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Glaucoma Devices: Progress On Multiple Fronts

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.

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...

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