IRVING, Texas, March 12, 2014 – Reata has enrolled the first patient in a Phase 2 study examining the safety and efficacy of RTA 408 Ophthalmic Suspension (0.5% and 1%) in patients undergoing cataract surgery. The study will examine the safety and efficacy of RTA 408 Ophthalmic Suspension for the treatment of ocular inflammation and pain following cataract surgery.
Inflammation and oxidative stress are central to a number of major ophthalmic diseases including allergic conjunctivitis, dry eye syndrome, uveitis, glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy. Further, a growing body of translational research suggests that the impairment of the target of RTA 408, the Keap1-Nrf2 pathway, promotes various ocular diseases, while activation of the Keap1-Nrf2 pathway is protective in a variety of ocular disease models.
More than three million patients undergo cataract surgery each year in the United States, and a significant number of these patients experience post-operative pain and inflammation. If left untreated, post-operative inflammation can lead to scarring, vision loss, or blindness. Topical corticosteroids are the primary treatment for post-operative pain, but they elevate pressure in the eye and promote cataracts. RTA 408 and related analogs have shown significant therapeutic effects in models of post-surgical inflammation.
The Phase 2 study will evaluate the safety and effectiveness of two concentrations of RTA 408 Ophthalmic Suspension with a vehicle control in approximately 100 patients receiving cataract surgery. The trial is a multi-center, double-masked, randomized, dose-ranging, placebo-controlled study consisting of six visits over approximately seven weeks. Study drug will be administered for two weeks after surgery, and the primary endpoints will be a measure of pain four days after surgery and graded markers of inflammation 15 days after surgery. Enrollment is expected to be completed by the third calendar quarter of 2014. For more information on this study, visit: http://clinicaltrials.gov/show/NCT02065375.
About Reata Pharmaceuticals, Inc.
Reata Pharmaceuticals, Inc. is a privately held company aiming to translate innovative research into breakthrough medicines for difficult diseases that have significant unmet needs. Reata is the leader in developing a novel class of drugs with potent transcription-regulating activity called antioxidant inflammation modulators (AIMs). AIMs activate Nrf2, promoting the production of numerous antioxidant, detoxification, and anti-inflammatory genes, and inhibit NF-κB, a transcription factor that regulates many pro-inflammatory proteins. The pharmacology of the AIMs mimics that of endogenous prostaglandin metabolites that are responsible for the orchestrated resolution of inflammation. The anti-inflammatory, cytoprotective and energy metabolism effects of AIM pharmacology have been documented in more than 250 scientific papers and are potentially relevant to a wide range of diseases.
Reata Pharmaceuticals, Inc.