SIFI Initiates Patient Enrollment in Phase II Trial evaluating Pro-ocular in Dry Eye Disease

SIFI Initiates Patient Enrollment in Phase II Trial evaluating Pro-ocular in Dry Eye Disease
ProGIFT is a 3 arms, multicenter, randomized, double-masked clinical trial in Italy.

Catania (Italy) - 27 April 2021 - SIFI announced today the enrollment of the first patients in the ProGIFT trial (NCT04645446), which aims at evaluating the safety and efficacy of Pro-ocular, a progesterone based topical gel in patients with Dry Eye Disease (DED). ProGIFT (NCT04645446) is a multicenter, randomized, double-masked, placebo-controlled Phase II clinical trial comparing different concentrations of Pro-ocular (1% and 0.5%) versus placebo. The trial involves 4 leading ophthalmic centers in Italy specialized on disorders of the ocular surface and is expected to recruit 105 participants.

Previous U.S. Phase II clinical studies indicate that Pro-ocular compared to placebo elicits an ocular response of the tear film production by a neural pathway, potentially eliminating or reducing eye discomfort and dryness, and foreign body sensation, with no serious adverse reactions.

Under an exclusive license from GLIA LLC (Boston, MA, USA), SIFI is developing the product for Europe, including Russia and Turkey.

"This is a key milestone in the clinical development of Pro-ocular in Europe, which may result in a valuable therapeutic solution for addressing the unmet needs of patients with DED”, states Dr Sebastiano Giuffrida, Head of Clinical Development at SIFI “The initiation of this study highlights SIFI’s commitment to developing an innovative drug for a highly prevalent ophthalmic disorder”.

“Pro-ocular represents a potential new treatment paradigm for dry eye patients. The current standard of care encompasses eyedrops only, either as lubricating tears or anti-inflammatory drugs. Applied as a gel formulation to the forehead and massaged into the skin, Pro-ocular can be expected to facilitate endogenous tear secretion and therefore improve ocular surface conditions and symptoms through a very novel mechanism of action", says Dott. Stefano Barabino, Head of the Ocular Surface and Dry Eye Center, Ospedale L. Sacco-University of Milan, Italy, Principal Investigator of the ProGIFT Study.

For further information on the ProGIFT trial: https://clinicaltrials.gov/ct2/show/NCT04645446

About dry eye disease (DED)

DED is one of the most frequent causes of patient visits to eye care practitioners. It 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 also growing among children and adolescents. 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. Besides, 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 tear film production.

About Pro-ocular

Pro-ocular is a low concentration progesterone gel formulation (1% or 0.5%) which, applied and massaged twice daily laterally to the forehead, activates a neural pathway that leads to the stimulation of lacrimal and meibomian gland functions.

Patients using Pro-ocular in placebo-controlled clinical trials experienced rapid, significant and durable improvement in signs and symptoms of ocular surface disease and improved quality of life.

Pro-ocular has also shown an analgesic effect on ocular pain in pre-clinical animal models.

About SIFI

SIFI is a leading international ophthalmic company headquartered in Italy, focusing on eye care since 1935. SIFI develops, manufactures, and markets innovative therapeutic solutions for patients with ophthalmic conditions. SIFI is fully committed through its R&D to improve the quality of life of patients, exporting treatments to more than 20 countries worldwide with a direct presence in Italy, Spain, France, Romania, Mexico and Turkey.

About GLIA

GLIA, LLC is a pharmaceutical development company with patented inventions and discoveries based on a novel neural drug delivery platform that directly accesses the brain through the brainstem. The most advanced product in development is Pro-ocular topical gel for forehead progesterone delivery to treat ocular surface diseases such as dry eye disease.

1. TFOS DEWSII Report, http://www.tfosdewsreport.org/index.php?lng=en

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