Tears flow as Ocular’s first attempt at dry eye disease fails

Top-line data from a phase 2 trial of OTX-CSI in dry eye disease suggests there is little for Ocular Therapeutics to salvage. Not only was the primary endpoint – increased tear production at 12 weeks – missed, but control patients showed stronger improvements. Non-significant trends in favour of OTX-CSI were seen on other measures, but the results provide few reasons to press on. OTX-CSI is a cyclosporine intracanalicular insert and is based on the same technology as the company’s marketed product Dextenza. This involves encapsulating an active ingredient and plugging it into the tiny holes around the eye, where it is slowly released. Dry eye is a very tricky setting in which to show an effect, and many developers have struggled here, though Ocular does have another shot with OTX-DED. This utilises dexamethasone and will yield phase 2 data in the first quarter of 2022. The 32% plunge in Ocular’s shares this morning seems drastic considering that few hopes can have been attached to OTX-CSI. Perhaps investors feel these results lower the chance of success from the remainder of the company’s pipeline projects, which rely on the same technology.

A high risk pipeline? Ocular Therapeutics' follow-on projects
OTX-TKI Axitinib intravitreal implant  Ph1 AMD trial recently started.  
OTX-TIC Travoprost intracameral implant  Ph2 glaucoma trial slated to start Q4'21.
OTX-CSI Cyclosporine intracanalicular insert Ph2 dry eye study fails October 2021
OTX-DED Dexamethasone intracanalicular insert Ph2 episodic dry eye trial due to report Q2'22. 
Source: Company statements.

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