Kala Pharmaceuticals provided an update on the development plan for KPI-121 0.25%, which if approved could be the first FDA-approved product for the short-term treatment of dry eye disease.
The company announced that it plans to submit a new drug application (NDA) to the FDA during the second half of 2018. The NDA will include data from three clinical trials studying approximately 2000 patients, including one phase 2 trial and two phase 3 efficacy and safety trials.
In addition, based upon the recommendation of the FDA, Kala plans to initiate an additional phase 3 clinical trial evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The company plans to initiate the new trial, STRIDE 3 (STRIDE – Short Term Relief In Dry Eye), in the third quarter of 2018. Topline results for STRIDE 3 are anticipated in the fourth quarter of 2019.
The company has conducted a comprehensive analysis of data generated in its previous three clinical trials and believes it has identified key factors that contributed to the differences observed in the results from STRIDE 2 compared to those of STRIDE 1 and phase 2. The company has integrated these factors into the trial design of STRIDE 3, which the company believes will improve the probability of success for the trial.
Kala remains committed to developing KPI-121 0.25% for the millions of patients suffering from dry eye disease for whom there is currently no product approved for the temporary relief of signs and symptoms of the disease.
Kala also continues to prepare for the potential approval and launch of INVELTYS, which, if approved, is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of postoperative ocular inflammation and pain. The FDA accepted the INVELTYS NDA for review in January 2018 and provided a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018. The brand name for KPI-121 1%, INVELTYS, has been conditionally approved by the FDA.