Phase IIb/III of emixustat hydrochloride fails to meet endpoint in geographic atrophy- Acucela

Acucela has announced top-line results from the Phase IIb/III clinical trial (S.E.A.T.T.L.E. study) of the investigational visual cycle modulator emixustat hydrochloride in 508 patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study did not meet its primary endpoint with none of the treatment groups showing a significant difference in lesion growth rate from placebo. The lesion growth rates over 24 months for the 10mg, 5mg, 2.5mg and placebo groups were 1.84 mm2/year, 1.83 mm2/year, 1.69 mm2/year, 1.69 mm2/year, respectively. There was no significant difference in the mean change of best corrected visual acuity from baseline to month 24 between treatment groups. There was a small numerical treatment difference observed in certain patients with specific genetic profiles in favor of emixustat.

An analysis of the two-year clinical data from the S.E.A.T.T.L.E study showed that adverse events were similar to those seen in earlier trials of emixustat. They include delayed dark adaptation and chromatopsia. There appeared to be no imbalance in serious adverse events between emixustat and the placebo group. Further analysis of the clinical data from the S.E.A.T.T.L.E. study will be made in collaboration with Otsuka Pharmaceutical in the ensuing months. Acucela has an ongoing pilot study to explore the benefits of emixustat for the treatment of proliferative diabetic retinopathy. Acucela is also considering the initiation of a study to explore the potential benefits of emixustat in Stargardt Disease.