Why carry out this study?

Noninfectious keratitis is a painful inflammation of the cornea that is associated with considerable morbidity and severe complications, including loss of vision.

Keratitis can be treated with topical lubricants, cyclosporine, lifitegrast, corticosteroids, and immunosuppressants; however, alternative treatments are needed for patients in whom these treatments are not effective.

We conducted a phase 4, multicenter, open-label study to assess the efficacy and safety of repository corticotropin injection (RCI; Acthar® Gel) in patients with refractory severe noninfectious keratitis that had not improved after treatment with standard therapies.

What was learned from this study?

After 12 weeks of treatment with RCI, 50.0% of patients experienced clinically important improvements in the symptom bother domain of the Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire; improvements were also observed in the following assessments: IDEEL Questionnaire, Ocular Discomfort and 4-Symptom Questionnaire, Visual Analog Scale, corneal fluorescein staining, conjunctival lissamine green staining, Conjunctival Redness Scale, and tear production (Schirmer’s test). Adverse events (AEs) were mild, with blurry vision and double vision being the only ocular AEs reported.

Results of this study showed RCI to be a safe and effective treatment for refractory severe noninfectious keratitis.