Rayner announced the US Food and Drug Administration (FDA) approval and US commercial availability of RayOne Galaxy and RayOne Galaxy Toric, which the company describes in a press release as the world’s first spiral intraocular lens (IOL) platform. Developed with artificial intelligence, Galaxy features a spiral design engineered to reduce halo and glare. Galaxy's nondiffractive spiral optic delivers a smooth and continuous full range of vision with minimized dysphotopsia and 0% loss of transmitted light.1
The FDA approval follows an Investigational Device Exemption (IDE) study involving more than 250 patients across 10 US sites. According to the company, results showed a strong safety profile, with patient-reported outcomes demonstrating low levels of bothersome dysphotopsia. The launch follows the company's recent FDA clearances for RayOne EMV Toric and the Sophi Phacoemulsification System.
Reference
1. Abela-Formanek C, Amon M, Auffarth GU, et al. Performance of the first spiral refractive intraocular lens for continuous full range of vision. J Refract Surg. 2025;41(11):e1213-e1222. doi:10.3928/1081597X-20250829-01