Glaucoma Devices: Progress On Multiple Fronts

Article preview from Medtech Insight - April, 2013

Recent progress on the US regulatory front is generating renewed interest in device-based glaucoma therapies, which potentially could grow to a multibillion-dollar industry. The list of companies targeting this space continues to expand, as does the variety of potential device-based solutions: the current pipeline includes several innovative and less invasive products and technologies designed to improve surgical outcomes, a growing number of advanced drug-delivery inserts to address the patient noncompliance issue that is so common in this arena, and some unique patient monitoring devices.

Glaucoma Devices: Progress On Multiple Fronts

Article preview from Medtech Insight - April, 2013

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 "Device Companies Set Their Sights on Glaucoma " — Medtech Insight, 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.) Latanoprost is the most widely prescribed of the prostaglandin analogs, which are dosed once daily and represent first-line glaucoma therapy in most of the developed world. Although there has not been a new class of drugs approved for glaucoma since the introduction of latanoprost 17 years ago, the genericization of this gold-standard drug is important because it raises the cost-effectiveness hurdle for all new glaucoma drug and device therapies under development.

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