DRY EYE DISEASE
A Common Disease with Persistantly Disturbing Symptoms.
Dry eye disease is a common inflammatory disease estimated to affect approximately 20 million people in the United States, and is characterized by insufficient moisture and lubrication in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, and in severe cases, decreased vision.
Current Dry Eye Disease treatment challenges.
Only two drugs have been approved by the FDA for the treatment of dry eye disease, and therapy for the disease is generally considered by patients and physicians to be inadequate. Patients with severe cases of dry eye disease may require corticosteroids in addition to approved therapy. Corticosteroids are associated with severe ocular toxicities, including cataract formation and glaucoma (elevation of intraocular pressure that can lead to loss of vision).
THE DRY EYE DISEASE TREATMENT POTENTIAL OF REPROXALAP
In patients with dry eye disease, Reactive Aldehyde Species (RASP) may contribute to ocular inflammation. By diminishing aldehyde levels, Aldeyra's topical ocular aldehyde trap platform represents a novel and differentiated approach that may augment existing therapy, and, in severe cases, reduce or eliminate the need for corticosteroids.
In 2017, we announced positive data from our Phase 2a clinical trial of reproxalap ophthalmic solution in patients with dry eye disease. Relative to baseline, the data indicated that reproxalap clinically improved signs and symptoms of dry eye disease.
In September 2018, Aldeyra announced positive data from our Phase 2b clinical trial of reproxalap ophthalmic solution in patients with Dry Eye Disease. Statistically significant improvement across multiple symptom and sign measures along with early onset supports a differentiated product profile. Based on these results we intend to progress Reproxalap into phase 3 for this indication in 2019.