First Clinical Trial Evaluating EyeGate(R) II Delivery System in Posterior of Eye
WALTHAM, Mass., July 14, 2015 (GLOBE NEWSWIRE) — Eyegate Pharmaceuticals, Inc. (EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced the dosing of the first patient in its Phase 1b / 2a trial (NCT02485249) of lead product candidate EGP-437 in Macular Edema (“ME”).
The open-label, multi-center study is designed to evaluate the efficacy and safety of EGP-437, a novel formulation of dexamethasone phosphate ophthalmic solution delivered iontophoretically using the Company’s proprietary EyeGate(R) II Drug Delivery System. The trial, which will include up to five clinical sites in the U.S., aims to enroll up to 20 patients diagnosed with Retinal Vein Occlusion, Diabetic Macular Edema or Cystoid (post-surgical) macular edema. In addition to the ME trial, the Company is developing EGP-437 for non-infectious anterior uveitis.
“The treatment of our first patient in the Macular Edema trial is a significant step in clinical development of EGP-437 and the EyeGate(R) II Delivery System as we explore the products’ application beyond our initial target indication of anterior uveitis. This trial is the first to utilize the EyeGate(R) II Delivery System for administration of drug to the back of the eye, and we are excited to explore the capabilities of our proprietary technology for back-of-the-eye indications,” said Stephen From, President and Chief Executive Officer of EyeGate. “We believe that EGP-437 represents a potential game changer in the treatment of macular edema, and may provide a viable non-invasive alternative to the current standard of care. We look forward to evaluating the potential of EGP-437 to improve, and in some cases save, the vision of ME patients.”
Richard Chace M.D., Eyesight Ophthalmic Services and an investigator of the trial added, “The EyeGate(R) II Delivery System has the potential to change the way in which ocular drugs are administered, particularly those previously only available via injection. The first patient enrolled in the trial had previously undergone extensive treatment, including over a dozen intravitreal injections, and noted that the difference between iontophoresis and injection was remarkable. We look forward to following up with this patient as we assess the safety and efficacy of EGP-437 in ME, which could lead to the product’s evaluation in other posterior indications.”
EyeGate is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye. EGP-437, the Company’s first and only 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(R) II Delivery System. For more information, please visit www.EyeGatePharma.com.
Safe Harbor Statement:
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 EGP-437, 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, certain risk factors described under the heading “Risk Factors” contained in our Annual Report on Form 10-K filed with the SEC on March 31, 2015, 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.