Rayner has announced the appointment of Eric Donnenfeld, MD; Kerry Solomon, MD; Vance Thompson, MD; and Jim Mazzo as strategic advisors to the business, with a specific focus on supporting the expansion of Rayner’s presence in the US.
Following on from the recent acquisition of Omidria™ from Omeros Corporation, Rayner is proud to also announce that the U.S. Food and Drug Administration (FDA) has approved their request to conduct a clinical study on their premium RayOne Trifocal and RayOne Trifocal Toric intraocular lenses (IOLs).
This Investigational Device Exemption (IDE) approval enables Rayner to move forward with a prospective, multicentre, randomised, masked and active controlled study. If successful, the results of the study are intended to allow a Pre-Market Approval (PMA) submission to the FDA.
Rayner’s CEO, Tim Clover, commented on this news, “Driving significant growth in the US is one of our strategic corporate objectives and the IDE not only shows our commitment to North America but also the exciting opportunities that lie ahead for our customers. With the support of our newly appointed advisors, we look forward to bringing more of our Rayner portfolio to the US market.”
On his appointment as a strategic advisor and news of IDE approval, Dr Vance Thompson commented, “The European clinical results for RayOne Trifocal are excellent and as an IDE clinical trial site, I am excited to offer this solution to my patients who desire complete spectacle independence. I have long admired Rayner’s pioneering approach to lens technology as well as its commercial agility, and I look forward to joining a small group of respected peers to support their growth journey over the coming years.”
About RayOne Trifocal
RayOne Trifocal is the newest member of the RayOne family of preloaded IOLs, based on anti-vaulting haptic technology, which provides rotational and centrational stability, plus excellent fixation in the capsular bag.
RayOne Trifocal has fewer rings on the optic surface than many trifocal IOLs for reduced potential visual disturbances and improved night vision. It has a new patented diffractive profile that has been designed in partnership with a leading European technology institute.
About RayOne Trifocal Toric IOL
RayOne Trifocal Toric utilises Rayner’s patented diffractive profile that was designed in partnership with a leading European technology institute.
RayOne Trifocal Toric lens is made from biocompatible hydrophilic acrylic material with a long safety record, based on proven haptic technology for excellent stability. Its aberration-neutral aspheric optic provides visual quality and acuity in all light conditions, with zero glistenings.