bioaccess.™ Helps ClarVista Medical (acquired by Alcon) Gain Approval in Colombia to Commercialize its HARMONI® Modular IOL – a Novel IOL Used to Restore Vision after Cataract Surgery
[ORLANDO, FL, FEBRUARY 21, 2018] - ClarVista Medical, Inc. ("ClarVista"), a privately-held ophthalmic device company —acquired by Alcon in 2017— developer of the HARMONI® Modular IOL System, a novel intraocular lens (IOL) used to restore vision after cataract surgery, obtained regulatory approval at Colombia's INVIMA to commercialize its HARMONI® Modular IOL. bioaccess.™led the registration process and became ClarVista's regulatory legal representative in Colombia.
According to the National Eye Institute, cataract disease is one of the leading causes of vision loss and blindness globally with an estimated 150 million people worldwide who suffer from impaired visual acuity due to a cataract in one or both eyes. A cataract is the clouding of the natural lens of the eye, and if left untreated, can lead to blindness. Fortunately, vision can be restored through cataract surgery, a procedure in which the patient’s opaque natural lens is removed and replaced with an artificial intraocular lens (IOL).
The HARMONI® Modular IOL features a base component that acts as a stable platform to receive vision-correcting optics. Optics ranging from monofocal and toric lenses to advanced multifocal and enhanced depth of focus technology can be used to give patients the best chance of reaching their personalized visual needs. Additionally, the modular design gives physicians the confidence to customize outcomes for each individual patient.
ClarVista was established with intellectual property licensed from the University of Colorado’s technology transfer office, CU Innovations. The intellectual property covers technology invented by Malik Kahook, MD and Naresh Mandava, MD, faculty at CU's the Department of Ophthalmology. The Alcon acquisition of ClarVista follows a period of collaboration between the two companies to develop a modular intraocular lens platform for implantation after cataract surgery.
On February 16, 2018, Colombia's regulatory agency —INVIMA— issued a registration certificate number 2018006325 which enables ClarVista to import and sell its HARMONI® Modular IOL System in the national territory.
About ClarVista Medical
ClarVista Medical, Inc. (acquired by Alcon in 2017), is a clinical and commercial stage ophthalmic device company focused on the development of the HARMONI® Modular IOL System. ClarVista is developing a full range of intraocular lenses to address significant unmet needs in the IOL market.
Julio G. Martinez-Clark, +1 (954) 903-7210
Chief Executive Officer