OTX-101 significantly improves severely impaired tear production
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Patients with severe tear deficiency due to keratoconjunctivitis sicca experienced significant improvements after treatment with OTX-101 0.09% compared with vehicle, according to data published in Current Eye Research.
Melissa Toyos, MD, FACS, and colleagues investigated the effects of OTX-101 0.09% (Sun Pharmaceutical Industries) vs. vehicle in patients with severely impaired tear production, defined by a Schirmer’s score of less than 5 mm in either eye at baseline. These patients were then compared with a subgroup from an intent-to-treat population.
Data were derived from a phase 2b/3 study and a phase 3 study. Both studies had a 14- to 20-day run-in period, during which patients received one drop of vehicle per eye twice daily. They were randomly assigned 1:1 during the treatment period to either OTX-101 or vehicle, one drop per eye twice daily for 84 days.
“Both phase 2b/3 and phase 3 clinical trials demonstrated that OTX-101 0.09% was superior to vehicle in improving tear production in patients with [keratoconjunctivitis sicca] and was well tolerated. This pooled analysis evaluated the effect of OTX-101 0.09% vs. vehicle on tear production in patients with severe tear deficiency and compared the results from this subgroup with those from an intent-to-treat population,” Toyos and colleagues wrote.
In the subgroup population, 133 patients (mean age, 58.9 years; 85.7% women; 81.2% white; mean baseline Schirmer’s score, 2.7 mm) received OTX-101, while 113 patients (mean age, 62.5 years; 84.1% women; 82.3% white; mean baseline Schirmer’s score, 2.5 mm) received vehicle.
The primary outcome was an increase in Schirmer’s score of more than 10 mm at day 84 or early discontinuation relative to baseline.
On day 84, 22.6% of patients in the OTX-101 group had a change in Schirmer’s score of 10 mm or higher compared with baseline vs. 10.6% in the vehicle group (P = .0168). In the OTX-101 group, the mean change was 5.5 ± 8 mm compared with 3.6 ± 6 mm in the vehicle group (P = .0405). Adverse events were mostly mild.
Limitations of the study include a short treatment duration and lack of long-term follow-up.
“OTX-101 may significantly improve tear production in patients with [keratoconjunctivitis sicca], including those with severe aqueous deficient dry eye (with a baseline Schirmer’s score < 5 mm). The combined efficacy and safety profile of OTX-101 0.09% appears to offer clinical benefits for patients with severe [keratoconjunctivitis sicca],” the study authors wrote.
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