OCU310 is a differentiated, topical therapy being developed as a treatment for dry eye disease. It is a proprietary ophthalmic nanoemulsion of the anti-nociceptive and anti-inflammatory properties of brimonidine, an FDA-approved drug with established safety for ocular use, enabling Ocugen to develop OCU310 under the accelerated 505(b)(2) regulatory pathway, which allows rapid progression to pivotal clinical studies. If approved, OCU310 is expected to have significant advantages compared to currently marketed products for dry eye disease, including a more rapid onset of action, alleviation of ocular pain and photophobia, as well as a rapid reduction in surface swelling and discharge.
A randomized, placebo-controlled, double-blind, multi-center, Phase 2 proof of concept study to assess the tolerability and preliminary efficacy of OCU310 in adult men and women with dry eye disease has been completed. This purpose of this study was to explore the most appropriate endpoints for future pivotal studies. Ocugen expects to commence Phase 3 clinical studies for OCU310 in the second half of 2018.
About Dry Eye Disease
Dry eye disease is a common yet under-diagnosed ocular disorder. According to the National Eye Institute, experts estimate that dry eye syndrome affects millions of adults in the United States.1 One estimate reports that up to 20 million Americans suffer from dry eye symptoms while a recent study suggests that over 16 million adults in the US have diagnosed dry eye disease.2,3
Its prevalence increases with age, and is more common in women, especially women entering menopause or pregnancy due to associated hormone imbalances that can cause ocular inflammation and tear film abnormalities.
The most common causes of dry eye disease are contact lens usage, autoimmune disorders, systemic drug effects, and refractive surgery, which can lead to aberrant production and stability of tear film. The resulting damage to the ocular surface is correlated with the common signs and symptoms of dry eye disease: 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.
There are only two FDA-approved products for dry eye disease: Restasis® (cyclosporine ophthalmic emulsion) and Xiidra® (lifitegrast ophthalmic solution), which combined address only about 1 million of the 16 million diagnosed patients today. Given the complexity, severity, and frequency of dry eye disease, and given the limited modes of action of currently approved products, there remains a medical need for new dry eye therapies, particularly ones with multiple modes of action that may be effective for a wider patient population and are safe and well tolerated for long-term daily use.
1 National Eye Institute website, https://nei.nih.gov/health/dryeye/dryeye (accessed Oct 20, 2017)
2 Market Scope. Report on the Global Dry Eye Market. St. Louis, MO: Market Scope; 2004.
3 Farrand K. et al, American Journal of Ophthalmology, Oct 2017