Infectious disease experts are reporting early signs that the swine-origin strain of the influenza A (H1N1) virus that caused illness in Mexico and the United States in March and April 2009 is making a comeback. As ophthalmologists are face-to-face with many patients every day, this increases the chances of contracting a highly transmissible virus, such as H1N1. However, by implementing simple strategies, clinicians can decrease the likelihood of having the virus penetrate their practice.

"Proximity likely increases the pro-bability of contact—the farther away you are from a source patient, the less likely you will be infected," says Judith Feinberg, MD, professor of medicine in the Division of Infectious Diseases at University of Cincinnati College of Medicine.

The Centers for Disease Control and Prevention expects cases, hospitalizations and deaths associated with H1N1 to increase in the United States into the fall and winter of this year. The H1N1 flu spreads through the coughs and sneezes of the infected people, but it may also be spread by people touching infected objects and then touching their face. Symptoms include fever, cough, sore throat, body aches, headache, chills, fatigue and sometimes nausea, vomiting and/or diarrhea, according to the CDC.

Hand-washing before and after seeing any patients with respiratory symptoms is imperative, but it is best to stop the virus from entering the office. Clinicians should tell patients with respiratory infections to stay home until they are well for at least a week and reschedule their elective visit, advises Richard P. Wenzel, MD, professor and chairman of the Department of Internal Medicine at Virginia Commonwealth University, in Richmond, Va. For example, when the receptionist calls to confirm the appointment, she can screen the patients by asking if they are sick with H1N1 symptoms and, if so, postpone the appointment.

Mack A. Land, MD, MACP, professor of medicine in the Division of Infectious Diseases at the University of Tennessee College of Medicine, in Memphis, Tenn. adds that if a patient presents with any upper respiratory symptoms, he should be immediately given a mask and sent home. "You don't want them infecting your whole waiting room when they are sitting out there," he says.

If the patient needs to be seen and he is having any kind of respiratory symptoms, even mild ones, the patient should be instructed to put on a surgical mask, recommends Dr. Wenzel. "This will protect the ophthalmologist to a great extent," he says. "I also would have all the patients wash their hands with an alcohol hand wash to protect the environment as well because this virus can hang around for hours."

Ophthalmologists also may choose to wear a mask. "If they have to examine a patient who has a respiratory infection, then physicians optimally would wear an N95 mask to protect themselves," he explains, noting that the N95 would block any kind of possible virus that might get around the surgical mask. "The surgical mask will do 90-percent of the job. If they wanted to be really sure for at least that up-close type of exam, the N95 mask would be an added protection."

Dr. Land points out that both the Institute of Medicine and current CDC guidelines recommend that the health-care provider should wear a N95 mask when dealing in close contact with people who may have influenza or H1N1.

All health-care providers should get the H1N1 vaccine, particularly ophthalmologists, because they are in such close quarters with patients, says Dr. Feinberg. The vaccine is anticipated to be available in mid-October or November. "The vaccine most likely will be two shots, approximately three to four weeks apart, although one-shot vaccine may become available," she says. Symptomatic clinicians or practice employees should not come to work. "Adults shed the virus for about five to seven days so ideally they would stay home for a week as not to transmit to their nurses, patients, or clerks," says Dr. Wenzel.

"Tamiflu (oseltamivir phosphate) may be helpful if it is taken soon after the onset of symptoms (within 24 to 36 hours)," Dr. Feinberg adds.

Infectious disease experts note they cannot predict the severity of the outbreak. "Signs indicate it could be substantial, because we had it already for months in the summer. We usually don't see flu in the summer," Dr. Wenzel says. "In late August and early September we saw an upsurge in cases as schools and colleges began. There is a lot of debate on how severe it will be, but it is highly transmissible so we are going to see an upsurge, and we will see some deaths." He adds that this virus is affecting people in their 20s and 30s (with and without underlying disease) particularly hard.

Also available is 10 Steps You Can Take: Actions for Novel H1N1 Influenza Planning and Response for Medical Offices and Outpatient Facilities at http://www.cdc.gov/h1n1flu/10steps.htm.

 

Sirion Drug Approved for Herpetic Keratitis

Also receiving FDA approval last month was Sirion Therapeutics' Zirgan (ganciclovir ophthalmic gel) 0.15% for herpetic keratitis (dendritic ulcers). The FDA granted orphan-drug designation to Zirgan for this indi-cation in April 2007.

The FDA approval was based on the results of clinical trials conducted in Europe, Asia and Africa that compared the efficacy and tolerability of Zirgan to acyclovir ophthalmic ointment 3% in patients with herpetic keratitis. Both ganciclovir gel and acyclovir ointment are standard-of-care therapies outside of the United States and selectively target the replication of HSV DNA, unlike older antivirals which affect both healthy and infected cells.

In one open-label, randomized, controlled, multicenter clinical trial that enrolled 164 patients with herpetic keratitis, Zirgan was non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution (percentage of healed ulcers) at day seven was achieved in 77 percent (55/71) for Zirgan versus 72 percent (48/67) for acyclovir.

In three randomized, single-masked, controlled, multicenter clinical trials that enrolled 213 patients, Zirgan was non-inferior to acyclovir in patients with dendritic ulcers. Clinical resolution at day seven was achieved in 72 percent (41/57) for Zirgan versus 69 percent (34/49) for acyclovir.

Sirion anticipates Zirgan will be commercially available to U.S. physicians in early 2010.

 

Interim Results for Alimera's DME Insert, Iluvien

Alimera Sciences reported the 18-month safety and efficacy results from the pharmacokinetic study of Iluvien, an investigative, extended-release intravitreal insert. The 36-month, open-label, Phase II study, running concurrently with the pivotal Phase III FAME study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of FA after administration of Iluvien in patients with DME.
Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK Study, 20 patients on the low dose of Iluvien (about 0.23 µg per day), and 17 patients on the high dose (an approximate 0.45 µg per day).

In the 18-month readout, data from the subgroup of patients that reflect the same visual acuity inclusion criteria as that of the larger FAME trial (FAME subgroup) demonstrated that 55 percent of the high-dose patients had an improvement in best-corrected visual acuity of 10 letters or greater from baseline, and 36 percent of the high-dose patients improved 15 letters or greater over baseline.

Among the low-dose patients in the FAME subgroup, 23 percent had an improvement in BCVA of 10 letters or greater from baseline while no patients showed an improvement in BCVA of 15 letters or greater from baseline at this time point.

From a safety perspective, no patients receiving the low dose of Iluvien experienced intraocular pressure increases of 30 mmHg or greater at any time point, while 29 percent of the patients receiving the high dose of Iluvien experienced IOP increases of 30 mmHg or greater at some time point.