iSpheric gains US approval
The iSpheric Model YA-60BB intraocular lens (IOL) (Hoya) has received FDA approval.
The iSpheric Model YA-60BB intraocular lens (IOL) (Hoya) has received FDA approval.
The foldable hydrophobic IOL, which is already available in Europe and Asia, features a blue-light blocker and can be implanted through an un-enlarged incision. In a clinical trial, 98% of the 600 enrolled subjects reported best corrected visual acuity (BCVA) of ≥20/40 from one-month postoperatively until the final 12-month follow-up visit. No significant adverse events were reported.
The iSpheric will have its official launch at this year's American Academy of Ophthalmology (AAO) meeting, which will be held November 8–11 in Atlanta, GA, US. The lens will be shipped to facilities in the US by the end of the year, and a new version, available in the iSert pre-loaded injector system, will be available in early 2009.
