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Dextenza meets one of two primary endpoints in phase 3 allergic conjunctivitis clinical trial
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Dextenza has met the primary endpoint for treating ocular itching associated with allergic conjunctivitis in a phase 3 clinical trial, Ocular Therapeutix announced in a press release.
For ocular itching, the Dextenza (sustained-release dexamethasone 0.4 mg) group showed a mean score of greater than 0.5 units at all time points and greater than 1 unit at a majority of the time points on day 7 after insertion compared with a placebo group (P < .0001) .
The Dextenza group did not achieve the primary endpoint for treating conjunctival redness, the release said.
Treatment success for the two indications was evaluated separately. Reaching endpoints for both ocular itching and conjunctival redness has not been historically required by the FDA for the approval of drugs for allergic conjunctivitis, the release said.
“Based on the results from this trial, we expect to advance this program into a second phase 3 clinical trial in allergic conjunctivitis before the end of 2015. We believe the results from this trial, as well as data from the previous phase 2 study, provide evidence supporting the safety and efficacy of our sustained-release drug delivery platform that we continue to leverage across multiple ocular diseases and conditions,” Amar Sawhney, PhD, chairman, CEO and president of Ocular Therapeutix, said in the release.