Sight Sciences, Inc., a venture-backed, commercial-stage ophthalmic medical device company announced today that it has received full IDE approval from the FDA to initiate the world\u2019s first clinical trial comparing ab interno canaloplasty with Selective Laser Trabeculoplasty (SLT). The VISCO\u2122360 versus SLT Glaucoma Trial is a multi-center, prospective, randomized, controlled clinical evaluation that will study the safety and effectiveness of the Sight Sciences VISCO\u2122360 Viscosurgical System in canaloplasty versus SLT in the reduction of intraocular pressure (IOP) in primary open angle glaucoma.<\/p>\n
The VISCO\u2122360 Viscosurgical System* is a fully integrated, single-handed, single-use device that combines a custom access cannula, a soft and flexible microcatheter with an atraumatic tip, an internal infusion pump and viscoelastic reservoir, and a control wheel that advances and retracts the microcatheter.<\/p>\n
Canaloplasty involves the circumferential catheterization and transluminal viscodilation of Schlemm\u2019s canal for the lowering of IOP in patients suffering from glaucoma. The procedure has been around for a decade using an ab externo approach.<\/p>\n
Dr. Steven Sarkisian, Professor of Ophthalmology at the Dean McGee Eye Institute at the University of Oklahoma and a principal investigator in the VISCO\u2122360 Study explained, \u201cI have performed hundreds of ab externo canaloplasties over the years with excellent results. I am excited to participate in the VISCO\u2122360 study to characterize the safety and effectiveness of ab interno canaloplasty for patients with primary open angle glaucoma who do not need a combined procedure with cataract surgery. I believe that glaucoma specialists, comprehensive ophthalmologists, and any anterior segment surgeons will find this familiar ab interno approach to canaloplasty extremely useful for the care of their mild to moderate glaucoma patients and I look forward to participating in this important pivotal study\u201d.<\/p>\n
\u201cWe are extremely excited to begin this pivotal clinical trial investigating the use of our VISCO\u2122360 device for this specific indication. We believe there is a huge unmet need for an effective ab interno glaucoma procedure that is not performed in conjunction with cataract removal and we look forward to working with all of our clinical partners in the execution of this large, robust FDA clinical study,\u201d stated Paul Badawi, Co-Founder and CEO of Sight Sciences.<\/p>\n
Glaucoma is the world\u2019s leading cause of irreversible blindness and affects approximately 80 million people worldwide. Often associated with abnormally high IOP, glaucoma is characterized by progressive vision loss due to irreversible optic nerve damage. It is estimated that 20% of people with glaucoma do have co-existing cataracts while 80% of people with glaucoma do not have co-existing cataracts making a stand-alone surgical option like VISCO\u2122360 an important part of an ophthalmologist\u2019s armamentarium.<\/p>\n