Glaucoma Devices: Progress On Multiple Fronts

The worldwide glaucoma market, worth over $4 billion annually, has been dominated for decades by drug therapy, which accounts for approximately 95% of the total market. The emergence of a high-growth glaucoma device segment based on minimally invasive surgical implants has been anticipated since the middle part of the last decade, but long product development and regulatory approval time lines have delayed the start of this new market cycle. (See Also see "Device Companies Set Their Sights on Glaucoma " - Medtech Insight, 1 October, 2007..) However, the US Food and Drug Administration approval in June 2012 of the iStent Trabecular Micro-Bypass Stent from Glaukos Corp., along with recent progress by a number of companies with competing technologies, is generating renewed interest in glaucoma devices.

The other key milestone from the past two years is Pfizer Inc.’s patent expiration of Xalatan (latanoprost), the world's leading glaucoma medication, which lost patent exclusivity in the US in March 2011 and in Western Europe in January 2012. Before this patent expiration, annual sales of Xalatan totaled $1.7 billion, and the global glaucoma market exceeded $5 billion. The annual sales run rate for Xalatan has declined to approximately $800 million. Other market leaders in the glaucoma medication space include Alcon Inc./Novartis AG, with annual glaucoma sales of $1.3 billion, Allergan Inc. ($1.1 billion), and Merck & Co. Inc. ($0.4 billion). (See Exhibit 1