October 2008




A new possibility for lid margin treatment

by Vanessa Caceres EyeWorld Contributing Editor


Antibiotic for pink eye has an alternate use

Source: Inspire Pharmaceuticals

Although AzaSite (azithromycin ophthalmic solution 1%, Inspire Pharmaceuticals, Durham, N.C.) became available in the U.S. last year for treatment of bacterial conjunctivitis, a number of ophthalmologists are more interested in its role in lid margin disease and lid sterilization.

AzaSite was approved in April of last year by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial conjunctivitis, or pink eye. Azithromycin is a semi-synthetic antibiotic derived from erythromycin, which is available orally as Zithromax (Pfizer, New York, N.Y.). The drop’s consistency is a cross between an ointment and a regular drop.

Inspire launched U.S. sales of AzaSite in August of last year. Sales estimates of AzaSite this year are expected to total $30 to $45 million, according to an Inspire press release. Since its release, ophthalmologists have discovered roles for it that go beyond pink eye.

Lid margin disease

“AzaSite is a wonderful new product for ocular surface disease. It’s good for a subset of patients with meibomian gland dysfunction, blepharitis, and rosacea,” said Robert Latkany, M.D., founder and director, Dry Eye Clinic, New York Eye and Ear Infirmary, New York.

He has experimented with using AzaSite in these patients instead of oral doxycycline (various manufacturers).

Eric D. Donnenfeld, M.D., co-chairman of cornea, Nassau University Medical Center, East Meadow, N.Y., has used it for similar purposes. “It almost acts like a soft steroid. It gives the effects of an antibiotic but works as an anti-inflammatory,” he said. “The tissue penetration is so good, one drop adheres to the lid margin and achieves therapeutic levels for more than 24 hours.”

Dr. Donnenfeld’s patients use AzaSite once a day at night by rubbing it in their lid margin. He has begun to use AzaSite more frequently instead of steroids, which cannot be used long-term, and oral doxycycline, which has similar effects but doesn’t get to the same penetration levels as AzaSite.

Dr. Donnenfeld conducted an open-label evaluation of AzaSite dosed two times a day for two days and then once a day for a month. Patients had marked improvement in meibomian gland inspissation, reduction in lid erythema, and tear film stability improvement. He would like to have a controlled trial to effectively show AzaSite’s effectiveness against lid margin disease.

David Yeh, M.D., Rockville, Md., who was curious to know more about AzaSite’s use in lid margin disease, tried AzaSite with two blepharitis patients. “The results were equivocal, although I may continue to try it for this purpose,” he said.

Lid sterilization

AzaSite may also have a role in surgical lid sterilization, said J. E. “Jay” McDonald II, M.D., Fayetteville, Ark. “With all the emphasis on endophthalmitis and clear corneal incisions, we’re all sensitive to catastrophic outcomes,” Dr. McDonald said. This concern has led to his practice of injecting vancomycin (Vancocin, Eli Lilly, Indianapolis) in the stroma to seal the incision, and he is thoughtful about the potential of AzaSite to further prevent surgical-related infection.

His patients currently use lid scrubs and bacitracin ointment (various manufacturers) for three to five days before surgery and up to a week post-op. However, the ointment is unpopular with patients. “We could have a drop that patients use once a day for three days before surgery and then maybe a week after,” he said. “As it accumulates in huge concentrations in the lid, it could sterilize it.”

A study reported on Inspire’s Web site showed that AzaSite eradicated 92% of gram-negative bacteria such as Streptococcus pneumoniae, Staphylococcus aureus, CDC coryneform group G, Streptococcus mitis, Staphylococcus epidermidis; and 88% of gram-positive bacteria such as Haemophilus influenzae and Moraxella catarrhalis. It also provides coverage against some forms of atypical bacteria, including Chlamydia trachomatis and Chlamydia pneumoniae. The 289 patients in this study received AzaSite twice a day for the first two days and then one drop on days three to five.

Dr. McDonald would like to further explore this potential use within his own operating room and in formal studies.

Bacterial conjunctivitis

Ophthalmologists and pediatricians are also using AzaSite for its go-to purpose, treatment of bacterial conjunctivitis.

Patients use the drop twice a day for two days and then once a day for three more days, for a total of nine drops. The product’s Web site reports clinical improvement in 94% of bacterial conjunctivitis patients by day three and a favorable safety profile in patients at least a year old.

“It’s got a nice niche in pediatric ophthalmology because it is used once a day,” Dr. Donnenfeld said. “No one likes to take drops, least of all kids.” He has also found it helpful in treating neo-natal conjunctivitis.

Editors’ note: Dr. Donnenfeld has financial interests with Advanced Medical Optics (Santa Ana, Calif.), Alcon (Fort Worth, Texas), Allergan (Irvine, Calif.), Bausch & Lomb (Rochester, N.Y.), and Inspire Pharmaceuticals (Durham, N.C.). Dr. McDonald is a has financial interests with Alcon, Bausch & Lomb, and Inspire, among other ophthalmic companies. Drs. Latkany and Yeh have no financial interests related to their comments.

Contact Information:

Donnenfeld: 516-766-2519, eddoph@aol.com

Latkany: 212-832-2020, relief@dryeyedoctor.com

McDonald: 479-521-2555, mcdonaldje@mcdonaldeye.com.

Yeh: dyah@mac.com

A new possibility for lid margin treatment A new possibility for lid margin treatment
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