Deep and Innovative Pipeline
Focused on Immune-Mediated Diseases
Reproxalap ophthalmic solution for ocular inflammation.
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. 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). In patients with dry eye disease, pro-inflammatory aldehyde mediators 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, in April 2019 Aldeyra initiated the RENEW Phase 3 clinical trial of topical ocular Reproxalap for the treatment of Dry Eye Disease.
Allergic conjunctivitis is a common inflammatory ocular disease that is thought to be mediated in part by aldehydes. Patients with allergic conjunctivitis have ocular itching, excessive tear production, swollen eyelids, and ocular redness. Some patients with allergic conjunctivitis do not respond adequately to antihistamines (the current standard of care), and are then treated with topical corticosteroids, an anti-inflammatory medication that can lead to cataracts, glaucoma, ulcers on the front of the eye, and increased rates of ocular infections. Thus, there is a need for novel and safe medicines like reproxalap that have demonstrated activity in mitigating the symptoms of allergic conjunctivitis.
Noninfectious anterior uveitis is a rare but severe and poorly treated ocular disease where aldehydes are associated with inflammation, fibrotic changes and lipid destruction that lead to surface irritation, pain, photophobia, redness, and in some cases, blindness. Since Corticosteroids are currently used for treatment of uveitis, there is a considerable medical need for a safer therapeutic alternative such as reproxalap. We announced positive data from our Phase 2 clinical trial of reproxalap ophthalmic solution and started enrollment for Phase 3 in patients with noninfectious anterior uveitis. Reproxalap reduced cell count in a manner comparable to standard-of-care topical corticosteroids, which are effective but toxic, leading to glaucoma and cataracts in many patients. Together with the positive data in allergic conjunctivitis, these results suggest that reproxalap could be active in a broad array of inflammatory ocular diseases.
Reproxalap TOPICAL MEDICATION FOR THE DERMATOLOGICAL MANIFESTATIONS OF SJÖGREN-LARSSON SYNDROME
As reproxalap has demonstrated fatty aldehyde sequestration in human skin cells in preclinical studies, Aldeyra initiated a clinical trial of reproxalap for the treatment of the dermatologic manifestations of Sjögren-Larsson Syndrome (SLS) in the form of a topical medication. Our goal is to improve the symptoms of the severe skin disorder called ichthyosis, which is believed to result from the aldehyde accumulation inherent in SLS. There is currently no FDA-approved therapy specifically for SLS.
We announced positive data from our randomized, vehicle-controlled, double-masked clinical trial of topical dermatologic reproxalap to treat the skin disease in patients with SLS. The skin of all reproxalap-treated patients improved, and the magnitude of improvement was statistically greater than that of vehicle-treated patients. The results of the clinical trial suggest that reproxalap could be the first mechanistically directed therapy in SLS.
The Development of a Systemic RASP* Scavenger
Aldeyra is developing other product candidates for autoimmune and metabolic diseases, as a systemic application of our RASP platform.
*RASP: Reactive Aldehyde Species that are Pro-inflammatory