EyeGate Pharmaceuticals announced the FDA has approved two of EyeGate’s investigational device exemption (IDE) applications for pilot studies of the company’s Ocular Bandage Gel (OBG) product for the acceleration of reepithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK), as well as the reduction in corneal staining for patients with punctate epitheliopathies (PE). EyeGate anticipates entering the clinic for both indications in the third quarter of 2018.
“Receiving FDA approval for both pilot studies is a significant milestone in the development of our EyeGate OBG platform,” Stephen From, EyeGate’s Chief Executive Officer, said in a company news release. “EyeGate is very pleased to have received these approvals and we look forward to getting these studies underway, as we expect to initiate the clinical trials in the third quarter.”
The PRK pilot study will enroll up to 45 subjects undergoing a bilateral procedure in a reading center masked trial. The trial intends to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. The primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3.
The PE study will enroll 30 patients in a two arm, 6-week trial with 15 patients per arm. PE is being defined in this trial by fluorescein staining of the cornea using the NEI scale. The primary performance outcome will be the change in NEI corneal staining score from day 0 to day 28 between the OBG arm and the comparator arm.