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Joseph Grieco, PhD, notes that treatment fills a gap for patients who are unresponsive to the standard treatments for noninfectious keratitis.
This treatment fills a gap for patients who are unresponsive and/or intolerant to the standard treatments for noninfectious keratitis, such as lubricants, corticosteroids, and immunosuppressants.
Few treatments are available for this patient population with advanced disease, according to Joseph Grieco, PhD, director of Clinical Development at Mallinckrodt Pharmaceuticals in Bedminster, New Jersey.
Grieco explained that RCI works via its anti-inflammatory and immunomodulatory effects through interaction with melanocortin receptors.1
Grieco and his colleagues conducted a multicenter, open-label, phase 4 study to evaluate the efficacy and safety of RCI in patients with refractory severe non-infectious keratitis.
The primary efficacy endpoint was the proportion of patients with improvements in the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire score by 12 or more points. The Visual Analogue Scale (VAS) for burning/stinging and eye discomfort, and corneal fluorescein staining were exploratory endpoints for the study.
The safety endpoints were the proportion of patients with treatment-emergent or serious adverse effects during the study.
The study included 36 patients (mean age, 63.3 years; 71.4% women; 80% Caucasian). All patients had bilateral keratitis (mean duration, 4.4 years). Patients administered 80 units of RCI twice a week for 12 weeks followed by tapering for 4 weeks.
Grieco explained that the IDEEL symptom bother score at week 12 after the start of treatment showed that 50% of patients had greater than a 12-point improvement, and 52.9% achieved that level of improvement as early as week 2 after treatment initiation.
“The mean changes from baseline in the symptom bother score exceeded the minimal clinically important difference threshold at every evaluation point,” he said.
At the 12-week evaluation, the VAS score indicated that all symptoms improved from baseline, with the most pronounced improvements seen in ocular dryness and discomfort.
Improvements in corneal and conjunctival staining also were seen as soon as 4 weeks after treatment started and were sustained through week 12.
The mean change went from 5.3 at baseline to -1.0 at week 4 and was sustained to week 12 at -1.1.
A third of patients had an adverse effect during the study, most of which occurred once. The intraocular pressure did not increase.
“The results of this open-label study showed that 80 units of RCI twice weekly for 12 weeks was associated with rapid and sustained improvements in the symptoms of persistent severe noninfectious keratitis that had previously not responded to standard-of-care therapies,” Grieco concluded.
Joseph Grieco, PhD
This article is adapted from Grieco’s presentation at the Association for Research in Vision and Ophthalmology’s 2021 virtual annual conference. He is an employee of Mallinckrodt Pharmaceuticals. RCI is approved by the FDA for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, including keratitis.
1. Huang YJ, Galen K, Zweifel B, et al. Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists. J Recept Signal Transduct Res 2020;2020:1–9.