Kala Pharma released mostly positive topline results from two Phase III clinical trials for KPI-121 in patients with dry eye disease.
Kala Pharmaceuticals released mostly positive topline results from two Phase III clinical trials for KPI-121 in patients with dry eye disease.
The two studies, STRIDE 1 and STRIDE 2, compared KPI-121 0.25% versus placebo. Three out of four primary endpoints were met.
In STRIDE 1, the study showed statistical significant for conjunctival hyperemia change from baseline to day 15, and the primary symptom endpoint of ocular discomfort severity change from baseline to day 15. A second primary symptom of ocular discomfort severity change from baseline to day 15 was also met, but not achieved for a second pre-specified primary sign endpoint, inferior corneal staining change from baseline to day 15.
In STRIDE 2, it hit the primary endpoint of conjunctival hyperemia change from baseline to day 15, but did not for the primary symptom endpoint of ocular discomfort severity change from baseline to day 15. But, a positive treatment effect was observed at day 8, which was a key secondary 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 significant for the primary sign endpoint,” said Mark Iwicki, Kala’s chief executive officer, in a statement. “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 I.”
He went on to say, “We will continue to analyze the results of both Phase III trials and the totality of the data from all three 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.”
Liana Moussatos, an analyst with Wedbush, told Reuters, “The question is will the FDA accept this or make them do another trial before approval?” Although the fourth endpoint raises the questions, Moussatos indicates the first trial data were “the best results” for dry eye that she had observed in a late-stage trial.
Reuters also notes that if KPI-121 were approved by the FDA, it would be the first treatment in the U.S. for rapid relief for acute, episodic dry eye flare-ups. Reuters wrote, “The drug would face no real competition as approved treatments for dry eye such as Allergan Plc‘s blockbuster Restasis and Shire Plc’s Xiidra are indicated for chronic patients with continuous symptoms of the disease, rather than flare-ups.”
Dry eye disease affects about 33 million people in the U.S. If the drug is approved, it could hit peak sales of $1.9 million in 2027.
Although there isn’t much in the results to really indicate the FDA might turn the drug down, investors were concerned, with shares dropping over 20 percent to about $14.
Kala’s Inveltys for inflammation and pain in patients after eye surgery is currently being reviewed by the FDA. A decision is expected by August 24.
