TopiVert Pharma announced topline results from THEIA-1 phase 2b/3 clinical study evaluating TOP1630, a novel anti-inflammatory kinase inhibitor, as an ophthalmic solution for the treatment of dry eye disease.
THEIA-1, a multicenter, randomized, double-masked, placebo-controlled phase 2b/3 study, investigated the efficacy and safety of TOP1630 0.1% ophthalmic solution compared to vehicle control (placebo) over a 4-week period in 202 adult patients with moderate to severe dry eye disease.
The primary endpoints of the study, the efficacy of TOP1630 0.1% ophthalmic solution, compared to placebo at day 29 on ocular grittiness and total ocular surface staining, were not met. However, TOP1630 showed statistically and clinically relevant improvements on multiple prespecified endpoints compared to placebo including ocular discomfort, eye dryness and the ocular surface disease index (OSDI; Allergan Inc, Irvine, CA).
The study also showed that TOP1630 was safe and well tolerated with a low frequency of adverse drug reactions and a comfort profile following administration similar to placebo, as had been seen in an earlier trial.
“The primary endpoints for this study were selected based on the strength of data from a small single centre phase 1/2 study. While we are disappointed that these were not met in this larger, multicenter study, we believe that the positive and consistent effects seen on a number of the key pre-specified endpoints support efficacy with a competitive tolerability profile,” Ajay Duggal, TopiVert’s Chief Medical Officer, said in a company news release. “As differences between TOP1630 and placebo were increasing over time from many of the assessments, it suggests that plateau has not been reached at 4 weeks and there may be greater effects to be seen with longer duration of treatment. We will be working with our scientific advisors in the coming weeks to design the next study and define our regulatory pathway going forward.”
“The results from this study in patients with moderate to severe dry eye disease are encouraging with TOP1630 demonstrating clinically and statistically significant changes compared to placebo on many endpoints and a favorable tolerability profile,” Joseph Tauber, MD, Tauber Eye Centre Kansas City, Consultant Ophthalmologist, said in the news release. “Given the high unmet need in moderate to severe dry eye disease, the multifactorial etiology of the disease and the heterogeneous patient population, the emerging profile of TOP1630 as a novel anti-inflammatory agent is promising.”
Additional information about the THEIA-1 study, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03833388).