Phase III trial of Dextenza (sustained release dexamethasone) meets primary endpoint in allergic conjunctivitis- Ocular Therapeutix

Ocular Therapeutix has announced topline efficacy results from a Phase III clinical trial to evaluate the safety and efficacy of Dextenza (sustained release dexamethasone) 0.4 mg, intracanalicular depot for the treatment of allergic conjunctivitis. Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular depot and designed for extended drug release to the ocular surface for 30 days. The primary endpoint of treatment of ocular itching associated with allergic conjunctivitis was successfully achieved in this trial. There was a statistically significant difference (p<0.0001) in the mean scores between the Dextenza treatment group and the placebo group for ocular itching at all three time points measured on day 7 post-insertion of the drug product.

The difference in the scores for ocular itching between the Dextenza group and the placebo group was greater than 0.5 units at all time points on day 7 post-insertion and was greater than 1 unit at a majority of the time points on day 7 post-insertion. The primary endpoint of conjunctival redness is typically an endpoint included in Phase III trials for allergic conjunctivitis but has not been required for approval. The Dextenza treatment group did not achieve the primary endpoints for conjunctival redness in this trial. Many commercially available prescription medications for the treatment of allergic conjunctivitis have an ocular itching indication only. In this clinical trial, as well as other clinical trials completed to date, Dextenza has exhibited a good safety profile and has been well tolerated.

Comment: Dextenza met its first primary endpoint of relieving ocular itching related to conjunctivitis but missed the mark on its co-primary goal, reducing redness. The company noted that redness reduction has never been a requirement for FDA approval in allergic conjunctivitis, and it is not changing its plans for a second Phase III study for later this year.