Kala Pharmaceuticals will continue with an ongoing phase 3 trial assessing the solution, and could resubmit its NDA in 2020.
The US Food and Drug Administration (FDA) submitted a Complete Response Letter (CRL) to Kala Pharmaceuticals in response to its New Drug Application (NDA) for investigative therapy KPI-121 0.25%.
The company is seeking an NDA which would indicate the therapy solution for the temporary treatment of dry eye disease signs and symptoms. In its CRL, the FDA informed Kala that efficacy data from an additional trial is necessary to support their NDA resubmission.
At the time of the CRL, Kala is still enrolling patients in the ongoing phase 3 Short Term Relief In Dry Eye (STRIDE) clinical trial. They now anticipate this trial data will support their response submission to the CRL. STRIDE 3 topline data could be available by the end of 2019, and an NDA resubmission could be completed during the first half of 2020.
Kala is currently working with the understanding the resubmission would endure a six-month review period under the PDUFA. At the previous recommendation of the FDA, STRIDE 3 was initiated in July 2018, with specific modifications made to its preceding trials’ inclusion and exclusion criteria for patients treated with KPI-121 0.25%.
The STRIDE 3 trial—a multicenter, randomized, double-blind, placebo-controlled, parallel-arm study comparing four-times-daily KPI-121 0.25% to placebo in 900 patients with dry eye disease—is observing the therapy for a two-week treatment period.
KPI-121’s benefit for dry eye disease—a chronic multifactorial condition which affects the tears and ocular surface—comes from its enhanced penetration and targeting of the loteprednol etabonate and, eventually eye tissue. Its broad mechanism of action, along with rapid signs and symptoms relief onset and favorable tolerability and safety, were evidenced in the previous STRIDE 1 and 2 trials.
Kim Brazzell, chief medical officer of Kala, said in a statement the company remains confident in the potential of KPI-121 0.25%, and its campaign to become the first product approved in the US for temporary dry eye disease sign and symptom relief.
“We look forward to reporting data from STRIDE 3 and resubmitting the NDA with the goal of obtaining approval and being able to offer KPI-121 0.25% to the millions of patients with dry eye disease,” Brazzell said in a statement.