It’s a very rewarding trading day for investors in Eyegate Pharmaceuticals (NASDAQ:EYEG) with shares up over 35%, making the stock Wall Street’s bull of the day. Why the excitement? The clinical-stage company announced this morning completion of patient enrollment in the pivotal Phase 3 clinical study of its EGP-437 combination product for the treatment of non-infectious anterior uveitis. The completion has triggered a milestone payment from Valeant under their 2015 agreement.
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.”
Recently, EyeGate announced that the company had resubmitted an amended Investigational Device Exemption (IDE) application to the FDA for a pilot study of the ocular bandage gel (OBG) based on the cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) technology. OBG is a non-partnered candidate within EyeGate’s pipeline and is currently being developed for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK). The amendment includes validation data on the manufacturing processes and bioburden tests related to production of OBG, as well as data related to the analytical methods to identify and quantify impurities and degradation products.
Two analysts have issued ratings on EYEG in the past 12 months: H.C. Wainwright’s Ram Selvaraju reiterated a Buy rating on the stock, with a $3.00 price target, while Noble Financial analyst Caroline Palomeque maintained a Buy rating without providing a target.