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Isunakinra does not meet primary endpoint in phase 3 trial for allergic conjunctivitis
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Isunakinra did not meet its primary endpoint of achieving statistically significant results in ocular itching in a phase 3 trial, according to a press release from Eleven Biotherapeutics.
The phase 3 clinical trial included 258 patients with moderate to severe allergic conjunctivitis who were randomized to receive treatment with isunakinra (EBI-005) or vehicle control. Patients received treatment for 4 weeks.
Researchers found no statistically significant differences between the isunakinra group and the vehicle control group regarding the primary endpoint of ocular itching or any secondary endpoints, the release said.
Isunakinra was well tolerated, 94% of the patients completed the trial, and no serious adverse events were reported.
“We are disappointed that isunakinra failed to meet its primary endpoint, and based on these overall results, we see no immediate path forward in allergic conjunctivitis. Our efforts will be focused on submitting an investigational new drug application for EBI-031 in diabetic macular edema in the first half of 2016,” Abbie Celniker, PhD, president and CEO of Eleven Biotherapeutics, said in the release.