CHAPEL HILL, N.C., US and VOUVRY, VALAIS, Switzerland, Jan. 16 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the initiation of a Phase III clinical trial with VISMED(R) in dry eye syndrome. The corresponding protocol was negotiated with the FDA under the Special Protocol Assessment (SPA) program and consists of a multi-center, randomized, controlled and double-blinded study. VISMED(R) is a patented formulation containing sodium hyaluronate, currently marketed to millions of dry eye syndrome sufferers in Europe by TRB Chemedica. VISMED(R) is being studied in the US as a treatment for dry eye syndrome, under IND 73,441 filed in June 2006. The SPA was cleared by FDA in December of 2006 and the first patients were enrolled in the study immediately thereafter. If the current Phase III study is successful Lantibio expects to file a New Drug Application (NDA) for VISMED(R) in 2008.
In dry eye syndrome, it is hypothesized that VISMED(R), administered via ocular instillation, will hydrate the surface of the eye preventing dryness and long-term ocular injury. The sodium hyaluronate present in VISMED(R) is a known natural molecule with viscoelastic properties that lubricates the eye and hydrates the ocular surface. Several pre-clinical and clinical studies were performed previously in Europe with VISMED(R) indicating the safety and efficacy in relevant objective and subjective endpoints.
"During 2006, we engaged in multiple meetings with the FDA's Division of Anti-Infective and Ophthalmology Products where we were able to fully vet VISMED(R)'s background data on as well as agree on plans for the eventual NDA submission. We have high confidence in the ultimate success of VISMED(R)," said Dr. Luis Molina, President and CEO of Lantibio, Inc.
Dr. Guido Di Napoli, President of TRB Chemedica added, "I am very proud that our association with Lantibio is progressing so successfully, and I am now looking forward to the completion of the next regulatory steps so as to make VISMED(R) available to the US market as soon as possible. I strongly believe VISMED(R) will improve the quality of life of many patients in the US, as it has done for so many European patients already. TRB Chemedica International SA is continuously working to bring new generations of ophthalmic products on the market."
The most common causes of dry eye syndrome are hormonal changes in menopause, ocular surgery, and environmental factors such as dust and pollutants. In addition, Sjogren's syndrome patients suffer dry eyes and dry mouth. Sjogren's syndrome is one of the most prevalent autoimmune disorders, striking as many as three million Americans. Symptoms of dry eye syndrome also include burning, itching, irritation, photophobia, and a feeling that there is a foreign body in the eye. If left untreated, it can cause permanent damage, including impaired vision.
In 2003, Morgan Stanley Research estimated the prevalence of dry eye syndrome in the United States at 5.5 million diagnosed cases. More than 90% of Sjogren's syndrome sufferers are women and while prevalence increases with age, the average age of onset is in the late 40's.
Lantibio, Inc. is a development pharmaceutical company focused on the discovery, development, and marketing of products for the treatment of ocular disease and serious respiratory conditions.
About TRB Chemedica
TRB Chemedica is a privately-owned Swiss pharmaceutical company with more than 20 years experience in research, development, manufacture and commercialization of innovative niche products in rheumatology, ophthalmology and neurology. TRB Chemedica has developed an expertise on the viscoelastic biopolymer, hyaluronic acid, manufacturing sterile finished products in its Swiss-based GMP facility. The company's product pipeline will help to fuel growth in each of the targeted therapeutic areas as well as introduce it into new areas of therapeutic focus. TRB Chemedica products are currently sold in more than 40 countries worldwide through wholly-owned subsidiaries, present in various countries in Europe, South America and Asia, and a growing network of licensing and distribution partners.
This press release might contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Lantibio's and/or TRB Chemedica's expectations and projections. Risks and uncertainties include success of clinical trials for Lantibio's products, intellectual property risks, need for additional financing or capital, ability to develop and successfully commercialize our products, ability to enter into licensing agreements, and the ability of the competition to render Lantibio's product candidates or technologies obsolete or noncompetitive. Lantibio and TRB Chemedica assume no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.