Kala Pharmaceuticals touted data today from a Phase III trial of its nanoparticle formulation of loteprednol etabonate as a treatment for inflammation and pain in cataract surgery patients. The KPI-121 1% suspension met both primary efficacy endpoints and secondary endpoints and was well tolerated by the trial’s participants.
The Waltham, Mass.-based company’s KPI-121 uses Kala’s mucus-penetrating particle technology to deliver drugs to tissues in the eye. In preclinical studies, MPP tech increased loteprednol etabonate delivery to ocular tissues 4-fold, according to the company.
The Phase III trial enrolled 520 patients with anterior ocular inflammation after cataract surgery and randomized them to receive the KPI-121 1% or a placebo twice a day for 2 weeks. The primary efficacy endpoints were the proportion of patients with complete resolution of anterior chamber cells at day 8 and the proportion of participants with Grade 0 pain in the study eye after 8 days.
The study met both primary endpoints and achieved its secondary endpoints, including compete resolution of anterior chamber flare at day 4 and complete resolution of pain after 4 days.
“The significant improvement in the treatment of inflammation and pain with twice-a-day dosing of KPI-121 in this trial builds on the success of our first Phase III trial in cataract surgery,” chief medical officer Kim Brazzell said in prepared remarks. “We believe KPI-121 represents an important, near-term product opportunity for Kala as the 1st twice-a-day dosed steroid product for patients with post-operative inflammation and pain following ocular surgery. Based on the success of this trial, our plan is to submit a New Drug Application to the FDA for KPI-121 1% for the treatment of post-operative inflammation and pain following ocular surgery in late 2017.”
“Rapid and effective relief of pain and inflammation is the key goal of the management of patients following ocular surgery,” Dr. Edward Holland from the Cincinnati Eye Institute added. “With proven safety and efficacy with a twice-a-day dosing regimen, KPI-121 1% will add an important tool to our post-operative armamentarium as a safe, effective and convenient alternative to currently marketed topical corticosteroids, which are all recommended for dosing 4 times a day.”