- Thinly traded micro cap Kala Pharmaceuticals (Pending:KALA) slumps 16% premarket on average volume on the heels of its announcement of results from two Phase 3 clinical trials, STRIDE 1 and STRIDE 2, evaluating lead candidate KPI-121 (loteprednol etabonate) in patients with dry eye disease.
- STRIDE 1 achieved its primary sign endpoint of the change in conjunctival hyperemia from baseline to day 15 (p<0.0001) and the primary symptom endpoint of the severity of ocular discomfort from baseline to day 15 (p<0.0001), but missed a secondary endpoint, the change in inferior corneal staining from baseline to day 15 (p=0.1128).
- STRIDE 2 met the primary sign endpoint, but missed the primary symptom endpoint (p=0.1298) and missed the secondary ocular discomfort endpoint (p=0.0799).
- On the safety front, the most common adverse event in STRIDE 1 was instillation site pain (6.1% in both treatment and placebo groups). The only other adverse event occurring in more than 1% of patients was eye irritation (1.1% in the KPI-121 cohort versus 1.5% for placebo).
- In STRIDE 2, the incidence of instillation pain was 5.7% in the treatment group compared to 4.4% for placebo. Blurred vision was reported in 0.2% of the patients in the KPI-121 group versus 1.3% for placebo. Elevations in intraocular pressure (IOP), a known side effect from topical corticosteroid use, were similar between the two groups. 1.1% of the KPI-121 cohort experienced an increase in IOP of at least 5 mmHg which resulted in an IOP of at least 21 mmHg (normal range: 12 - 22 mmHg).
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