Two New Ophthalmic Surgical Products Approved by FDA
The FDA has approved Akten Ophthalmic Gel 3.5% -- a topical, ocular anesthetic formulation -- and Healon D viscoelastic -- a clear dispersive ophthalmic viscosurgical device.
Akten is a novel, unit-dose, preservative-free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent, according to Akorn, the product's maker. Akten can be used in cataract surgery, refractive surgery, Lasik surgery, and intravitreal injection.
Healon D's formula provides exceptional clarity in the surgical field and a high degree of protection of corneal endothelial cells, says Advanced Medical Optics, the product's manufacturer. Due to its low molecular weight, Healon D coats the cornea and remains in place throughout the entire surgical Process; its lower viscosity is said to provide ideal lubrication of IOL insertion systems. Healon D is latex-free.
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