Stealth BioTherapeutics Announces Results In Ocuvia Diabetic Macular Edema Study: The ReVIEW Trial

BOSTON--(BUSINESS WIRE)--Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, today announced results from its ReVIEW study of Ocuvia in diabetic macular edema (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’s results are encouraging and demonstrate the importance of mitochondria in debilitating diseases of the eye”

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.”

For additional information on Ocuvia and its ReVIEW or ReSIGHT trials, please refer to Stealth's website.

Mitochondria, The Cell’s Powerhouse

Mitochondria are the cell’s powerhouse, responsible for more than 90% of the energy our bodies need to sustain life and support growth. The energetics from mitochondria maintain healthy physiology and prevent disease. In many common and rare diseases, dysfunctional mitochondria are a key component of disease progression.

About Mitochondrial Optic Neuropathies

Mitochondrial optic neuropathies include a broad group of orphan genetic diseases that cause vision loss due to mitochondrial dysfunction. Affecting more than 1 in 10,000 individuals, optic neuropathies are common to over 20 inherited mitochondrial diseases.

About Bendavia™ and Ocuvia™

Stealth’s lead candidates, Bendavia and Ocuvia, are investigational drugs with the potential to modify disease through mitoprotection—the ability to preserve energetics and restore normal energy production in mitochondria, while decreasing oxidative stress. These clinical candidates are being developed for both common and rare diseases including inherited mitochondrial diseases, where there are no FDA-approved treatments. The underlying science of Bendavia and Ocuvia is supported by more than 100 independent, peer-reviewed publications and abstracts. These mitochondrial-targeted candidates represent a novel therapeutic approach to address a wide variety of diseases having unmet treatment needs.

Stealth BioTherapeutics: Leading Mitochondrial Medicine

Stealth BioTherapeutics is a privately held biopharmaceutical company committed to bringing mitochondria therapies to patients to treat both common and rare diseases. As an important and common element in a variety of serious, debilitating diseases, mitochondria—the cell’s energy source—offer a promising, and yet untapped, target to modify diseases with significant unmet treatment needs. Stealth’s clinical development program is focused along several core therapeutic areas, including cardio-renal diseases, ophthalmic disorders and orphan mitochondrial diseases. By defining the broad potential of its mitochondrial platform and therapies, Stealth is leading mitochondrial medicine.

More information regarding Stealth and its pipeline is available at StealthBT.com.