PhIII setback mars Ocular's glaucoma drug/device, though company remains 'encouraged' by data breakdown
Ocular Therapeutix’s latest drug/device — for glaucoma — has flopped in its Phase III study, failing the primary endpoint to significantly reduce intraocular pressure versus placebo.
The treatment, OTX-TP, is an intracanalicular insert designed to deliver a formulation of the drug travoprost with an effect up to 90 days, which Ocular says can solve the adherence issues seen with daily eye drop regimens that patients are typically prescribed.
Investigators tracked the change in IOP from baseline in 554 patients in the study over several months, taking measurements at nine time points: 8 am, 10 am and 4 pm on one day at 2, 6 and 12 weeks following insertion. The first six sessions, the company says, were just fine — recording statistically significant reductions of IOP with p-values as low as 0.001 — but the seventh threw them off.
In fact, as they lay out in a table, that’s the only time point where OTX-TP did not achieve a statistically significant reduction of IOP compared to placebo.
“We are encouraged by the results of this trial which shows OTX-TP’s ability to lower IOP out to 12 weeks with a single insert using this novel dosage form,” said chief medical officer Michael Goldstein, adding that his team will now take the data to the FDA to determine next steps.
Ocular’s relationship with the FDA, though, has not always been smooth. Its first drug/device eye treatment, Dextenza, was rejected twice before nabbing an approval, forcing a restructuring that claimed a fifth of its staff. The company finally managed to sort out the manufacturing issue and began marketing the therapy for post-surgical pain late last year.
Some investors aren’t sticking around. Shares $OCUL are still down 12% (to $3.37) in pre-market trading, following the announcement at Monday close.