EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG), today announced completion of patient enrollment for the pivotal Phase 3 clinical study of its EGP-437 combination product for the treatment of non-infectious anterior uveitis. 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.
Under this agreement, EyeGate is eligible to receive developmental and sales-based milestones totaling up to approximately $99.0 million, as well as royalties on Valeant’s net sales of the product. Completion of patient enrollment has triggered a milestone payment from Valeant under this licensing agreement.
EyeGate and Valeant are also studying EGP-437 for treatment of post-operative ocular inflammation and pain in ocular surgery. EyeGate received a milestone payment from Valeant in May of 2017 related to development for this indication.
EGP-437 is dexamethasone delivered via EyeGate's transscleral iontophoresis delivery system The system utilizes a low-level electrical current to deliver a specified amount of drug for each treatment. . Ph II results in a study for pain and inflammation in patients having undergone cataract surgery announced in February of 2018 did not show statistically significant superiority over the control group. However EGP-437 was numerically superior and the control group's results were better than historical norms.