The InnFocus Story
InnFocus is an ophthalmology company founded in 2004 with extensive biomaterials experience that develops and provides next generation products for glaucoma surgery. Glaucoma is a disease for which there is no cure, is the second leading cause of blindness in the world.
The Company's scientists and engineers are global leaders in the development of highly biocompatible biomaterials and medical devices. The InnFocus MicroShunt® Glaucoma Drainage System (formerly known as the "MIDI Arrow") is the first of what the Company expects to be many medical devices that incorporate these materials in the eye. It was developed in collaboration with the University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute.
The InnFocus MicroShunt® is a glaucoma drainage implant consisting of a micro-tube about twice the size of an eyelash. It is made from a proprietary biomaterial that demonstrates insignificant inflammation of encapsulation in the eye. It is implanted with the inflow end in the anterior chamber at the angle and the outflow end under the conjunctiva and Tenon's capsule. The mechanism of action for subconjunctival drainage for the device has been accepted as the gold standard for several decades.
In clinical trials outside the United States, at 3 years, treated patients 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.
The InnFocus MicroShunt® acquired CE Mark approval from the National Ministries of Health in 2012 which is mandatory for marketing and selling products in the European markets. The final phase of the FDA randomized clinical study comparing the InnFocus MicroShunt® to trabeculectomy is underway in 29 centers in the United States and Europe. It is the world's only randomized trial against trabeculectomy, the gold standard for lowering IOP.
In 2016, InnFocus was purchased by Santen Pharmaceutical Co., Ltd., a Japanese pharmaceutical company, specializing in ophthalmology and rheumatology medicines. With its ophthalmic products Santen holds the top share within the Japanese market and is one of the leading ophthalmic companies worldwide, with its products being sold in over 50 countries.