Anyone reading Glaucoma Today knows that some 3 million Americans suffer from this neurodegenerative disease. Thanks to its size, this market continues to attract extensive investment in drug development, which has provided physicians and their patients with highly effective glaucoma medications for decades. Unfortunately, these agents neither cure the disease nor fully arrest its progression. Thus, there is still work to be done to develop either a cure or a more robust treatment for glaucoma.

In the late 1990s, with the sale of Chiron Vision to Bausch + Lomb (Rochester, NY), I transitioned from running companies to working in venture capital. As a founder and managing director of Versant Ventures (Newport Beach, CA), it has been my privilege to lead the investment in more than 20 early-stage health care companies. Sixteen of these have been in the ophthalmic field, with four focused on glaucoma. I have primarily invested in early-stage medical device and drug-delivery companies, so it is from this perspective that I share my views.

AN EMERGING FOCUS ON SURGICAL TREATMENTS AND TECHNOLOGIES

In the past decade or so, there has been increasing interest and investment in novel technologies focused on treating glaucoma surgically. The mission is to bring minimally invasive technologies to the glaucoma specialist and anterior segment surgeon that safely and effectively treat the disease. More than half a dozen new companies have been created. The focus of several of them is the development of easily implanted microstents to provide aqueous outflow channels. These devices are designed to lower IOP continuously for years, and their benefits may include 24-hour performance with little if any diurnal variation. Success in this area would lessen the burden of adherence on patients. These devices are not expected to replace glaucoma medications. If they can delay or reduce patients' need for medication, however, they could render glaucoma therapy more effective and improve patients' quality of life.

A CHALLENGING PATH TO US APPROVAL

The challenges of developing and bringing new medical devices to the US market are not trivial. Companies spend years on technical development and proof-of-concept clinical trials. This research is conducted at high-quality clinical sites outside the United States due to the burdensome regulatory environment in this country. After patient-selection criteria, the device's performance, and surgical techniques are well characterized, an early-stage company—if well funded—turns its focus to the US market.

The clinical study protocol that will be the basis of premarket approval must be negotiated with the FDA. Without faulting the FDA or industry, I can state that this process is cumbersome and that it significantly delays the release of new medical technologies on the US market. In November 2010, prominent med-tech entrepreneur Josh Makower, MD, designed and conducted a survey of 200 US med-tech companies to examine the impact of the current regulatory environment on innovation in the field of medical devices. On average, he found that patients in Europe gain access to new therapies 2 years before patients in this country due to regulatory challenges. Full details of the study are available on the Medical Device Manufacturers Association's Web site (www.medicaldevices.org).

I am hopeful that this situation will change for the better. The FDA and people in influential positions in Washington appear to be seeking ways of improving the process.

COST-EFFECTIVENESS OF NEW SURGICAL TECHNOLOGIES FOR GLAUCOMA

As yet, the cost-effectiveness of miniature, surgically implanted outflow technologies is unknown. This important quality must be carefully assessed. If such devices provided a multiyear IOP-lowering effect, they could be quite cost-effective.

OUTLOOK

In this decade, I anticipate that emerging surgical technologies will have a substantial impact on the treatment of glaucoma. If these new devices prove successful, the beneficiaries will be patients and physicians, particularly glaucoma specialists and anterior segment surgeons. These technologies will partner with and bolster current and future drug therapies.

William J. Link, PhD, may be reached at (949) 729-4500; blink@versantventures.com.