Ocular Therapeutix' glaucoma candidate fails in Phase III study

USA-based biotech firm Ocular Therapeutix (Nasdaq: OCUL) late Monday announced top-line results from the first pivotal Phase III clinical trial of OTX-TP, which failed to meet primary endpoint but achieved statistically-significant reduction of intraocular pressure versus placebo, with the news sending the firm’s shares plunging 16.91% to $2.80 in pre-market trading this morning.

OTX-TP is an intracanalicular insert that delivers a preservative-free formulation of the drug travoprost for the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. OTX-TP is designed to lower IOP for up to 90 days and to address the poor adherence associated with chronic, daily eye drop regimens, the current standard of care.

The Phase III randomized, double blind, placebo-controlled clinical trial was conducted across more than 50 sites and enrolled 554 subjects with open-angle glaucoma or ocular hypertension in the full analysis set (FAS) population. The trial’s primary efficacy endpoint was to demonstrate a statistically superior mean reduction of IOP from baseline for OTX-TP treated subjects compared with placebo insert treated subjects at nine different time points, three diurnal time points (8 AM, 10 AM, and 4 PM) at each of 2, 6, and 12 weeks following insertion.