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Ocular Surface Disease

Ocular surface disease encompasses a variety of disorders that affect the surface of the eye (the conjunctiva and cornea). Among the most prevalent of these conditions is dry eye disease (DED) or “dry eye.” Aerie’s first program in ocular surface disease is focused on the development of the TRPM8 agonist AR-15512 for the treatment for dry eye.

An international consensus report describes dry eye as a “multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neuro-sensory abnormalities play etiological roles.”1

It is estimated that more than 30 million people in the United States may suffer from dry eye.2 However, most have not been formally diagnosed and fewer still, as little as 10%, are receiving treatment.  This is despite the impact that symptoms of the condition can have on vital, daily activities including working, reading, and driving at night, as well as on overall quality of life. As the U.S. population ages and the use of contact lenses, computers, smartphones, and tablets increases, the prevalence of dry eye continues to rise.

Addressing the Need

Treatment of dry eye is mainly symptomatic. Over-the-counter artificial tear preparations are generally the first therapy considered. Only three specific pharmacological therapies are currently approved in the United States. These agents employ various mechanisms for targeting the underlying ocular inflammation associated with DED, with two products indicated for increased tear production in patients with DED and a third indicated for the treatment of the signs and symptoms of DED. In general, each product is associated with poor compliance due to delayed relief and poor tolerability.

The evolving understanding of dry eye has brought to light that factors beyond inflammation play a central role in disease etiology and progression. This, in combination with the limited effectiveness of current therapies, leaves a significant unmet need for therapies that address other underlying causes of dry eye, while offering relief of both symptoms (what the patient experiences) and signs (what is clinically observable) in a rapid and well-tolerated fashion. New agents that meet these criteria could provide additional options for both monotherapy and combination therapy and might encourage a greater proportion of dry eye sufferers to seek and receive treatment.

  1. Craig et al. TFOS DEWSII Report. Ocular Surface 2017.
  2. https://www.tfosdewsreport.org/
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