Dive Brief:
- Kala Pharmaceuticals, Inc.'s shares fell by almost 30% on Friday on the news of mixed Phase 3 results from its dry eye drug, KPI-121 0.25%, a suspension of loteprednol etabonate.
- The studies, STRIDE-1 and STRIDE-2, both reached statistical significance for what it called a primary sign endpoint. However, while the primary symptom endpoints were statistically significant in STRIDE-1, there was only a trend towards a treatment effect in STRIDE-2.
- The Food and Drug Administration has accepted a new drug application for twice-daily Inveltys (KPI-121 1%) for inflammation and pain post-ocular surgery, with a FDA target action date of August 24, 2018.
Editor's Note: A previous version of this article incorrectly stated that neither study met its secondary endpoints. Positive treatment effects were observed for ocular discomfort severity in the ITT population at day eight, a key secondary endpoint in both studies.
Dive Insight:
The STRIDE (Short Term Relief In Dry Eye) studies haven't been quite the success that Kala hoped.
The STRIDE-1 study succeeded in a so-called primary sign endpoint – conjunctival hyperemia (red eye) – by day 15, and for the primary and secondary symptom endpoint of change in severity of eye discomfort by day 15 in all patients and in patients with more severe discomfort. The study didn't meet significance for inferior corneal staining change, or for ocular discomfort at day 8.
Results were even more mixed for STRIDE-2. While the study met one endpoint, it missed all of the others.
Still, the company plans to continue to move the compound towards the market.
"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 a statement. "We will continue to analyze the results of both Phase 3 trials and the totality of the data from all 3 trials conducted to date and expect to discuss our clinical program with the FDA."
Both KPI-121 0.25% and Inveltys (KPI-121 1%) are based on Kala ’s proprietary Mucus Penetrating Particle technology, designed to enhance drug penetration and distribution in ocular tissues.
The news for Inveltys, in development for twice-daily use in inflammation and pain post-ocular surgery, is rather more positive.
"The FDA’s acceptance of the NDA filing for Inveltys is another significant milestone for the company towards our mission of developing innovative treatments for ocular conditions using our MPP technology," said CMO Kim Brazzell.
One potential benefit of Inveltys over the current marketed steroids to treat post-ocular surgery inflammation is its twice-daily rather than four times daily dosing.