Phase II study of Egp-437 demonstrated significant improvements in signs and symptoms of dry eye
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EyeGate has announced that EGP-437, a corticosteroid solution administered by a non-invasive ocular drug delivery system, has improved signs and symptoms in patients with dry eye syndrome (DES). The findings are based on the analysis of a Phase II study.
The study evaluated the safety and efficacy of a corticosteroid solution (EGP-437) administered by the EyeGate II Delivery System twice over a three-week period.
In the top-level analysis, investigators observed that EGP-437 significantly improved signs and symptoms of DES during the three-week environmental component, which included three CAE exposures and two doses. EGP-437 also improved signs and symptoms when studied as a treatment and preventative in conjunction with the CAE.
George Ousler, Director of Dry Eye Department at Ora, said: “This exploratory Phase II study demonstrated significant improvements in signs and symptoms of dry eye during and after CAE exposure following EGP-437 dosing. These effects were observed within hours of dosing, suggesting a rapid onset of action. In addition, EGP-437 significantly improved the post-CAE recovery for patients in the active treatment groups. The impact on signs and symptoms was also observed during the study’s three-week environmental component, further supporting the potential benefits of EGP-437 for these patients.”
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