NEI launches phase 1/2 study of drug to treat scleritis

The National Eye Institute has opened patient enrollment for its noninfectious, active anterior scleritis trial, according to a Xoma Corp. press release.

Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory and other diseases, according to the release.

The phase 1/2 study will be open-label and assess the safety and efficacy of gevokizumab in patients experiencing non-infectious active anterior scleritis, the release said.

The NEI is expected to enroll 10 patients with a scleral inflammatory grade of greater than or equal to 1+ in at least one eye using a standardized photographic scleritis grading system developed at NEI, according to the release.

All patients will receive 60 mg of gevokizumab dosed every 4 weeks for a 16-week period. Patients who respond will have the option to continue treatment for an additional 20 weeks. Responders will be defined as patients who experience a two-step reduction on a 5-point scale from 0 to 4 or reach grade 0 in scleral inflammation in the study eye. Secondary measurements will include changes in visual acuity, intraocular pressure and scleral grading, the release said.

This is Xoma's third indication in a program of three proof-of-concept studies for gevokizumab, according to the release.