Mixed results for TopiVert's dry eye drug candidate

UK clinical-stage biotech TopiVert Pharma today announced mixed top-line results from THEIA-1 Phase IIb/III 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 IIb/III study, investigated the efficacy and safety of TOP1630 0.1% Ophthalmic Solution compared to vehicle control (placebo) over a four-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 pre-specified endpoints compared to placebo including ocular discomfort, eye dryness and the Ocular Surface Disease Index (OSDI; Allergan, Irvine, CA).