InnFocus, Inc. (Miami, FL) announced that it received authorization from the FDA to begin the Phase I trial of the InnFocus MicroShunt™ to treat open angle glaucoma and received major financing from HOYA Group.
The trial will be the first to use trabeculectomy with Mitomycin C as a study control. Quoting InnFocus President, Dr. Leonard Pinchuk, “We believe that the excellent clinical results achieved by the InnFocus MicroShunt in earlier clinical evaluations indicate that the device will perform well against the current gold standard of trabeculectomy. An ongoing study, now in its third year in the Dominican Republic, is showing that the InnFocus MicroShunt™ can lower intraocular pressure by 50%-60% with the average pressure residing between 10 and 12 mmHg. This is particularly important in view of many well-documented studies showing that reducing pressure below 14 mmHg arrests progression of the disease. Approximately 90% of our patients are below 14 mmHg and a similar number are totally off of glaucoma medication. The key to our success is our proprietary biomaterial which demonstrates a clinically insignificant foreign body reaction in the eye.”
Concurrently, InnFocus announced a $13.4 million financing led by HOYA and Saints Capital Everest. “HOYA has a well-established global portfolio of ophthalmic product companies. In addition to continuing innovation in intraocular lenses for treatment of cataracts, ophthalmic lenses for vision correction, and contact lenses for lifestyle enhancement, we have chosen an investment in InnFocus to continue our expansion efforts in ophthalmology,” said Taro Hagiwara, Executive Officer, Technology, of HOYA Group.
HOYA Surgical Optics specializes in intraocular lenses with substantial market share in Japan and worldwide. HOYA Vision Care offers the finest quality ophthalmic lenses and the most advanced coating techniques and lens designs available to correct refractive vision problems. Eyecity is a chain of contact lens specialty stores operated by HOYA with about 200 locations in Japan.
“We believe the InnFocus MicroShunt™ shows great promise to change the treatment of glaucoma. We are pleased to have the opportunity to invest in this compelling new technology and take part in bringing wellness to patients suffering from this disease,” said Thomas A. Dunlap, President and CEO of HOYA Surgical Optics.
Scott Halsted of Saints Capital said: “The Series B financing ensures that the Company will have adequate funds to complete the Phase I IDE, to begin Phase II enrollment and to clear the way for sales and marketing in Europe where the Company has received CE Mark.” Dr. Pinchuk added, “We are very excited that HOYA chose to invest in our technology and Company.”
About HOYA Group: Since its establishment in 1941 as a specialty manufacturer of optical glass, HOYA has diversified into new business areas that exploit the potential of advanced optics technologies including implantable intraocular lenses. The Group has continued to grow as a global enterprise through the expansion of its diverse business activities, which encompass Information Technologies, Eye care, Medical, and Imaging.
About InnFocus, Inc.: InnFocus, Inc. is a privately-held company headquartered in Miami, Florida. Company scientists and engineers are global leaders in the development of highly biocompatible biomaterials and medical devices. The InnFocus MicroShunt™ is the first of what the Company expects to be many medical devices incorporating these materials in the eye. The InnFocus MicroShunt™ was developed in collaboration with the University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute.