Kala Pharmaceuticals Inc. (NASDAQ: KALA) shares seemed to be the only ones making gains on Monday amid the market carnage. The firm said that it had positive topline results from its late-stage clinical trial for the treatment of dry eye disease.
Specifically, the topline results come from the Stride 3 Phase 3 clinical trial evaluating KPI-121, which Kala plans to commercialize under the brand name Eysuvis.
Stride 3 met both of its primary efficacy endpoints, demonstrating a statistically significant improvement in the symptom endpoint of ocular discomfort severity at day 15 in the overall intent-to-treat (ITT) population and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline.
Statistical significance was also achieved in the key secondary endpoints of conjunctival hyperemia at day 15 in the ITT population and ocular discomfort severity at day 8 in the ITT population. Significant results were also observed for total corneal staining at day 15 in the ITT population.
Kala plans to use these data as the basis for a Class 2 resubmission of the New Drug Application for Eysuvis in the second quarter of 2020, with an expected six-month review timeline by the FDA.
Dr. Edward Holland, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati, commented:
These data reinforce the potential of EYSUVIS to transform the treatment landscape for dry eye disease. Eysuvis would be the first prescription dry eye product developed specifically to address the acute treatment needs of patients with dry eye disease, including dry eye flares that are experienced by the vast majority of patients. If approved, I believe Eysuvis would become a first-line therapy for patients at all stages of dry eye disease.
Kala Pharmaceuticals traded up more than 9% early Monday at $6.89, in a 52-week range of $3.24 to $8.92. The consensus price target is $18.33.
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