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news.Stealth BioTherapeutics has started a Phase 2 clinical study to assess the topical eye drop formulation of elamipretide for the treatment of patients with Fuchs’ corneal endothelial dystrophy (FCED).
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The company expects to report top-line data from the study in the third quarter of this year.
Under the phase 2 ReVEAL study, the company will assess the topical eye drop formulation of elamipretide in 16 subjects with mild to moderate corneal edema.
Patients will be treated with one drop of elamipretide twice daily in the randomly selected study eye and one drop of placebo solution twice daily in the control eye for 12 weeks.
The evaluation of safety and tolerability are the primary endpoints of the study. Secondary endpoints will calculate the reduction in central corneal thickness, enhancement in visual acuity and modification in endothelial cell count and morphology.
Stealth BioTherapeutics chief scientific officer Mark Bamberger said: "Many severe ocular diseases, including Fuchs’, are linked to dysfunctional mitochondria and are characterized by a state of increased oxidative stress and impaired energetic components of the eye.
"We are aiming to safely restore these energetics and to show a clinical benefit with elamipretide in visual acuity and other functional measures."
Elamipretide (formerly known as Bendavia and Ocuvia) preserves energetics and restores normal energy production in mitochondria, apart from decreasing oxidative stress.