for Immediate Release
Contact: Claire R. Wynters, Public Relations
(June 14, 2007 – Saratoga Springs, NY) Rayner Intraocular Lenses Ltd. of Great Britain has proudly announced that it is the first Intraocular Lens manufacturer based outside the United States to receive FDA PMA approval for an IOL product in over 20 years. Their C-flex™ injectable acrylic lenses had already been approved and in use in Europe and throughout the rest of the world.
Criterium, Inc. provided Project Management, Data Management and Statistical support for Rayner’s clinical trials on this device leading to FDA approval.
“The clinical trial was well organized and executed. Criterium and their people formed a capable, competent and efficient partner in this process,” commented Mark Mullaney, Regulatory Affairs & Quality Assurance Director for Rayner “Any queries from the investigational sites, the monitors and/or the FDA were responded quickly and to everybody’s satisfaction.”
In this clinical study Criterium remotely managed sites in the United States, Austria and Germany. Using real-time processes, Criterium standardized the data management across national borders for multiple studies, and supported multiple submissions and supplements to the FDA until its eventual approval within months of the final 3 year evaluation.
The Centerflex™/ C-flex™ study program was initiated with the first patient enrolled in December 2000 and a total of 483 patients were enrolled through the end of 2004. Over the course of each study, data was managed through Criterium’s proprietary trial management software (StudyControl ™), where real-time data gathering and analysis processes provides continuous information, metrics and reports about site performance.
“We are extremely pleased that the technology applications we developed for these studies on behalf of Rayner had such a positive response from the FDA,” said John M. Hudak, President and Founder of Criterium, Inc. “Criterium enhanced these tools over the course of the study while staying true to our goal to deliver every project, to every client, done correctly and on time. The real-time capabilities of our processes were essential: Criterium’s remote site management and daily review of data led to a reduced number of monitor visits to sites, because each visit was more productive. The most important outcome is regulatory approval of the data that we collected and submitted on behalf of our client. This once again validates our systems, processes and agile workflow.”
Rayner is a leader in the global ophthalmic surgery market. It is the only British manufacturer of intraocular lenses (IOLs) - implant lenses for ophthalmic surgery. Rayner started IOL manufacture in the 1940s. The first IOL implanted by Sir Harold Ridley on November 29, 1949 in St Thomas’s Hospital London was a Rayner lens. Manufacture of IOLs has continued uninterrupted since 1949. For over fifty-eight years Rayner has been at the forefront of IOL design and research - working with all the IOL pioneer surgeons and world-famous university and clinical research establishments. In 1981 Rayner IOLs were the first IOLs to be approved as safe and effective by the US Food and Drug Administration (FDA).
C-flex™ injectable acrylic lenses have Rayner’s well-established AVH Technology™ plus the unique Enhanced Square Edge for reducing the risk of secondary cataract. The bio-compatible Rayacryl™ material has an unmatched track record on low affinity for silicone oil, sustained clarity and an absence of glare and unwanted imagery. The patented Anti-Vaulting Haptics provide excellent centration, no rotation and no vaulting. This largely contributes to accurate visual outcomes. The system is more than just the lens. It is also a “first” in that the lens is uniquely packaged with an FDA-approved single-piece, single-use injector. Please visit www.rayner.com for more information.