The U.S. Food and Drug Administration (FDA) has given tentative approval to latanoprost 0.005% ophthalmic solution (Apotex Inc., Toronto) for the treatment of glaucoma, the FDA said on its Web site. Latanoprost is marketed under the brand name Xalatan (Pfizer, New York) and is indicated for the treatment of high intraocular pressure in patients with primary open angle glaucoma.

The U.S. Food and Drug Administration (FDA) has issued a warning to Miami Beach-based researcher Leslie Baumann, M.D., regarding promotional statements she made about Ipsen Biopharm’s (Paris) injectable frown line treatment Dysport (abobotulinumtoxinA), the FDA said in a letter.
Dr. Baumann’s promotional statements about Dysport, which were made to two magazines and NBC’s “Today Show,” were reportedly made in 2006, prior to the drug’s FDA approval. The statements were therefore in violation of the FDA’s regulations on pre-approval promotion, the agency said in its letter.
Dr. Baumann was involved as a researcher in Phase III trials of Dysport, also known as Reloxin, at the time she made the promotional statements, the FDA stated.
Dr. Baumann’s statements about Dysport included claims that its effects “last a month longer than Botox (onabotulinumtoxinA, Allergan, Irvine, Calif.),” the FDA letter cited. The FDA approved Dysport for treating forehead wrinkles and frown lines last spring. Ipsen granted distribution rights for the drug’s cosmetic use to Medicis (Scottsdale, Ariz).

Oxford BioMedica UK Ltd. (Oxford, U.K.) has entered into a license agreement with the Research Development Foundation, the technology transfer arm of the Clayton Foundation for Research (Houston), the company said in a press release.
The terms of the agreement give Oxford BioMedica exclusive rights to intellectual property that supports its gene-based ocular products RetinoStat and EncorStat. Oxford BioMedica will make an upfront payment and royalties on sales, the company said in the release.
The intellectual property details “a novel method for effective delivery of anti-angiogenic genes to the eye using lentiviral vectors,” the company said in the release.

New York Governor David A. Paterson has proposed legislation that would increase transparency and promote competition among pharmacy benefit managers (PBMs) by requiring them to disclose additional drug information to health plans, doctors, and patients.
“PBMs perform a valuable service, but there is little oversight of their practices and little competition,” said New York State Health Commissioner Richard Daines, M.D., in the release. “The three largest PBMs—Medco, Caremark, and Express Scripts—manage pharmacy benefits for 200 million Americans, 95% of those who have prescription drug coverage.”
Under Paterson’s bill, PBMs would be required to disclose the actual use of drugs by the health plan’s participants, any conflict of interest that the PBM might have with the health plan, any increase in the net price to the health plan for a covered drug and the reason for the increase, and all contracts entered into by the PBM with a network pharmacy or pharmaceutical manufacturer. The bill would also notify patients and disclose any relevant clinical and financial information to prescribers before a PBM could switch a patient to a more expensive drug, the governor said in the press release.

The inactivation of the 16INK4A gene may play a key role in the progression of retinoblastoma, said researchers at Thomas Jefferson University’s Sbarro Institute for Cancer Research and Molecular Medicine (Philadelphia, Pa.) in a press release.
In a recent study, published in the Journal of Cellular Physiology, researchers focused on the 16INK4A due to its suspected role in retinoblastoma progression and its link to familial cancer predisposition.
In the study, Marco G. Paggi, M.D., Ph.D., and colleagues assessed blood samples taken from 29 patients and their parents. They found low to moderate 16INK4A protein expression in five of 11 (45%) retinoblastoma tumor specimens. They also found reduced p16INK4a RNA expression in blood in 16 of 29 (55%) retinoblastoma patients compared to normal controls. This reduction was associated with the depletion of the p16INK4a gene, the researchers said in the release.
The researchers also found reduced expression in at least one parent among nine of the 16 (56%) patients with reduced p16INK4a RNA expression. This suggests a heritable susceptibility to retinoblastoma, the researchers said.

Lead-based eye makeup used by ancient Egyptians appears to have had antibacterial mechanisms that may have helped prevent common infections, said researchers from Paris’ École Normale Supérieure in a news report.
In a study originally published in Analytical Chemistry, Christian Amatore, Ph.D., and colleagues used electron microscopy and X-ray diffraction to assess 52 samples from containers of preserved makeup at the Louvre. 
The makeup consisted primarily of four lead-based chemicals: galena, cerussite, laurionite, and phosgenite, the researchers said in the news report. Due to deterioration of the makeup samples over the centuries, the researchers were unable to identify what percent of the makeup was lead. The researchers contend that during periods in which the Nile River flooded, the population was particularly vulnerable to infections caused by particles that entered the eye, causing inflammation. 
The dosage of lead in the makeup was a key factor in its potential benefits, Dr. Amatore said in the news report.

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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