Non-infectious anterior uveitis is characterized by the inflammation of the anterior chamber of the eye. Symptoms may include redness, soreness and inflammation of the eye, blurring of vision, sensitivity to light and a small pupil. If untreated anterior uveitis can cause permanent damage and vision loss.
The double-masked, randomized, positive-controlled trial enrolled 250 patients in the United States. The trial was designed to assess the safety and efficacy of iontophoretically-delivered EGP-437 in patients with unilateral or bilateral non-infectious anterior segment uveitis.
The primary efficacy endpoint of the trial was the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14. Subjects were provided three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment. Patients enrolled in the EGP-437 arm were provided placebo eye drops, while patients receiving placebo iontophoresis treatment are given prednisolone acetate (1%) drops. Eye drops for both arms were administered for a period of up to 28 days and for up to 8 drops per day.
“Completion of patient enrollment in this confirmatory Phase 3 clinical trial evaluating our unique EGP-437 combination product represents a major milestone for the company,” commented Stephen From, President and Chief Executive Officer of EyeGate. “Congratulations to our committed team of trial investigators and coordinators on this critical milestone. We expect top line data in the third quarter and, assuming positive data from this trial, we plan to submit a New Drug Application to the FDA in the first half of 2019.”
In 2015, EyeGate and a subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE:VRX) and (TSX:VRX) entered into an exclusive, worldwide licensing agreement, through which EyeGate granted Valeant worldwide commercial and manufacturing rights, as part of its Bausch + Lomb business, to its EyeGate® II Delivery System and EGP-437 combination product in the field of uveitis. Completion of patient enrollment has triggered a milestone payment from Valeant under this licensing agreement.
EyeGate is a clinical-stage specialty pharmaceutical company focused on developing and commercializing products using its two proprietary platform technologies for treating diseases and disorders of the eye.
EyeGate’s CMHA-S platform is based on a cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form of the natural polymer hyaluronic acid (“HA”), which is an eye drop that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. 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.
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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 Therapeutics, Inc., 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, certain risk factors described under the heading “Risk Factors” contained in EyeGate’s Annual Report on Form 10-K filed with the SEC on March 02, 2018 or described in EyeGate’s other public filings. EyeGate’s results may also be affected by factors of which EyeGate is 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.