EyeGate’s steroid implant edges past placebo, falls short of significance

An experimental treatment for pain and inflammation, EGP-437 (iontophoretically delivered dexamethasone), showed slight but consistent benefits in a phase 2b trial of cataract surgery patients.

The drug performed about as well as other anti-inflammatory products, according to EyeGate Pharmaceuticals, but its benefits failed to reach statistical significance because the placebo group fared unexpectedly well after cataract removal.

“The efficacy results for the absence of inflammatory cells in the EGP-437 treatment group met our expectations, but the vehicle group response was better than anticipated,” Randall Olson, MD, EyeGate’s strategic advisor, said in a company press release.

The EyeGate II Delivery System offers an alternative to postoperative eye drops. The system uses an electrical field to drive an iontophoretic glucocorticoseroid through the sclera. This delivers a more concentrated dose than traditional topical applications, thereby increasing bioavailability and sustaining the therapeutic effects with less volume.

The trial compared pain scores and anterior chamber cell counts in 106 participants at various timepoints after cataract surgery. At each time point—most strikingly beyond day 14—patients treated with EGP-437 were more likely than controls to report zero pain and lack inflammatory cells.

The company plans to forge ahead with the treatment despite the disappointing results.

“We will continue to review the data to determine next steps and to continue evaluating EGP-437 for the reduction of pain and inflammation following ocular surgery,” stated Barbara Wirostko, MD, EyeGate’s chief medical officer.