Menicon America’s Lagado Corp. Receives FDA Clearance for New Latheable Silicone Hydrogel Material

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ENGLEWOOD, Colo.—Lagado Corporation, a wholly owned subsidiary of Menicon America, Inc., announced that it has received U.S. Food & Drug Administration (FDA) clearance for Lagado LSH (mangofilcon A), a new silicone hydrogel material for use in contact lenses. The company was notified of the approval on May 14.

Formulated to meet the growing demand for made-to-order silicone hydrogel lenses, the company said in a statement, “This mid-range water content (49 percent) material can be used in a wide variety of designs. Lagado LSH lenses will be plasma oxidized to produce a low wetting angle and improved wettability—helping to promote lens comfort, improve visual performance, and reduce the potential for deposits. Additionally, the LSH material has a unique combination of physical properties that make it stable, durable and easy to handle.”

Added Lagado’s Bill Hoffman, chief scientist, “Lagado LSH was formulated to achieve the ideal balance between custom manufacturing requirements and clinical needs. It will enable specialty contact lens fitters and their approved custom lens laboratory to address a wide range of conditions.”

In the U.S., the company will begin working closely with a select group of independent, custom lens laboratories. Each lab is required to submit and receive FDA clearance for lenses offered in the Lagado LSH material. The company anticipates Lagado LSH lenses becoming available later this year.

Founded in 1999, Lagado serves custom contact lens laboratory manufacturers, eyecare practitioners and patients worldwide with a full range of gas permeable lens materials and soft contact lens polymers. The company was acquired by Menicon America, Inc. in June 2010.

Menicon Co., Ltd., founded by Mr. Kyoichi Tanaka in 1951, is Japan's first and largest contact lens manufacturer and now is represented in over 80 countries. In North America, Menicon is best known for the hyper Dk Menicon Z material and Rose K, frequently prescribed lenses for keratoconus. In 2011, Menicon America, Inc. introduced to the U.S. market, the Menicon GP lens care system consisting of Menicon Unique pH, Menicon PROGENT, and Menicon Rewetting Drops and an e-commerce, WebStore model designed specifically for practitioners and their patients.