Staar's Collamer accommodating study team reports first phase

October 28, 2009

STAAR Surgical Company has reported that the Collamer Accommodating Study Team (CAST) formed by the company in late 2008 has provided very promising initial patient vision assessments from the first phase of the project.

STAAR Surgical Company has reported that the Collamer Accommodating Study Team (CAST) formed by the company in late 2008 has provided very promising initial patient vision assessments from the first phase of the project.

The CAST is comprised of eight prominent cataract/refractive surgeons from across the United States who since June 2009 have implanted more than 300 eyes with the STAAR nanoFLEX intraocular lens (IOL) for the treatment of cataracts. The purpose of the CAST first phase is to evaluate the accommodating properties of the current nanoFLEX IOL to establish a baseline for future phases.

Of the more than 300 eyes implanted, up to four months of follow up has been assessed on 73 binocular near vision patients (146 eyes) and 59 binocular intermediate vision patients (118 eyes). Based on the preliminary assessment, the outcomes indicate that nanoFLEX provides superior distance-corrected near vision compared with the leading standard IOLs and comparable results to current premium IOLs. In addition, the outcomes indicate that nanoFLEX provides superior distance-corrected intermediate vision to any IOL compared - including premium IOLs. The collective data from the CAST was presented during the American Academy of Ophthalmology (AAO) by Dr. James Lewis from Philadelphia, Pennsylvania. Craig Felberg, Vice President of Research and Development, STAAR Surgical, presented longer term patient data on the accommodative properties of the Collamer material which was collected by Dr. Liviu Saimovici of New York City. Mr. Felberg also reviewed the plans for the CAST Second Phase.

“The CAST assessment of the baseline accommodating properties of the new Collamer nanoFLEX IOL is quite encouraging and better than we expected when this evaluation began,” said Barry G. Caldwell, President and CEO of STAAR Surgical. “Our product development team is engineering minor design changes to the nanoFLEX for the purpose of a Second Phase which will include a clinical study by CAST members to determine whether these minor design changes can improve upon current results.”

“In my practice the nanoFLEX IOL has clearly demonstrated the excellent near vision results found by the CAST when compared to both standard and premium IOLs in the market,” said Dr. James S. Lewis, CAST member. “It seems quite likely that with design enhancements the accommodative properties of the nanoFLEX can be expanded to compete very effectively in the premium IOL segment.” “Longer term patient data on a Collamer IOL provided by Dr. Liviu Saimovici showed superior distance-corrected near vision results when compared to all premium IOLs including the accommodating and multifocal IOLs in his analysis,” said Mr. Felberg. “For the balance of 2009, the CAST will continue the current follow up activity on all patient eyes implanted. Within six months we hope to have preliminary data for the Second Phase which will compare the accommodating performance of the existing nanoFLEX versus the redesigned nanoFLEX.”