In its Stride 1 trial, the company’s drug met statistical significance for the primary endpoint of conjuctival hyperemia change from baseline to day 15, as well as the primary endpoint of ocular discomfort severity change from baseline to day 15. However, the product did not meet its inferior corneal staining change endpoint.
In the Stride 2 trial, while KPI-121 met the primary endpoint of conjunctival hyperemia change from baseline to day 15, it failed to meet the ocular discomfort severity change endpoint.
“We are pleased with the positive topline results of Stride 1, in which KPI-121 demonstrated statistically significant improvements in primary sign and symptom endpoints and are encouraged with the results in Stride 2, which showed statistical significance for the primary sign endpoint. Although we did not achieve statistical significance for the primary symptom endpoint in Stride 2, we did observe a strong trend towards a positive treatment effect in symptoms in more symptomatic patients, for which we achieved statistical significance in Stride 1,” CEO Mark Iwicki said in prepared remarks.
“We will continue to analyze the results of both Phase III trials and the totality of the data from all 3 trials conducted to date and expect to discuss our clinical program with the FDA. We believe that our preliminary, unaudited December 31, 2017 cash balance of approximately $114 million puts us in a strong position as we maintain our focus on moving this program forward to serve patients with dry eye disease.”
Also today, Kala reported that the FDA accepted its new drug application for Inveltys, a 1% formulation of KPI-121. If approved, the drug would be the first twice-daily ocular steroid designed to treat inflammation and pain following ocular surgery, according to Kala.
The FDA is expected to make a decision about the drug by Aug. 24.
KALA shares were trading at $12.47 in mid-afternoon activity today, down -28%.