Rayner Appoints Ophthalmic Leaders as Strategic Advisors and is Awarded IDE for Trifocal IOLs
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 the recent acquisition of Omidria from Omeros Corporation, Rayner also announce that the FDA has approved their request to conduct a clinical study on their premium RayOne Trifocal and RayOne Trifocal Toric IOLs. This Investigational Device Exemption (IDE) approval enables Rayner to move forward with a prospective, multicenter, randomised, masked and active controlled study. If successful, the results of the study are intended to allow a premarket approval (PMA) submission to the FDA.
“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,” Rayner’s CEO Tim Clover said in a company news release. “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. 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.”