Alcon, Inc. (NYSE: ACL) and its partner, NovaBay Pharmaceuticals, Inc. (NYSE-AMEX: NBY), announced that Alcon has begun treating patients in a Phase 2 clinical trial of NovaBay’s patented lead Aganocide® compound, NVC-422, for viral conjunctivitis, a type of “pink eye.” Conjunctivitis is a pervasive and painful condition that affects both adults and children, leading to more than four million doctor and emergency room visits in the United States each year.

NovaBay has a licensing and research collaboration agreement with Alcon, the world’s leading eye care company, for use of its Aganocide® compounds in the eye, ear and sinus, and in contact lens solutions.

Developed by NovaBay to mimic the body’s defense against infection, Aganocides® are proprietary synthetic analogs of the same molecules used by white blood cells to destroy harmful microbes in the body, such as viruses and bacteria. Because of their natural mechanism of action, NovaBay believes that Aganocide® compounds have a low potential for generating microbial resistance, offering a potential solution to the problem of rising resistance of microbes to traditional antibiotics.

The Phase 2 viral conjunctivitis study follows a recently completed Phase 1 trial in which safety and tolerability were successfully demonstrated in 120 healthy volunteers with no reported serious adverse events.

“We are pleased to be entering mid-stage clinical testing for viral conjunctivitis,” said Ron Najafi, Ph.D., chairman and chief executive officer of NovaBay. “This is the first step in the ophthalmic clinical development program for NVC-422, which has the immediate goal of developing the first effective product to address viral conjunctivitis for which there are limited treatment options.”

The Phase 2 multi-center, randomized, placebo-controlled trial is designed to determine the safety and efficacy of NVC-422 in people with viral conjunctivitis. The study calls for enrolling approximately 250 patients at more than 30 medical centers, mostly in the United States.

“This study is an important step forward with the clinical program for this potentially dual-acting therapy to address the multiple causes of conjunctivitis. Dual action against viral and bacterial conjunctivitis is important because when an infection is diagnosed it is difficult, time-consuming and expensive to determine the underlying cause of the infection and treat it properly,” said Dr. Sabri Markabi, M.D., Alcon’s senior vice president of research and development and chief medical officer.

About Conjunctivitis

Conjunctivitis, which can result from either viral or bacterial infection, is an inflammation of the thin, clear tissue that covers the white part of the eye and forms the inside lining of the eyelid. The viral disease is principally caused by adenoviruses, but also can be caused by other viruses, such as enterovirus. There is no specific treatment for adenoviral conjunctivitis, which can take up to three weeks or longer to clear on its own. Bacterial conjunctivitis is caused by a variety of bacteria and is largely treated with topically applied antibiotic eye drops. Regular innovation to develop newer antibiotics is required because over time antibiotics may encounter increasing bacterial resistance.

About Aganocide® Compounds

The Aganocide® compounds are novel, proprietary, synthetic N-chlorinated antimicrobial molecules specifically developed by NovaBay to mimic the body’s natural defense against infection. The Aganocide® compounds maintain the biological activities while improving the stability of naturally occurring N-chlorinated antimicrobial molecules. These highly differentiated compounds may deliver the same or better efficacy than currently used antibiotics without contributing to the growing rise of antibiotic-resistant bacterial strains. In preclinical testing, the Aganocide® compounds have been shown to be highly effective against bacteria, viruses and fungi. They also have been demonstrated to be effective against bacteria in biofilms, which render most antibiotics ineffective. Aganocides have a broad therapeutic index while providing a high degree of potency, good tolerability as well as dosing versatility and flexibility.

About Alcon

Alcon, Inc. is the world’s leading eye care company, with sales of approximately $6.3 billion in 2008. Alcon, which has been dedicated to the ophthalmic industry for more than 65 years, researches, develops, manufactures and markets pharmaceutical products, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. For more information on Alcon, Inc., visit the Company’s web site at http://www.alcon.com.

Source
NovaBay Pharmaceuticals

Southampton’s university hospitals are to take part in clinical trials of a vaccine that could protect against numerous types of flu - including pandemics such as bird and swine flu.

Existing vaccines target only the outside of the flu virus, which frequently changes and varies in different strains of the virus, meaning new vaccines are needed each year.

Novel new T-cell vaccines target the internal core of the flu viruses, which do not change very much over time or between strains.

The study is being conducted by research staff and clinicians based at the Wellcome Trust Clinical Research Facility (WTCRF) at Southampton General Hospital and the Jenner Institute at Oxford University.

“The current approach to tackling flu via the coat of the virus is not adequate because strains are constantly changing, new formulas have to be developed at short notice and then people are only protected for that particular strain,” said Dr Saul Faust, director of the WTCRF in Southampton.

“If successful, this new type of vaccine that targets the inside of the virus, as opposed to the shell, could potentially offer protection against many different strains of influenza A, including those that cause pandemics.”

Dr Faust, a specialist in infectious diseases, added: “Such an advanced vaccine would be suitable for all ages at any time of year and, as the substance of the vaccination would not change from year to year, there would be no need for annual injections.”

Three hundred healthy volunteers aged between 18 and 45 are required to take part. Initially, volunteers will have a blood test to see if they are immune to a particular strain of flu and 26 people who do not have this immunity will then go ahead to trial the new vaccine in the second part of the study.

Source
Southampton University Hospitals NHS Trust

Genentech, Inc. announced that the Phase III study BRAVO showed Lucentis® (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to branch retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Retinal vein occlusion (RVO) is a common cause of vision loss that occurs when blood flow through a retinal vein becomes blocked, such as by a blood clot.

BRAVO evaluated the safety and efficacy of six monthly injections of Lucentis compared to monthly sham injections. The two doses of Lucentis studied showed a statistically significant improvement in best-corrected visual acuity (the best vision a person can achieve with an eyeglass or contact lens prescription) at six months compared to sham. Full results will be presented at the Retina Congress, September 30 to October 4, 2009, in New York.

“RVO is a devastating disease and there are no FDA-approved medicines shown to improve vision for six months,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We are excited that another pivotal study has demonstrated the important role Lucentis can play in improving vision in people with difficult-to-treat eye disease, and look forward to the results of CRUISE, a Phase III trial in central-RVO in the third quarter of this year.”

About RVO

RVO occurs when blood flow through a retinal vein becomes blocked, causing swelling (macular edema) and hemorrhages in the retina, which may result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with RVO. RVO can affect people across a wide range of ages, from young, working-aged adults to the elderly.

There are two main types of RVO: branch-RVO, which affects an estimated 684,000 people, and central-RVO, which affects an estimated 211,000 people in the United States.1 Branch-RVO occurs when one of the branches of the main vein of the eye becomes blocked. Central-RVO occurs when the main vein of the eye, located at the optic nerve, becomes blocked.

About BRAVO (FVF4165g)

BRAVO is a multicenter, randomized, double-masked, sham injection-controlled Phase III study, designed to assess the safety and efficacy of Lucentis in treating macular edema secondary to branch-RVO. Patients (n=397) were enrolled at 93 clinical trial sites across the United States.

The 12-month study consists of a six-month, sham-controlled treatment period, followed by a six-month observation period (during which all participants were eligible to receive Lucentis as needed). During the first six-month period, participants received monthly injections of one of two different doses (0.3 mg or 0.5 mg) of Lucentis (n=265) or monthly sham injections (n=132). The study was not designed to compare the two doses of Lucentis. Rescue laser treatment was available starting at month three to all patients meeting pre-specified criteria. The primary endpoint was the mean change from baseline in best-corrected visual acuity score at six months compared to sham.

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (AMD). Lucentis is the only FDA-approved treatment for wet AMD proven to improve or maintain vision. In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) in those trials treated monthly with Lucentis maintained vision.

Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula, which is the portion of the eye responsible for fine, detailed central vision.

Lucentis is a prescription medication given by injection into the eye. Lucentis has been associated with detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. Increases in eye pressure have been seen within one hour of an injection. Although uncommon, conditions associated with eye- and non-eye-related blood clots (arterial thromboembolic events) may occur. Serious side effects included inflammation inside the eye and, rarely, effects related to the injection procedure such as cataract. The most common non-eye-related side effects were nose and throat infection, headache, and respiratory and urinary tract infections. The most common eye-related side effects were the feeling that something is in a patient’s eye, and increased