OCU310 as a Treatment for Dry Eye Disease
OCU310 is a repurposed drug with an established safety track record that is being developed under the FDA’s 505(b)(2) regulatory pathway for the treatment of dry eye disease. Ocugen is conducting a proof of concept study under an approved IND for OCU310 (brimonidine/steroid combination therapy), as a topical formulation for the treatment of dry eye disease. This randomized, placebo-controlled, double-blind, multi-center, proof of concept study will assess the tolerability and preliminary efficacy of OCU310 in adult men and women with a diagnosis of dry eye disease. This study will explore the most appropriate endpoints for future pivotal studies.
About Dry Eye Disease
Dry eye disease is a common ocular disorder involving the aberrant production and stability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort. Common signs and symptoms of dry eye disease include: eye redness, ocular pain, burning and stinging sensation, foreign body sensation, itchy or scratchy eye sensation, tired eyes, enhanced eye pressure, and painful mucous discharge.
Dry eye disease affects approximately 29 million adults in the US and its prevalence increases with age, especially in women. The most common causes of dry eye are contact lens usage, autoimmune disorders, systemic drug effects, and refractive surgeries, particularly in middle-aged and older adults. Dry eye disease also occurs in a higher percentage of women than men, especially in women entering menopause or pregnancy; hormone imbalances during menopause or pregnancy can cause lacrimal gland and ocular surface inflammation and tear film abnormalities.
Currently there are approximately 14 million patients diagnosed with dry eye disease. There are only two pharmaceutical agents that are FDA approved for the treatment of dry eye: Restasis® (cyclosporine ophthalmic emulsion) and XiidraTM (lifitegrast ophthalmic solution) which treat 1 million patients today. Given the complexity, severity, and frequency of dry eye disease, and given the limited modes of action by which these two compounds treat dry eyes, there is a medical need for other dry eye therapies, particularly those with multiple modes of action that target the wider dry eye population and are effective and safe for long-term daily use.