Endpoint achieved in phase 2 trial of OTX-DED for short-term dry eye disease treatment
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OTX-DED met the primary endpoint in a phase 2 trial investigating the ophthalmic insert for safety and efficacy in the short-term treatment of dry eye disease, according to a press release from Ocular Therapeutix.
In the randomized, double-masked, vehicle-controlled, multicenter trial, OTX-DED (dexamethasone intracanalicular ophthalmic insert) showed statistically significant improvement in bulbar conjunctival hyperemia, the primary endpoint.
One hundred sixty-six subjects were enrolled in the modified intent-to-treat population and were randomly assigned to receive OTX-DED 0.2 mg, OTX-DED 0.3 mg or vehicle hydrogel.
Subjects who received OTX-DED 0.2 mg had a change from baseline of –0.51 on the CCLRU grading scale, and subjects who received the 0.3 mg formulation had a change from baseline of –0.43. Those in the vehicle arm had a change of –0.21. The changes were statistically significant compared with vehicle (P = .004 for 0.2 mg and P = .028 for 0.3 mg).
Visual analog scale dry eye symptoms, a secondary endpoint, improved in both treatment groups, but the differences were not significant compared with vehicle.
Both formulations were well tolerated and had a favorable safety profile. There were no ocular serious adverse events. Ocular adverse events in the OTX-DED groups included epiphora in 8.1% of subjects and increased IOP in 3.6% of subjects.
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