Ophthalmalogical-focused developer EyeGate Pharma said this week that the Phase 3 study of its EGP-437 delivered through its EyeGate II drug delivery system did not show non-inferiority to the prednisolone acetate ophthalmic solution control group.
The Phase 3 study was evaluating the safety and efficacy of the EGP-437 with the EyeGate II in patients with non-infectious anterior segment uveitis, the Waltham, Mass.-based company said.
Data from the trial indicated that EGP-437 showed clinical efficacy as defined by a reduction in anterior chamber cell scores throughout the study, and that it’ll 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. This also represents an opportunity to shift our focus toward the key clinical trials that support our innovative Ocular Bandage Gel product, which has the potential to benefit patients with corneal surface damage. We are actively enrolling for the PRK and PE studies, both of which are on track for announcement of top-line data in the fourth quarter of 2018. We continue to consider all strategic alternatives to maximize shareholder value,” prez & CEO Stephen From said in a press release.