Kala reports mixed results in phase 3 trials of KPI-121 for dry eye

Two phase 3 clinical trials of KPI-121 0.25% for dry eye disease showed mixed results, according to a press release from Kala Pharmaceuticals.

The STRIDE 1 trial showed statistical significance for its primary sign endpoint of conjunctival hyperemia change from baseline to day 15 and its primary symptom endpoint of ocular discomfort severity change from baseline to day 15, the release said.

Also in STRIDE 1, a secondary prespecified primary symptom endpoint of ocular discomfort severity change from baseline to day 15 was met, but a secondary prespecified primary sign endpoint of inferior corneal staining change from baseline to day 15 was not met.

The STRIDE 2 trial met its primary sign endpoint of hyperemia change from baseline to day 15, but did not meet its primary symptom endpoint of ocular discomfort severity change from baseline to day 15.

KPI-121 uses Kala’s mucus-penetrating particle technology to enhance penetration of loteprednol etabonate to target tissues of the eye.

“We will continue to analyze the results of both phase 3 trials and the totality of the data from all three trials conducted to date and expect to discuss our clinical program with the FDA,” Mark Iwicki, Kala’s CEO, said in the release.

Two phase 3 clinical trials of KPI-121 0.25% for dry eye disease showed mixed results, according to a press release from Kala Pharmaceuticals.

The STRIDE 1 trial showed statistical significance for its primary sign endpoint of conjunctival hyperemia change from baseline to day 15 and its primary symptom endpoint of ocular discomfort severity change from baseline to day 15, the release said.

Also in STRIDE 1, a secondary prespecified primary symptom endpoint of ocular discomfort severity change from baseline to day 15 was met, but a secondary prespecified primary sign endpoint of inferior corneal staining change from baseline to day 15 was not met.

The STRIDE 2 trial met its primary sign endpoint of hyperemia change from baseline to day 15, but did not meet its primary symptom endpoint of ocular discomfort severity change from baseline to day 15.

KPI-121 uses Kala’s mucus-penetrating particle technology to enhance penetration of loteprednol etabonate to target tissues of the eye.

“We will continue to analyze the results of both phase 3 trials and the totality of the data from all three trials conducted to date and expect to discuss our clinical program with the FDA,” Mark Iwicki, Kala’s CEO, said in the release.