Staar Gets U.S. Approval for Ophthalmic System

0

Staar Surgical Co.’s share price early Thursday more than doubled for a second time this week after the medical device maker said it received clearance from the U.S. Food and Drug Administration to market an insertion device to be used with its implantable contact lenses.

The Monrovia company said its Epiphany Injector System paves the way for the future introduction of a preloaded injector to enable even more minimally invasive procedures in the United States than now available. The company said shipments of the product should begin in July.

Staar makes ophthalmic products to correct nearsightedness, farsightedness and astigmatism. The company on Tuesday announced European regulators had approved a similar system that more easily implants lenses in the eyes of cataract patients. That announcement caused Staar’s stock to double.

The inserter was developed at Staar’s operation in Japan. Epiphany “is an important extension of Staar Japan’s expertise in the area of preloaded delivery systems for foldable (implantable lenses) which have been very successful in the Japanese market,” Chief Executive Barry G. Caldwell said in a statement.

Staar shares were up $1.49, or more than 100 percent, to $2.98 in midday trading on the Nasdaq.

No posts to display