EyeGate Pharmaceuticals said today it has licensed its clinical-phase sole product candidate for uveitis, final-negotiation rights to license the treatment for other indications, and the drug’s delivery system to Valeant Pharmaceuticals.
The value of the agreement was not disclosed. EyeGate said it will receive from Valeant an upfront cash payment, milestone payments related to completing development of EGP-437 for anterior uveitis, and a milestone payment tied to receipt of product approval by the FDA.
EyeGate also said that under the agreement, it could potentially receive royalties based on net sales, as well as additional milestone payments tied to achieving cumulative sales milestones. The company will oversee development of EGP-437 in the U.S. for anterior uveitis, and shoulder associated costs. Valeant will hold rights to developing the drug outside the U.S., in return for funding all associated costs.
Eye care is one of Valeant’s therapeutic areas of interest, which also include dermatology, neurology, and consumer healthcare. In 2013, Valeant acquired Bausch + Lomb for $8.7 billion, combining it with its existing ophthalmology businesses.
The agreement gives Valeant exclusive, worldwide commercial and manufacturing rights to EGP-437 for uveitis as well as the EyeGate® II drug delivery system.
EGP-437 incorporates a reformulated corticosteroid, dexamethasone phosphate, which is delivered into ocular tissues through EyeGate II. The non-invasive drug delivery system—based on technology developed at the Bascom Palmer Eye Institute at the University of Miami—uses a low-level electrical current to deliver a specified amount of drug for each treatment.
In May, EyeGate said it was planning a Phase III trial comparing EGP-437 to standard of care, Prednisolone Acetate Ophthalmic Suspension (1%), in patients with noninfectious anterior segment uveitis. The trial’s endpoint will be noninferiority as evaluated based on the proportion of subjects with total anterior chamber cell clearing at day 14 of EGP-437 treatment versus standard of care. The trial is expected to enroll up to 250 patients at approximately 60 U.S. clinical sites.
EyeGate said it received positive FDA guidance allowing it to use data from the upcoming trial, as well as a completed Phase III trial of EGP-437 in anterior uveitis, to support a future NDA filing for the treatment.
The company is also planning a Phase I/II trial (NCT02485249) evaluating the safety and efficacy of EGP-437 delivered through EyeGate II in patients with macular edema, according to information posted June 26 on ClinicalTrials.gov.
“In the future, we plan to explore EGP-437’s potential use to treat a variety of other inflammatory conditions of the eye,” EyeGate states on its website, adding: “These plans include anterior as well as posterior indications.”
EyeGate raised $4.1 million, minus underwriting discounts and other estimated offering expenses, from an initial public offering completed on February 13 on the OTCQB Venture Marketplace.