Biopharmaceutical company Stealth BioTherapeutics reported on Monday the receipt of the US Food and Drug Administration (FDA) Fast Track designation for elamipretide for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy.

AMD is a progressive eye condition which is the leading cause of blindness in the elderly. AMD affects the center portion of the retina, called the macula, which is responsible for central vision and colour perception. The disease is a major contributor to loss of independence and diminished quality of life in older persons.

In early 2019, the company intends to launch a Phase 2b, randomised, double-masked, placebo-controlled clinical study to evaluate the safety and efficacy of subcutaneous injections of elamipretide in patients with dry AMD with geographic atrophy.

The company is investigating its lead product candidate elamipretide in three primary mitochondrial diseases, primary mitochondrial myopathy, Barth syndrome and Leber's hereditary optic neuropathy, for which it has both Fast Track and Orphan Drug designations. It is investigating elamipretide in dry age-related macular degeneration and has a broad pipeline of novel mitochondria-targeting compounds evaluating for new indications, including neurodegenerative diseases.