Dextenza reduces signs of inflammatory dry eye in phase 2 exploratory trial

Dextenza showed promising results in a phase 2 exploratory clinical trial in the treatment of inflammatory dry eye disease, Ocular Therapeutix announced in a press release.

The prospective, randomized, vehicle controlled phase 2 trial, conducted at two sites in the U.S., included 86 eyes of 43 patients.

Patients initially received a placebo vehicle depot for 45 days. Those who responded to the placebo vehicle were excluded from the 30-day treatment phase of the trial. Those who continued to show signs and symptoms of dry eye during the initial 45 days were enrolled for the treatment phase and randomized 1:1 to receive Dextenza (sustained-release dexamethasone) depot or a placebo vehicle depot.

Staining scores after randomization were significantly reduced from baseline in the Dextenza group compared with the placebo group; the between-group difference was significant (P = .018).

In addition, inferior staining showed significant change from baseline in the study group. Lissamine green staining also showed significant improvement.

Dextenza was well tolerated, and no IOP spikes were reported.

The drug depot was retained in 96% of eyes through 30 days in the treatment phase of the trial.