights to the field of ophthalmology for over a century.
Our team is working hard every day to advance this technology. We invite you to learn more about our company on our website.
President & Chief Executive Officer
*Glaucoma Surgical Device Report, Marketscope® LLC