Herantis Pharma has initiated Phase 2 study with Cis-UCA Eye Drops in Patients with Dry Eye Syndrome, results expected in Q3/2015
Herantis Pharma Plc. has initiated its Phase 2 clinical study with Cis-UCA Eye Drops in patients with dry eye syndrome. In the study, 150 patients with Dry Eye Syndrome will be randomized to receive 4 weeks of treatment with either placebo eye drops or two different strengths of cis-UCA Eye Drops. The objective of the study is to compare the safety and efficacy of Cis-UCA Eye Drops to placebo, for the treatment of the signs and symptoms of Dry Eye Syndrome.
This study will be conducted in the USA by Ora, Inc., who has worked with Herantis on cis-UCA development for the past three years, including supporting requirements for clinical supply manufacturing, preclinical efficacy screening and regulatory guidance and interface.
"Cis-UCA development program has progressed well thanks to a great team and strong commitment in the project by the involved parties", appreciates Pekka Simula, CEO of Herantis Pharma. "While the rate of patient recruitment is always difficult to estimate, our partner Ora, Inc. has developed an efficient system to study dry eye that directly combats the variability, such as slow patient recruitment, seen in these studies. We now believe that we can announce top-line data from the study already by September 2015."
Herantis Pharma aims to publish top-line data of the Phase 2 study by September 2015. The company had previously estimated that top-line results would be announced by the end of 2015.
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