EyeGate Pharmaceuticals announced topline results from its phase 3 study evaluating the safety and efficacy of EGP-437 delivered through the EyeGate II Drug Delivery System (EGDS) in patients with non-infectious anterior segment uveitis.
Although EGP-437 showed clinical efficacy, defined as a reduction in anterior chamber cell score throughout the study, it did not demonstrate non-inferiority to the prednisolone acetate ophthalmic solution control group. This was measured as the proportion of subjects with an anterior cell count of zero (a sign of diminished inflammation) at day 14. EyeGate will continue to review the data and will be assessing its strategic options for EGP-437 going forward.
“Although we are disappointed with the results of the Uveitis study we continue to review the data and assess the path forward for EGP-437,” Stephen From, President and Chief Executive Officer of EyeGate, said in a company news release. “This also represents an opportunity to shift our focus toward the key clinical trials that support our innovative Ocular Bandage Gel (OBG) product, which has the potential to benefit patients with corneal surface damage. We are actively enrolling for the PRK (photorefractive keratectomy) and PE (punctate epitheliopathy) studies, both of which are on track for announcement of topline data in the fourth quarter of 2018. We continue to consider all strategic alternatives to maximize shareholder value.”