Trials Show KPI-121 Ophthalmic Suspension Improves Ocular Comfort

Multiple phase 3 trials found that KPI-121 ophthalmic suspension 0.25% was safe and efficacious for the treatment of dry eye disease, according to research presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting held July 23 to 27, 2021, in Las Vegas.

KPI-121 ophthalmic suspension 0.25% is a loteprednol etabonate nanoparticle suspension with mucus-penetrating particle proprietary technology.

Patients (N=2721) with dry eye disease were recruited for 3 phase 3 clinical trials, known as the Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease (STRIDE 1, cliicaltrials.gov identifier NCT02813265 STRIDE 2, NCT02819284, and STRIDE 3, NCT03616899 ). Randomization occurred at a 1:1 ratio to receive KPI-121 0.25% (n=1360) or the drug vehicle (n=1362) QID for 2 weeks after a 2-week run-in period with the drug vehicle. Patients were assessed for ocular discomfort severity, conjunctival hyperemia, safety, and tolerability.

At day 15, patients in the treatment group reported significantly improved ocular discomfort severity in the STRIDE 1 (P <.0001) and STRIDE 3 (P =.0002) trials but not in the STRIDE 2 trial (P =.1298). Improved ocular discomfort was first observed on day 8 of KPI-121 0.25% therapy during all 3 trials (all P ≤.0408).

The patients in all trials reported significant improvements in conjunctival hyperemia by day 15 of active therapy (all P <.0001).

The most frequently reported adverse event was instillation site pain and rates were similar among the active treatment recipients (4.9%) and the vehicle recipients (4.0%). No significant difference in the rate of intraocular pressure was observed.

These studies may have been limited by the short treatment duration, it remains unclear whether improvements to ocular discomfort or conjunctival hyperemia remain consistent with long-term use.

These data indicated KPI-121 ophthalmic suspension 0.25% improved ocular discomfort and conjunctival hyperemia among patients with dry eye disease. The drug was safe and well-tolerated during a 2-week QID treatment regimen.

Disclosure: Multiple authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please refer to the original article for a full list of disclosures.

Reference

Holland EJ, Kim T, Nichols KK, et al. Safety and efficacy of kpi-121 ophthalmic suspension 0.25% for dry eye disease in three phase three randomized controlled trials. Presented at: 2021 ASCRS Annual Meeting; July 23-27, 2021; Las Vegas, NV. Poster 78374.