This site is intended for healthcare professionals
News

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

Read time: 1 mins
Published:10th Mar 2020
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.>
Condition: Dry Eye Syndrome
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.