Ocular Therapeutix gave itself a low bar to clear in the latest phase III study of OTX-TP, pitting the glaucoma project against placebo rather than an active comparator – but even that was not low enough. The trial failed to show a decrease in intraocular pressure with OTX-TP, an eye insert that delivers travoprost, versus placebo, across the 12-week study. Despite the failure, Ocular still hopes the project has a future, highlighting an analysis of intraocular pressure at individual timepoints that it said showed a significant benefit with OTX-TP on eight of nine occasions. Still, as the primary endpoint was not hit, these findings can only be considered exploratory. And OTX-TP’s effect appeared to wane over time, raising questions about the company’s sustained delivery approach. Ocular will take the latest data to the FDA but even if the agency decides to be lenient, OTX-TP will struggle to find a place in the market – the project previously failed to beat an active comparator, generic timolol. Investors, who had hoped OTX-TP would fare better against placebo, sent Ocular’s stock down 17% in premarket trading today. Today’s failure might also bode ill for Ocular’s next project, OTX-TIC, a bioresorbable travoprost implant that is in phase I.
|Ocular Therapeutix's clinical-stage pipeline|
|OTX-TP||Travoprost insert||Glaucoma and ocular hypertension||Failed phase III|
|OTX-TIC||Travoprost implant||Glaucoma and ocular hypertension||Phase I|
|OTX-TKI||Tyrosine kinase inhibitor implant||Wet AMD, DME, RVO||Phase I|
|AMD: Age-related macular degeneration, DME: Diabetic macular edema, RVO: Retinal vein occlusion. Source: EvaluatePharma, company website.|