Viral conjunctivitis is a highly contagious infection, often causing major ophthalmic epidemics. There is no approved acute treatment currently approved by the FDA for viral conjunctivitis. A safe broad-spectrum antiviral agent is needed to treat this unmet medical need.
NVC-422, a new generation N-chlorotaurine-based molecule with excellent solution stability, recently demonstrated has broad-spectrum in vitro virucidal activity against major ophthalmic viral pathogens including adenovirus, coxsackievirus, enterovirus and HSV-1. NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY),which created the proprietary NVC-422 molecule, is currently conducting a global Phase 2b trial to investigate a formulation of NVC-422 to treat viral conjunctivitis. Data from this study is expected in the second half of 2013.
The study, 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.”
NovaBay is a biotechnology company focused on addressing the global anti-infective market with its proprietary and patented Aganocide(R) compounds (lead: NVC-422), which mimic the body’s natural infection fighting processes, do not give rise to antibiotic resistance, and can address the $21 billion anti-infective worldwide market. These novel, synthetic compounds prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance.