The FDA and CDC officials announced that they have received reports of adverse events associated with the use of gentamicin ophthalmic ointment (0.3%) for prophylaxis against ophthalmia neonatorum or neonatal conjunctivitis. The product is marketed by Lake Forest, Ill.-based Akorn Inc as Gentak. The cases, which occurred in multiple locales and included product from several lots, have involved eyelid swelling and dermatitis that appears a few days after ointment application. Most cases have been mild and have not required additional treatment, but more severe cases have been associated with blistering of the skin.

Pharmaceuticals are increasing for production of AzaSite (azithromycin ophthalmic solution) 1 percent in the US and Canada in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%). Erythromycin ophthalmic ointment is approved for prophylaxis of ophthalmia neonatorum, a form of bacterial conjunctivitis that may be contracted by newborns during delivery. The ointment was placed on the FDA’s Drug Shortage list.

The FDA has approved Ista Pharmaceuticals’ bepotastine besilate ophthalmic solution 1.5% as a twice-daily eye drop for treating ocular itching due to allergic conjunctivitis. Bepreve (bepotastine besilate ophthalmic solution 1.5%) is a non-sedating, highly selective histamine receptor antagonist that stabilizes mast cells and suppresses the migration of eosinophils through inflamed tissue.

The FDA has approved a new antibacterial eyedrop called Besivance for the treatment of a contagious eye infection called bacterial conjunctivitis, commonly known as “pinkeye.” Symptoms of bacterial conjunctivitis include red eyes, swelling, eyelids sticking together, itching, watering, and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis generally runs its course in seven to 14 days. Although this infection is common among kids, it can also affect people of other ages.

InSite Vision Incorporated has announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb’s besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision’s DuraSite® patented drug delivery system. DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. DuraSite enables a less frequent dosing schedule, increased patient compliance, and increased efficacy.

Akorn, Inc. has announced that the U.S. Food and Drug Administration has granted approval for Akorn’s Abbreviated New Drug Application (ANDA) for Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%. Ciprofloxacin HCl Ophthalmic Solution is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. Annual sales for Ciprofloxacin HCl Ophthalmic Solution are approximately $20 million, according to IMS sales data. Akorn expects to launch Ciprofloxacin in 2009. Of the 20 product approvals received in 2008, 8 were launched in 2008 and 10 are scheduled for launch in the first half of 2009.

Bausch & Lomb has announced that its pink eye drug besifloxacin is currently is likely to get recommended by the FDA. Its Dermatologic and Ophthalmic Drugs Advisory Committee voted to recommend approval for besifloxacin 0.6. The drug is required for treatment of bacterial conjunctivitis. Bausch & Lomb plans to start marketing besifloxacin in the U.S. in 2009, pending FDA approval. It can be added that Conjunctivitis is an inflammation of the conjunctiva most commonly due to an allergic reaction or an infection.

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.

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.