EyeGate Pharmaceuticals announced that the first patient was enrolled in the company’s phase 2b clinical trial of its EGP-437 combination product. The EyeGate II Delivery System and EGP-437 combination product is being evaluated for the treatment of pain and inflammation in patients having undergone cataract surgery with implantation of a monofocal posterior chamber IOL.
As announced in the first quarter of 2017, EyeGate and Valeant Pharmaceuticals International entered into an exclusive, worldwide licensing agreement through which EyeGate has granted a subsidiary of Valeant exclusive, worldwide commercial and manufacturing rights to the EGP-437 combination product candidate for the treatment of postoperative ocular inflammation and pain in ocular surgery patients. Valeant expects to commercialize the combination product, once approved, through its Bausch + Lomb Pharmaceuticals business.
“Enrollment of the first patient in our phase 2b cataract surgery trial represents an important milestone for EyeGate and our novel, physician-administered iontophoretic treatment," Stephen From, President and CEO of EyeGate, said in a company news release. "This trial will allow us to better understand the clinical benefit patients are receiving from this therapy, and to support its role in the management of pain and inflammation, common side effects following cataract surgery. We are thrilled to have taken this significant step toward advancing the development of the EGP-437 combination product in this significant ophthalmic market.”
Jeffrey Levenson, MD, of Levenson Eye Associates in Jacksonville, FL, an investigator of the trial added, “We are hopeful that this treatment option will prove beneficial for patients that have previously undergone cataract surgery. The effective management of postoperative pain and inflammation is currently daily topical steroids for cataract surgery patients, and this study represents an opportunity to bring a potentially more attractive therapeutic option to patients in need.”
The phase 2b trial, a double-masked, randomized, placebo-controlled trial, intends to enroll up to 100 subjects. The trial will be conducted at up to 8 sites in the United States and is designed to evaluate the safety and efficacy of transcleral iontophoretically-delivered EGP-437, a novel formulation of dexamethasone phosphate ophthalmic solution, through the Company’s EyeGate II Delivery System, in patients having undergone cataract surgery with implantation of a monofocal posterior chamber IOL. The primary efficacy endpoint is the proportion of subjects with an anterior chamber (AC) cell count of zero at day 7 and the proportion of subjects with pain score of zero at day 1.