SIFI to strengthen R&D Pipeline with Pro-Ocular™ containing a neurosteroid with novel dosage delivery system that activates neural signaling to produce endogenous tear film without need for eye instillation
SIFI, Italian leader in the development of therapeutic solutions to treat ophthalmic disorders, and GLIA LLC, pharmaceutical development company based in Boston, are pleased to announce they have agreed to a new collaboration, focused on the development of Pro-Ocular™ containing a neurosteoid delivered innovatively to activate neural signaling without need for eye instillation, for the treatment of signs and symptoms of dry eye disease. The agreement grants exclusive rights to SIFI for the development, registration and marketing of the product candidate throughout all European markets.
Dry eye disease is one of the most frequent causes of patient visits to eye care practitioners, and has become a global unmet need, afflicting over 30 million people in the United States alone and at least 344 million people worldwide. 1 Dry eye syndrome is growing also among children and adolescents, and the World Health Organization has recently defined it as one of the most ignored and undervalued pathologies of the modern age. It is in fact a multifactorial disease that affects the tear film and ocular surface and causes symptoms of discomfort, visual disturbances and instability of the tear film, with potential damage to the ocular surface, accompanied by an increase in tear film osmolarity and ocular surface inflammation. In addition, activities related to the use of smartphones, tablets and any kind of digital device, if excessive and employed at a very close distance to the eyes, may significantly alter the production of tear film.
Pro-Ocular™ has the potential to become an innovative therapy in the treatment of signs and symptoms of dry eye disease, as it is distinguished by a novel mechanism of action and release system for the eye. In a Phase II study carried out in the United States, Pro-Ocular™ has shown to significantly reduce or eliminate ocular discomfort, dryness, and grittiness. Utilizing the TearScan™ instrument, tear film secretion is observed within minutes in over 95% of subjects following Pro-Ocular™ application.
"Pro-Ocular™ has shown statistically significant improvements in treating symptoms of dry eye in early clinical results and may reinforce SIFI's leading position in the European dry eye market" said Maria Grazia Mazzone, Business & Portfolio Development Director at SIFI. "Our decision to invest in the development of this innovative therapy for the European market highlights our commitment to treating ophthalmic disorders which impact the health and quality of life of millions of people."
SIFI is the leading Italian ophthalmic company, focused on eye care since 1935. SIFI designs, manufactures and markets innovative pharmaceutical specialty products, surgical and medical devices. Headquartered in Catania, Sicily, SIFI operates directly in Italy, Romania and Mexico with a staff of more than 370 people worldwide. Since June 2015, SIFI is backed by 21 Investimenti, a private equity firm founded by Alessandro Benetton, which supports the company’s international expansion and portfolio development strategy. More information available at www.sifigroup.com.
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GLIA, LLC, a pharmaceutical development company based in Boston, USA, is developing small molecule products based on novel dermal non‐invasive topical drug delivery that can provide rapid chemical neural signaling to the brain. Glia’s most advanced product candidate is a treatment for dry eye disease, with a novel mechanism of action for creating a rapid and durable endogenous tear film on the ocular surface.
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1. TFOS DEWSII Report, http://www.tfosdewsreport.org/index.php?lng=en