SIFI Initiates Patient Enrollment in Phase 2 Trial Evaluating Pro-Ocular in Dry Eye Disease
SIFI announced the enrollment of the first patients in the ProGIFT trial, which aims to evaluate 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 2 clinical trial comparing different concentrations of Pro-ocular (1% and 0.5%) versus placebo. The trial involves four ophthalmic centers in Italy specialized on disorders of the ocular surface and is expected to recruit 105 participants.
Previous U.S. phase 2 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,” Dr. Sebastiano Giuffrida, Head of Clinical Development at SIFI, said in a company news release. “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
References
1. TFOS DEWSII Report, http://www.tfosdewsreport.org/index.php?lng=en