Kala’s Dry Eye Candidate Meets Both Sign Endpoints, Misses One Symptom Endpoint in Phase III Studies

January 5, 2018: By Market Scope

Kala PharmaceuticalsKala Pharmaceuticals announced Jan. 5 that KPI-121 0.25% saw mixed results in its two Phase III clinical trials in dry eye disease, meeting three or four primary endpoints.

Kala CEO Mark Iwicki said the company would need to study the data more to decide the path forward, and he was unable to provide a timetable.

The company said it plans to seek a meeting with US regulators for guidance. Future options include conducting another study or submitting the data as is to the FDA.

The Waltham, Massachusetts, firm said it believes its cash balance of $114 million puts it in a strong position as it continues to advance its candidates.

Kala’s formulations use its mucus-penetrating particle (MPP) technology to enhance penetration of the steroid loteprednol etabonate in eye tissue.

Kala’s lead candidates are KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease; and INVELTYS (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery.

The dry eye candidate achieved statistical significance in both Phase III trials (STRIDE 1 and STRIDE 2) in the primary sign endpoint of improvement in conjunctival hyperemia at Day 15.

It showed statistical significance in the primary symptom endpoint of improvement in ocular discomfort at Day 15 in the first Phase III trial. In the second trial, it showed improvement, but not at a statistically significant level.

The trials were multicenter, randomized, double-masked, placebo-controlled studies comparing KPI-121 with placebo, each dosed four times a day for 14 days.

In both studies, KPI-121 0.25% was well-tolerated, with elevations of intraocular pressure similar to placebo.

Kala also announced Jan. 5 that the FDA had accepted INVELTYS’ submission for review and assigned a target action date of Aug. 24.

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