STRIDE 3 phase III trial of Eysuvis meets endpoints in dry eye disease.- Kala Pharma

Kala Pharmaceuticals announced positive topline results from STRIDE 3, a Phase III clinical trial evaluating KPI 121 0.25%, which Kala plans to commercialize under the brand name Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25%, for the treatment of dry eye disease. STRIDE 3 met both of its primary efficacy endpoints, demonstrating a statistically significant improvement in the symptom endpoint of ocular discomfort severity (ODS) at day 15 in the overall intent-to-treat (ITT) population (p=0.0002) and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline (p=0.0007). Statistical significance was also achieved in the key secondary endpoints of conjunctival hyperemia at day 15 in the ITT population (p<0.0001) and ods at day 8 in the itt population (p="0.0282)." significant results were also observed for total corneal staining at day 15 in the itt population (p="0.0042)." eysuvis was well tolerated, with adverse events and intraocular pressure increases comparable to vehicle. the most common adverse event observed in stride 3 was instillation site pain, which was reported by 2.9% in the eysuvis group compared to 1.5% in the vehicle group. elevations in intraocular pressure (iop), a known side effect with topical corticosteroid administration, were similar between the two groups, with no patients in either the eysuvis or vehicle group experiencing an increase in iop of 5 mmhg or greater that resulted in an iop of greater than 21 mmhg in the study eye. comment: kala plans to utilize these data as the basis for a class 2 resubmission of the new drug application (nda) for eysuvis in the second quarter of 2020, with an expected six-month review timeline by the fda.>