Stealth BioTherapeutics reports results from ReVIEW study of Ocuvia in DME patients

The results were presented in New York City at Stealth’s second Mitochondrial Science and Medicine Series symposium focused on mitochondria’s role in ophthalmology.

ReVIEW, a clinical study of DME patients, evaluated the safety, tolerability and efficacy of Ocuvia, an investigational drug targeting mitochondrial dysfunction to treat common and rare diseases.

Retinal vessel leakage and accumulation of macular fluid cause DME, leading to blurry or washed-out vision and often blindness. To date, standard care for macular diseases has been limited primarily to inhibiting angiogenesis with anti-VEGF therapies, rather than modifying disease progression by treating the underlying mitochondrial dysfunction.

ReVIEW evaluated 15 DME patients receiving Ocuvia as a monotherapy for 28 days. Patients were randomized to 0.3- and 1%- topical Ocuvia drops in ascending-dose cohorts.

Ocuvia met its primary safety and tolerability endpoints including no significant decreases in visual acuity during treatment. Ocuvia also reduced central subfield thickness by 32 and 27% in both a 0.3- and 1%- treated patient, respectively, without a change in the untreated eye.

"Although ReVIEW was a safety and tolerability study, a reduction of macular edema in these patients demonstrates Ocuvia’s potential," said Dr. Jeffrey Heier, a leading retinal specialist. "Ocuvia holds promise for patients to complement and improve retinal care," added Dr. Heier.

"Ocuvia may be the new paradigm for ophthalmology, reversing disease rather than just slowing angiogenesis," commented Dr. Pravin Dugel, Chairman for the American Academy of Ophthalmology Subspecialty Day, when describing Ocuvia’s clinical benefits and the role of mitochondria in eye diseases.

Stealth’s Mitochondrial Science and Medicine Series also featured Dr. Scott Cousins, an age-related macular degeneration (AMD) researcher and clinician. Dr. Cousins presented positive results with Ocuvia in dry AMD, including studies recently highlighted in Retina Today.

The symposium concluded with Dr. Alfredo Sadun, a renowned neuro-ophthalmologist, speaking on rare mitochondrial optic neuropathies common to more than 20 orphan inherited diseases. Stealth is initiating a clinical study in inherited optic neuropathies with its ReSIGHT trial for Leber’s Hereditary Optic Neuropathy, a rare genetic mitochondrial disease causing sudden and permanent loss of vision.

"ReVIEW’s results are encouraging and demonstrate the importance of mitochondria in debilitating diseases of the eye," said Chief Executive Officer Travis Wilson.

"We continue to broaden our ophthalmology program with Ocuvia, recruiting for the ReSIGHT study later this year, and initiating trials in rare anterior segment diseases and corneal dystrophies, both underserved patient populations with few treatment options."