Rayner Completes First Implantations of IOLs in Clinical Trials in China and the US

Rayner has announced the completion of the first implantations in two pivotal market access studies in the US and China.

Rayner's RayOne EMV Toric IOL received investigational device exemption (IDE) approval from the FDA in June. The first study implantation took place at Vance Thompson Vision in Sioux Falls, South Dakota on August 10. The prospective, multicentrer, randomised, masked, active controlled study aims to generate results to support a premarket approval (PMA) submission to the FDA.

"We have had a great experience with the RayOne EMV lens, and as an IDE clinical trial site, I am thrilled to offer this new toric version to my patients and contribute to introducing this remarkable technology to the US market," Dr. Thompson said. 

In April, Rayner received approval from the People's Republic of China's Ministry of Science and Technology (MOST) for a clinical trial involving Rayner's trifocal IOLs. The Human Genetic Resource Administration of China (HGRAC) granted the necessary approval, and the first implantations for this study were carried out in June at The Peking University Hospital by Prof Xuemin Li. The trial, a prospective, multicenter, randomised, parallel-controlled, evaluator-masked, noninferiority clinical trial, aims to evaluate the effectiveness and safety of Rayner's RayOne Trifocal IOL for visual correction of aphakia patients. The completion of this study will facilitate market access for Rayner's RayOne Trifocal technology in China.

"The USA and China hold immense importance for us, and the accomplishments in these clinical trials mark significant progress as we expand our presence in these key markets and provide surgeons and their patients access to our most advanced technology IOLs," said Tim Clover, Rayner CEO.