BAYnovation Phase 2b Trial for the Treatment of Viral Conjunctivitis Spans Three Continents
EMERYVILLE, Calif., April 8, 2013 (GLOBE NEWSWIRE) -- NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY), a biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with first-in-class compounds such as its proprietary Aganocides®, today announced the enrollment of the first patients in Brazil into its global Phase 2b clinical trial, BAYnovation. The trial is investigating Auriclosene (NVC-422) Ophthalmic Solution as a treatment for adenoviral conjunctivitis, a highly contagious form of "pink eye" for which there is no approved treatment anywhere in the world.
BAYnovation is a multi-centered, randomized clinical study expected to enroll approximately 450 patients with adenoviral conjunctivitis throughout the United States, India and Brazil. The study is being conducted by over 60 clinical Investigators worldwide, including approximately 11 sites in Brazil and 24 sites in India.BAYnovation is designed to evaluate the efficacy of Auriclosene Ophthalmic Solution in treating the adenoviral infection, specifically clearing the associated red eye, blurred vision, and reducing lingering effects left by the infection. Clinical data results are expected in the second half of 2013. Prof. Dr. Rubens Belfort, Jr., Professor, Federal University of São Paulo and President SPDM, Hospital Sao Paulo, said, "Adenovirus has caused large epidemics of pink eye in Brazil, and the ocular infections caused by these strains causes blurred vision which can last for weeks to years. We are very pleased to be a part of this global clinical study. A treatment for adenoviral conjunctivitis is badly needed to combat the epidemics caused by adenovirus." Dr. David Stroman, Ph.D., Senior Vice President, Ophthalmology at NovaBay Pharmaceuticals, said, "With the enrollment of patients in Brazil, our global BAYnovation study now has active sites on three continents, as planned. Patients with adenoviral conjunctivitis in the U.S., India, and Brazil are actively participating in the development of this important new product. Because of the design features of BAYnovation, we are assessing the clinical and virological effectiveness of auriclosene as well as assessing its ability to reduce the sight-threatening effects of the infection."