FDA Grants Premarket Approval to Bausch Health’s StableVisc OVD

FDA Grants Premarket Approval to Bausch Health’s StableVisc OVD

March 10, 2023
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Bausch Health Companies has received premarket approval from the US Food and Drug Administration (FDA) for its StableVisc Ophthalmic Viscosurgical Device (OVD) used in cataracts surgery.

Cataract surgery is a common surgical procedure that involves removing the natural lens of the eye and replacing it with an artificial intraocular lens (IOL). Cataracts are a common condition that develops as we age, causing the lens of the eye to become cloudy and impairing vision.

StableVisc Ophthalmic Viscosurgical Device (OVD) is a thick, transparent fluid utilized during cataract surgery when the eye's natural lens has become cloudy, hindering vision. The StableVisc OVD helps protect eye tissues. StableVisc OVD is injected from a syringe into the eye during cataract surgery.

During cataract surgery, StableVisc Ophthalmic Viscosurgical Device (OVD) is used to prevent tissue damage, including the significant loss of endothelial cells, which are located on the back of the cornea and maintain its clarity by removing fluids. If there are not enough endothelial cells, the cornea becomes hazy and vision is impaired.

A study compared StableVisc OVD to a similar FDA-approved OVD and found that three months after cataract surgery, the average loss of endothelial cells was not significantly different between those who received StableVisc OVD (17.5 cells for every 100) and those who received the already approved device (16.9 cells for every 100). The safety and effectiveness of StableVisc OVD were thus established to be comparable to the already approved OVD.