Thursday, June 25, 2015

Results in Ocuvia Diabetic Macular Edema Study show promise

ReVIEW study outcomes so far indicated that Ocuvia, a investigational topical ophthalmic formulation to treat the underlying defects in mitochondria in retinal diseases, shows promise in patients with diabetic macular edema.

(c) Stealth BioTherapeutics Inc
Results of the ReVIEW study of Ocuvia in diabetic macular edema (DME) patients were recently presented in New York City at Stealth BioTherapeutics’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.

According to Dr. Jeffrey Heier, although ReVIEW was a safety and tolerability study, a reduction of macular edema in these patients demonstrates Ocuvia’s potential, while Dr. Previn Dugel felt that Ocuvia may be the new paradigm for ophthalmology, reversing disease rather than just slowing angiogenesis.

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.

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