OTX-CSI improves dry eye signs, symptoms in phase 1 study
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OTX-CSI seems to be a safe treatment option for patients with dry eye disease, according to a speaker at the European Society of Cataract and Refractive Surgeons meeting.
“The OTX-CSI intracanalicular insert with cyclosporine improved signs and symptoms of dry eye disease as measured by change from baseline in Schirmer’s test, corneal staining, dry eye disease severity and frequency scores, and dry eye disease symptom questionnaires,” Mitchell A. Jackson, MD, said.
The phase 1 study investigating OTX-CSI (Ocular Therapeutix) included five patients who had dry eye disease in both eyes for 6 or more months, a dry eye severity score of 30 or more in the study eye, total corneal staining score between 6 and 14, and Schirmer’s score between 1 mm and 10 mm at 5 minutes. Study endpoints included safety, Schirmer’s score at 12 weeks, eye dryness score severity and frequency, total corneal fluorescein staining and Ocular Surface Disease Index score.
There were no serious adverse events or treatment-related adverse events reported. There was also no stinging, burning or dysgeusia reported, Jackson said.
Patients reported an improvement in Schirmer’s score from 4.2 mm at baseline to 8.5 mm at 16 weeks, as well as an improvement in total corneal fluorescein staining from 6.7 at baseline to 4.3 at 16 weeks.
Eye dryness severity score improved from 51 at baseline to 23.4 at week 16, and eye dryness frequency score improved from 50.6 at baseline to 27.8 at week 16, Jackson said.
A randomized, vehicle-controlled phase 2 study investigating the therapy for dry eye disease is underway.
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Jackson M, et al. Phase 1 trial evaluating the safety, tolerability and efficacy of a sustained-release cyclosporine intracanalicular insert for the treatment of dry eye disease. Presented at: European Society of Cataract and Refractive Surgeons meeting; Oct. 8-11, 2021; Amsterdam.
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