EyeGate Pharmaceuticals’ corticosteroid treatment for noninfectious anterior uveitis—delivered directly into the ocular tissue via the company’s device and a low-level electric current—failed to perform as well as prednisolone eyedrops, missing its endpoint in a phase 3 clinical trial.
The Waltham, Massachusetts-based company’s EGP-437 (dexamethasone phosphate) and iontophoresis delivery system showed some clinical efficacy but did not demonstrate noninferiority in decreasing inflammation after two weeks when compared to the control group, the company said in a statement.
Anterior uveitis is caused by inflammation of the middle layer of the eye, including the iris and adjacent tissues, when the body triggers an immune response without a present infection. Without emergency treatment, complications can include glaucoma, cataracts or retinal edema resulting in permanent vision damage. The randomized trial, completed earlier this year, had enrolled 251 participants.
EyeGate’s delivery device applies an electric current to the drug to increase its ability to cross biological membranes and propel it across the white of the eye. The company believes its quick, in-office method can deliver higher concentrations of a drug compared to traditional topical routes, such as eyedrops, with longer treatment effects and far fewer doses.
The news sent the company’s stock down at least 15%. EyeGate had originally planned to file a new drug application with the FDA in the first half of this year—following a 2015 deal that granted a Valeant Pharmaceuticals subsidiary exclusive worldwide commercialization rights, and would have netted EyeGate milestone payments upon approval.
“Although we are disappointed with the results of the uveitis study we continue to review the data and assess the path forward for EGP-437,” EyeGate President and CEO Stephen From said in a statement. From said the company may now shift its focus to ongoing clinical trials of a topically applied ocular bandage gel for patients with damaged corneas.
Currently available as a veterinary device—manufactured by SentrX Animal Care and sold by Bayer Animal Health as Remend Corneal Repair for dogs, cats and horses—EyeGate’s investigational ocular bandage was obtained through its 2016 acquisition of Jade Therapeutics. The hydrogel-based technology forms a barrier that helps hydrate the corneal surface as it heals.
The company recently began enrolling up to 45 participants in a pilot study incorporating the bandage in recovery following photorefractive keratectomy eye surgery, or PRK, an alternative to LASIK procedures. The corneal wounds created while performing PRK form an excellent model for other epithelial defects, EyeGate said, as patients undergo removals of the outer layer of the cornea before the refractive laser surgery.
That study, as well as a randomized study of the bandage in surface damage related to dry eye and other pathologies, are both on tract to produce top-line data before the end of the year, From said.