The U.S, Food and Drug Administration has approved Akorn, Inc.’s Akten™ Ophthalmic Gel 3.5%, the first approval to an ocular anesthetic in the last 40 years. The preservative free product is stored at room temperature and can be used in any ocular applications such as cataract surgery, Lasik surgery and refractive surgery that need a topical anesthetic. This is the company’s first NDA drug product developed internally.

The U.S. Food and Drug Administration (FDA) has approved Bausch & Lomb to commercially launch the Akreos™ Advanced Optics Aspheric Lens  (model AO60) (model AO60) in the market of United States. A foldable acrylic IOL, the lens is implanted with Bausch & Lomb’s single-use AI-28 inserter. This enables single-handed insertion through an un-enlarged standard phaco incision. The lens delivers quality vision, and enhanced contrast sensitivity. Its unique properties make Akreos lens a pathway to micro-incision cataract surgery. This will enable novel lens technologies that can be inserted through smaller incisions.

The U.S. Food and Drug Administration has tracked a new treatment in the form of a capsule that promises to benefit patients suffering from age-related macular degeneration (AMD) and retinitis pigmentosa. In both these vision disorders, retina’s light-sensitive cells that relay signals to the brain begin to degenerate over time. Ultimately, it results in vision loss. The suggested product is an innovation from a Lincoln, RI, biotech company Neurotech. The capsule consists of genetically engineered cells which produce a protein that helps in protects the light-sensitive cells in the retina.

FDC Ltd. has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Timolol Maleate Ophthalmic Solution. Timolol Maleate Ophthalmic Solution is a nonselective beta-blocking drug, used as a primary line of treatment for glaucoma.

Akorn announced that it has received FDA approval for its Ofloxacin Ophthalmic Solution USP, 0.3%. Ofloxacin Ophthalmic Solution USP, 0.3%, is the generic version of Ophthalmic Solution to treat infections caused by bacteria in conjunctivitis and corneal ulcers. The branded drug had generated sales of approximately $7.5 million in 2007. Akorn plans to manufacture the generic drug in its Decatur, Illinois, facility, and expects to launch the drug in the third quarter of 2008.