Kala completes enrollment in STRIDE 3 trial

Kala Pharmaceuticals has completed enrollment in the STRIDE 3 trial for KPI-121 0.25%, a treatment for temporary dry eye relief, according to a press release.

The enrollment follows a previous new drug application rejection from the FDA, which said that efficacy data from an additional clinical trial would be needed to support the resubmission of KPI-121 0.25%. The drug, branded Eysuvis, uses Kala’s Ampplify mucus-penetrating particle drug delivery technology to enhance penetration of loteprednol etabonate into the eye.

The phase 3 multicenter, randomized, double-masked, placebo-controlled, parallel-arm study is designed to obtain additional data that reflects the changes in inclusion and exclusion criteria of previous trials. These specific modifications aim to improve the probability of success as well as NDA approval for Eysuvis.

Nine hundred patients with dry eye who meet inclusion and exclusion criteria will be dosed with vehicle during a 2-week run-in period. The patients who continue to meet the criteria will be randomly assigned to receive either vehicle or Eysuvis four times a day for 2 weeks.

“If approved, we believe Eysuvis could become the preferred prescription therapy for dry eye flares, which affect the vast majority of dry eye patients,” Kim Brazzell, Kala chief medical officer, said in the release.

Kala Pharmaceuticals has completed enrollment in the STRIDE 3 trial for KPI-121 0.25%, a treatment for temporary dry eye relief, according to a press release.

The enrollment follows a previous new drug application rejection from the FDA, which said that efficacy data from an additional clinical trial would be needed to support the resubmission of KPI-121 0.25%. The drug, branded Eysuvis, uses Kala’s Ampplify mucus-penetrating particle drug delivery technology to enhance penetration of loteprednol etabonate into the eye.

The phase 3 multicenter, randomized, double-masked, placebo-controlled, parallel-arm study is designed to obtain additional data that reflects the changes in inclusion and exclusion criteria of previous trials. These specific modifications aim to improve the probability of success as well as NDA approval for Eysuvis.

Nine hundred patients with dry eye who meet inclusion and exclusion criteria will be dosed with vehicle during a 2-week run-in period. The patients who continue to meet the criteria will be randomly assigned to receive either vehicle or Eysuvis four times a day for 2 weeks.

“If approved, we believe Eysuvis could become the preferred prescription therapy for dry eye flares, which affect the vast majority of dry eye patients,” Kim Brazzell, Kala chief medical officer, said in the release.