Medennium, an Irvine medical device company, said it has received approval from Health Canada to market its SmartPlug dry eye treatment in the country. The company said it has retained distributor I-MED Pharma to handle its product in Canada.
Separately, the company said it received a CE mark from the European Union for SmartPlug. The approval means the company’s device can be sold throughout the union.
Medennium’s SmartPlug is designed to treat dry eye without potential irritation and discomfort of conventional rigid punctum, or tear drainage duct, plugs.
The SmartPlug is made of thermodynamic acrylic polymer that is a thin rigid rod when removed from the package. The plug then transforms itself into a soft gel-like, long-term plug that conforms itself to the patient’s tear drainage duct.
Approximately 7.5 million people in the U.S. suffer from moderate to severe dry eye, with an estimated 15 million to 20 million who suffer from milder forms of the condition. Five million people are unable to wear contact lenses because of dry eye.
Medennium was formed in 1999 when International Vision Inc. merged with Medennium to develop and introduce ophthalmic products to be made from patented polymers. Medennium has gone from 30 to 70 employees in less than two years, and received a 10% equity investment from CIBA Vision, the eye care unit of Swiss pharmaceutical behemoth Novartis AG.
