FDA Clears Optovue Blood Vessel Measurement Technology

Optovue Inc. has received FDA 510(k) clearance of AngioAnalytics, an optical coherence tomography angiography (OCTA) blood vessel measurement technology, to help clinicians manage diseases that cause progressive blindness.

The company also received clearance for its 3D projection artifact removal (PAR) software, which greatly improves OCTA image quality and enables accurate measurement and interpretation of OCTA images. AngioAnalytics and 3D PAR are commercially available in the U.S.

“AngioAnalytics and 3D PAR are game changers because they erase overlying inner retinal blood vessel artifacts, allowing for better visualization and more accurate measurement of the outer retina and choroidal structures, essential in treating the abnormal blood vessel growth (CNV membrane) that leads to blindness for patients with wet age-related macular degeneration (AMD),” said Paul E. Tornambe, with Retinal Consultants of San Diego. “In the past, we’ve relied on 2D imaging to determine the presence or absence of fluid leaking from these abnormal vessels in the retina, and whether or not additional treatment is necessary with VEGF inhibitor drugs. My personal evaluation of AngioAnalytics suggests we now have another way to monitor or determine if additional treatment is necessary by documenting how the drug affects a specific CNV membrane in a specific patient, and how long that effect lasts.”

AngioAnalytics brings objective data and analysis to Optovue’s commercially available AngioVue OCTA technology that provides high-resolution imaging of retinal blood vessels. Combined, the two technologies create color-encoded maps of the vessel densities of the retina or optic nerve for analyses of areas where there is blood vessel loss and abnormal blood vessel growth. The maps also provide several parameters to assess change to the foveal avascular zone — an area of the retina profoundly affected by diabetic retinopathy. The new AngioAnalytics software also supplies trend analysis so that physicians can objectively monitor retinal and vascular changes caused by disease progression or from treatment.

“We are thrilled to receive marketing clearance for our innovative AngioAnalytics technology as part of the AngioVue System to aid physicians in the early detection and management of sight-threatening eye diseases in the U.S.,” said Jay Wei, founder and chief executive officer of Optovue. “Analytic measurement tools will shift the treatment paradigm because they provide an objective measure of treatment efficacy, thereby enabling truly customized patient management and improved patient care. The information provided by AngioAnalytics may help to change the clinical management of diabetic retinopathy, age-related macular degeneration, and other diseases that progressively cause blindness for millions of people.”

Optovue is an ophthalmic device company that develops spectral-domain optical coherence tomography devices to improve diagnosis and therapy of ocular diseases.