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Phase 2b BAYnovation Study for the Treatment of Viral Conjunctivitis Includes 60 Clinical Sites Worldwide
EMERYVILLE, Calif., Jan. 3, 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 that the first patients have been enrolled in India into its global Phase 2b BAYnovation clinical study, investigating NVC-422 Ophthalmic Solution as a treatment of adenoviral conjunctivitis, a highly contagious form of "pink eye" for which there is an unmet ocular medical need.
BAYnovation is a multi-centered, randomized clinical study expected to enroll approximately 450 patients with confirmed adenoviral conjunctivitis throughout the United States, India and Brazil. The study will be conducted in over 60 clinical trial sites worldwide, with 24 sites in India. BAYnovation is designed to evaluate NVC-422's efficacy in eliminating the adenoviral infection, specifically treating the associated red eye, clearing the blurred vision, and reducing lingering effects left by the adenoviral conjunctivitis. Enrollment is now underway in both U.S. and India, and is expected to be initiated in Brazil. Clinical data results are expected in the second half of 2013.
"Because the adenovirus can remain active for weeks, adenoviral conjunctivitis is highly contagious and has been known to lead to outbreaks of epidemic proportions in India," stated Prashant Garg, MD, L V Prasad Eye Institute, Hyderabad, India. "NVC-422 Ophthalmic Solution would be a welcome addition within our treatment regimen, as there is no available cure for adenoviral pink eye. Treatments usually deal with relieving irritation and discomfort, and patients must suffer with the infection until it plays its course. Meanwhile, they are spreading the infection to those around them."
Dr. David Stroman, Ph.D., Senior Vice President, Ophthalmology at NovaBay Pharmaceuticals, stated, "We are pleased to see that enrollment in the BAYnovation global study is underway in India and believe that the country's participation will prove invaluable in completing the trial. With previous clinical experience from the Phase 2a trial showing the compound to be effective in eliminating the virus, we are hopeful that NVC-422 Ophthalmic Solution will represent a significant advancement in the treatment of adenoviral conjunctivitis."