| Volume 10, Number 43 |
November 21, 2005
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GenTeal dry eye products recalled |
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| Novartis Ophthalmics (East Hanover, N.J.) has voluntarily recalled certain lots of GenTeal Gel and GenTeal GelDrops, according to the company. Mold was found in a small number of samples during sterility tests of GenTeal GelDrops, of which two lots were recalled: Lot #51139, 15 mL, expiration date 07/2007; and Lot #51283, 25 mL, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005. Five lots of GenTeal Gel were recalled: Lot #Z12468, 10 mL, expiration date 01/2006; Lot #Z12912, 3.5 mL, expiration date 03/2006; Lot #Z12900, 10 mL, expiration date 04/2006; Lot #Z13161, 10 mL, expiration date 05/2006; and Lot #Z13314, 3.5 mL, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in some, according to the company. Novartis officials stated they initiated the recall as a precautionary measure. The sterility assurance issues have been corrected, Novarits officials said. Only the two distributed GenTeal GelDrops lots are affected “Novartis Ophthalmics takes its mission of patient care and providing quality products very seriously, and therefore, believes it is necessary to take this precautionary action,” according to a company statement. The recalls are being conducted with the knowledge of the FDA, according to the statement. Consumers that have purchased GenTeal Gel or GenTeal GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336. |
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Advanced Medical Optics recalls AMO Endosol |
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All lots of AMO Endosol (Balanced Salt Solution, Advanced Medical Optics, Santa Ana, Calif.) manufactured by Cytosol Laboratories, Inc., have been recalled by Advanced Medical Optics now that some product samples have shown endotoxin levels above the USP maximum limit, according to information from the company. This recall affects only the U.S. market. AMO has directed customers to stop using AMO Endosol and return the product to the company. Products affected are all lots of 500 mL glass bottles (Product Code: END500, NDC: 23731-8100-5), 500 mL plastic bottles (Product Code: 0850; NDC: 23731-8100-1) and 18 mL plastic squeeze bottles (Products Code: 0997; NDC: 23731-8100-8). The recall comes eight days after AMO issued a safety alert to its customers regarding observations of Toxic Anterior Segment Syndrome in some patients who received surgery using AMO Endosol. TASS occurs when a contaminant enters the anterior segment during surgery and causes an inflammatory reaction. Customers returning AMO Endosol related to the recall should call the company at 1-800-366-6554.
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Allergan proposal to buy Inamed likely ‘superior’ |
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| Allergan (Irvine, Calif.), the second company to make an acquisition offer to Inamed (Santa Barbara, Calif.), likely made the “superior proposal,” according to a release from Inamed, an aesthetic surgery company. However, no agreement was reached by press time, according to the company. Allergan made the $3.2 billion offer after Medicis (Scottsdale, Ariz.) offered $2.8 billion in March. Inamed’s aesthetic brand names include Reloxin, which is similar to Allergan’s BOTOX Cosmetic (botulinum toxin type A). The acquisition would add to Allergan’s product portfolio a growth driver in the obesity market, according to Allergan. Allergan proposed to acquire Inamed Corporation for a per share consideration of $84 in cash or 0.8498 of a share of common Allergan stock. The Allergan proposal is reasonably likely to result in a “company superior proposal,” according to Inamed’s board of directors. |
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Study links bacteria and wet AMD |
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| Massachusetts Eye and Ear Infirmary, Boston, researchers have published a study that may establish a solid link between Chlamydia pneumoniae and AMD. The bacteria were found in five of nine affected specimens of eye tissue with wet AMD. More than 20 eyes that were not affected with AMD showed no signs of the bacteria, according to the study. The findings offer more evidence that AMD may be caused by inflammation, the researchers said. The study was published in the November issue of Graefe’s Archive for Clinical and Experimental Ophthalmology. “The paper showed that C. pneumoniae is capable of modifying the function of important cell types involved in regulating normal eye function,” study lead author Murat Kalayoglu, M.D. said in a prepared statement. “We found that C. pneumoniae infection led to increased production of vascular endothelial growth factor (VEGF), the key protein involved in wet AMD. That C. pneumoniae infection of human eye cell types increases VEGF production is therefore significant and could explain in part why VEGF levels are increased in many people with wet AMD,” Dr. Kalayoglu said. Recent research has found that nearly half of AMD cases can be explained by variations in a gene called Complement Factor H (CFH), which makes a protein that regulates the body’s immune and inflammatory responses. Chlamydia pneumoniae is linked to heart disease and has been a suspect in the cause of AMD. |
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EYEWORLD WEEK Online edited by David Laber and
Enette Ngoei
EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and
Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Monday,
distributed by e-mail, and posted live on Monday mornings.
Chief Medical Editors: Stephen A. Obstbaum, M.D., and Stephen S. Lane, M.D.
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Opinions expressed in EyeWorld Week do not necessarily reflect those of the ASCRS•ASOA.
Mention of products or services does not constitute an endorsement by the ASCRS•ASOA.
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