Ocular’s OTX-DED Succeeds In Dry Eye Where OTX-CSI Failed, But More Data Needed

The Phase II trial showed significant improvement in eye redness in patients with dry eye disease, but additional data are needed on DED symptom improvement.

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Ocular's OTX-DED has data sufficient to continue development in dry eye disease • Source: Shutterstock

Ocular Therapeutix, Inc. can move ahead with clinical development of its new dexamethasone ocular insert OTX-DED after showing statistically significant improvement in bulbar conjunctival hyperemia. However, the company will need to produce more data on how well the product works at actually improving dry eye symptoms, particularly as little separation appeared between the OTX-DED and vehicle hydrogel insert arms, especially entering a market that is getting crowded.

The company announced results of the randomized, double-masked Phase II study on 6 December. Among 166 patients enrolled in the modified intent-to-treat population, 55 received OTX-DED (dexamethasone intracanalicular ophthalmic insert) at 0.2mg, 56 received 0

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