discovering dry eye
Dry Eye Treatments: A Money-Making Venture?
BY KELLY KINNEY NICHOLS, OD, MPH, PHD

Researchers speculate that approximately 12 million Americans have dry eye syndrome. Assuming that these 12 million Americans would benefit from a dry eye treatment, one can imagine the dollar signs in any pharmaceutical company's eyes as it dreams of its product "hitting it big." This is not to say that pharmaceutical companies do not care about patients, they do. Teams of researchers and investigators plan studies and recruit patients, all in the hopes that the treatment being tested will be helpful to patients with the disorder. As clinicians in the trenches with patients, we hope new treatments for eye diseases work as well.

On the other hand, if a dry eye patient purchases artificial tears on a regular basis (one $8 bottle per month), the cost per year for tears is approximately $100. If all 12 million Americans with dry eye purchase tears regularly, the spending on OTC tear preparations would be $1.2 billion dollars. If Allergan or Inspire Pharmaceuticals are successful in achieving FDA approval for the therapeutic drops currently in clinical trials, the money generated from selling a $20 to $30 (speculated) bottle of prescription eye drops for dry eye could be staggering.

Optimistically, if some of my more severe dry eye patients could be helped even a little with chronic discomfort, blurry vision and risk for ocular surface infection, then I applaud the efforts of any company that is able to get such a medication approved.

Herbal Therapies

Herbal supplements are revered by some and thought of as hocus-pocus by others. Part of the reason for the mystery behind herbal supplements is that the FDA does not monitor herbal supplements as rigorously as drugs; therefore, thorough studies of the efficacy and safety of herbal supplements are often not performed or reported in the scientific literature.

Times are changing. Recently, the Age Related Eye Disease Study announced the findings of a clinical trial looking at the beneficial effects of antioxidants and zinc in patients at risk for macular degeneration. While this is not related to dry eye, it does demonstrate that the scientific evaluation of supplements in relation to eye disease is important.

Recently, a press release from TheraLife, Inc., a company involved in the development of botanical drugs, announced the results from a six-site, double-blind, placebo-controlled clinical trial of an oral supplement for the treatment of dry eye and eye strain conditions. According to the company's web page (www. theralife.com), the herbal ingredients increase circulation to ocular tissue, improve tear quality and maintain healthy function of the lens and retina. The results of the study indicate "high clinical efficacy" for these conditions in as soon as one week. According to the company, the oral therapy offers substantial advantages over conventional treatments, including eyedrops, such as artificial tears, and punctal plugs. The company plans to submit its findings to the FDA shortly. To date, there have been no reports in the literature regarding the study design or results.

TheraLife reports that more than 70 percent of the 75 million Americans who work on computers daily suffer eye- or vision-related problems and that the National Academy of Sciences estimates these injuries cost companies $45 to $50 billion each year. TheraLife Eye costs $25 per bottle of 24 capsules. Assuming one capsule is taken per day, the cost per year per person would be $380. For this cost, does the public have a guarantee that they work?

As eyecare professionals, we have a duty to our patients to make recommendations and answer questions based on our expertise and knowledge. Read peer-reviewed literature, stay current, and give sound advice to your patients. They will thank you for it.

Dr. Nichols is assistant professor of clinical optometry at The Ohio State University College of Optometry in the area of dry eye research.