TopiVert Pharma, a clinical-stage biotechnology company developing non-systemic kinase inhibitors (NSKIs) as novel, locally-acting medicines for the treatment of chronic inflammatory ocular diseases, announces the publication of the paper “A Phase 2 randomised, double-masked, placebo-controlled study of novel nonsystemic kinase inhibitor TOP1630 for the treatment of dry eye disease” in Clinical Ophthalmology.
In this notable study, TOP1630 produced statistically significant improvements in multiple symptom and sign endpoints compared with vehicle in both environmental and Controlled Adverse Environment (CAE; Ora) challenge settings. Positive assessments consistently favored TOP1630 across a broad range of symptom endpoints, including relief of ocular dryness, pain/ocular discomfort, foreign body discomfort, and grittiness. Consistent with the promising efficacy profile on symptoms, positive effects were seen for total, corneal, and conjunctival region staining scores. This finding is indicative of a benefit on the total ocular surface and this endpoint may represent the most relevant staining measure for dry eye compared with individual segmental scores. TOP1630 also demonstrated placebo-like safety and tolerability. The resultant TOP1630 benefit-risk profile for the treatment of dry eye disease is highly favorable, according to TopiVert Pharma.
Topline results from the study were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2018 annual meeting.
Based on this successful phase 2 study result and following discussion with the FDA, TopiVert is initiating a phase 2b/3 program in dry eye disease in 2019. The first study in this program THEIA-1 is anticipated to start recruiting subjects during Q1 2019. THEIA-1 is a multicenter, randomised, double-masked, placebo-controlled efficacy and safety study of 0.1% TOP1630 ophthalmic solution in dry eye subjects. This study is scheduled for completion in 2019 and represents an important component of the registration program for TOP1630.
“We are excited to publish, for the first time, results from our important clinical data demonstrating TOP1630’s convincing efficacy in treating both the symptoms and signs of dry eye disease with placebo-like tolerability,” Ajay Duggal, TopiVert’s Chief Medical Officer, said in a company news release. “These compelling clinical data support progression of TOP1630 to late-stage development for dry eye disease starting imminently with the THEIA-1 study, and the exploration of the use of NSKIs as potential treatments for other ocular inflammatory disorders.”