Staar Surgical Co expects a delay in approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its Visian Toric ICL, its implantable lens to treat myopia and astigmatism. The PMDA has, however, not sought any more clinical trials for Visian Toric ICL. The company’s Visian ICL products are, however, on a “very quick path” to approval in the country. Visian ICL (Implantable Collamer Lens) is used to treat myopia or nearsightedness.

An intraocular lens can correct myopia within 0.5 D of the target in 79% of eyes and caused no vision-threatening complications. This was reported by Japanese investigators from the University of Kitasato in the July issue of Archives of Ophthalmology. “Our long-term results indicate that [implantable collamer lens (ICL)] implantation is safe and effective and provides predictable and stable refractive results in the correction of moderate to high myopia throughout a four-year observation,” the authors said. These findings suggest that ICL implantation may be a good alternative for the treatment of moderate to high myopia.

STAAR Surgical Company has received approval from the Sate Food and Drug Administration (SFDA) of the People’s Republic of China to market its Visian™ Toric Implantable Collamer Lens (ICL) in the country for treating nearsightedness and astigmatism. This lens, made of a highly biocompatible material called Collamer, is minimally invasive and foldable. The ICL procedure makes an incision that is as much as 50% smaller than that made by other technologies and the lens is placed behind the iris.