By penetrating the mucosal barrier in the eye, Kala’s Mucosal Penetrating Products (MPPs) “enhances pharmacokinetics” and can be used to treat both anterior and posterior segment disorders.
Top-line results from a Phase 3 clinical trial of KPI-121 (loteprednol) achieved all primary efficacy endpoints in the treatment of inflammation and pain post-cataract surgery. A phase 2/3 study for dry eye achieved statistical significance at weeks 2 and 4 for the primary sign endpoint of bulbar conjunctival hyperemia, and “promising trends were observed for key symptom endpoints,” but “just missed” statistical significance in the intent-to-treat population, McDermott said. An additional phase 2 study on KP-121 for meibomian gland disease should be fully enrolled by summer.
The company is also developing its own novel receptor tynase kinase inhibitors (RTKi) targeting VEGF receptors. To date, results in animal studies are “promising” and the company expects to begin human studies this summer.
Mr. McDermott has 20 years of operating experience in the biotechnology and ophthalmology industries and currently serves as Kala’s Interim President and CBO.