EyeGate Pharma Enrolls First Patient in Phase 2b Clinical Study of EGP-437 for Cataract Surgery
Top-line data anticipated by year-end 2017
WALTHAM, Mass., Aug. 01, 2017 (GLOBE NEWSWIRE) -- EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and disorders of the eye, today 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 (intraocular lens). As announced in the first quarter of 2017, EyeGate and Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX) (“Valeant”) 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 post-operative 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," said Stephen From, President and CEO of EyeGate. "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, M.D., 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.
About EyeGate:
EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. EyeGate is developing products using CMHA-S, a modified form of the natural polymer hyaluronic acid (HA), which possesses unique physical and chemical properties such as hydration and healing properties. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries.
EGP-437, EyeGate’s other product in clinical trials, incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate that is delivered into the ocular tissues through EyeGate’s proprietary innovative drug delivery system, the EyeGate II Delivery System. For more information, please visit www.EyeGatePharma.com.
Forward-looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements include statements relating to, among other things, the commercialization efforts and other regulatory or marketing approval efforts pertaining to EyeGate’s products, including EyeGate’s EGP-437 combination product and those of Jade, a wholly owned subsidiary of EyeGate, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, that the offering is subject to closing conditions that may not be met, plus other risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on February 23, 2017 or described in our other public filings. Our results may also be affected by factors of which we are not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. EyeGate expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Contact: Lee Roth / Janhavi Mohite The Ruth Group for EyeGate Pharmaceuticals 646-536-7012 / 7026 lroth@theruthgroup.com / jmohite@theruthgroup.com
Released August 1, 2017