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Conjunctivitis treatment also improves signs, symptoms of blepharitis
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A macrolide antibiotic drop approved for treating bacterial infection has also shown efficacy in treating blepharitis. Clinical trials and clinical practice suggest that AzaSite (azithromycin, Inspire) addresses the signs and symptoms associated with lid margin disease.
When treating blepharitis, it is important to manage all aspects of the disease, according to Paul Karpecki, OD, FAAO, a member of the Primary Care Optometry News Editorial Board. Hot compresses are especially important, he said. “However, there’s no doubt there’s both a bacterial component and — even more significantly — an inflammatory component,” he said in an interview with PCON. “It seems that AzaSite, which addresses both, tends to work well.”
Study results
To confirm doctors’ observations of AzaSite as a treatment for lid disease, several small pilot studies have looked at AzaSite’s efficacy in treating blepharitis. In both studies, AzaSite delivered significant results in reducing the signs and symptoms of the disease.
In a 2-week pilot study sponsored by Inspire and conducted by Jodi Luchs, MD, 21 patients were instructed to use warm compress therapy twice a day for 5 to 10 minutes. Ten of the 21 patients were instructed to use 1 drop of AzaSite twice a day for the first 2 days and once daily for the next 12 days.
At the conclusion of this 2-week phase 4 clinical trial, statistically significant improvement was seen with AzaSite in combination with warm compresses vs. warm compresses alone in several blepharitis signs and symptoms including lid margin hyperemia, extent of meibomian gland plugging and quality of meibomian gland secretions. Forty-four percent of patients treated with AzaSite had complete resolution of meibomian gland plugging in at least one eye as compared to no patients who used warm compress therapy alone.
In a 4-week pilot study of 26 patients sponsored by Inspire and conducted by Ophthalmic Research Associates, AzaSite was used without the addition of warm compresses. Results were compared to baseline. AzaSite showed statistically significant improvement after 4 weeks of treatment.
According to Inspire Pharmaceuticals’ Felix Dover, PharmD, “The difference in reduction of the signs and symptoms between the two studies may show the importance of using warm compresses on a consistant basis.
“What we’ve seen in the initial trials is that drug alone has some effect on the meibomian gland secretions,” Dr. Dover told PCON. “However, once they’re plugged, the addition of moist heat really helps melt the plugs and speed up the entire process.”
Thomas John, MD, and Ami A. Shah, BS, MBB, also conducted a study that was presented during the European Society of Cataract and Refractive Surgery Meeting in September. In this study, 75 patients with chronic mixed anterior blepharitis were treated with azithromycin or erythromycin. The researchers instructed the 67 patients using AzaSite to apply it to a clean index finger or applicator and apply the medication directly to the eyelids of both eyes rather than to the ocular surface. The eight patients using erythromycin used it according to label directions.
After 4 weeks, 98.5% of patients in the AzaSite group reported total clinical resolution as compared to 37.5% of the patients in the erythromycin group. After 8 weeks, the success rate in the AzaSite group remained the same while 50% in the erythromycin group reported total clinical resolution.
How it works
AzaSite is a viscous antibiotic drop approved for treating bacterial conjunctivitis. Practitioners considered it for treating lid disease in conditions such as anterior and posterior blepharitis due to its active ingredient, the broad-spectrum antibiotic, azithromycin, formulated into DuraSite. According to the company, the delivery technology of DuraSite enables the mucoadhesive, gel-forming drop to persist on the ocular surface for extended periods of time.
According to Marlane J. Brown, OD, FAAO, “[AzaSite] is indicated to treat conjunctivitis caused by bacteria. We do think that some blepharitis is associated with and often confused with conjunctivitis. If we treat the lid as opposed to putting this drop right into the eye, perhaps we can control the blepharitis as well as control the bacteria that might cause the bacterial conjunctivitis,” she said in an interview.
Another reason AzaSite works so well against lid disease is because of its anti-inflammatory properties due to its classification as a macrolide.
“The anti-inflammatory effects of macrolides have been well documented in other body systems, such as the lungs,” Kelly Nichols, OD, MPH, PhD, told PCON. “As we make the jump to lid disease, there’s a lot of discussion about the inflammatory components. We’re seeing some studies come out where the use of AzaSite is beneficial in reducing some signs and symptoms of the condition,” she said.
Second line of defense
Though AzaSite has not yet been approved by the U.S. Food and Drug Administration for treating blepharitis, doctors are prescribing it as a second line of defense for patients who do not improve with the traditional methods such as lid scrubs, cleansers and warm compress therapy.
“It’s not my first choice, but it’s definitely going to be my second if patients return and they’re either not compliant with those other treatments or it’s simply not working,” Dr. Brown said. “We have a lot of patients who have blepharitis symptoms, and this is an excellent option if they’re having trouble resolving it.”
Dr. Nichols appreciates the rapid improvement in patients who want immediate results.
“From a patient management perspective, I know from my own patient experiences that they don’t like to do warm compress therapy because it may take a while before they see results,” Dr. Nichols said. “If AzaSite could aid in the process by speeding things along, that may be more beneficial in today’s society where people want fast results,” she said.
Prescribing for blepharitis
The most important thing to note when treating blepharitis with AzaSite is that it works best in conjunction with warm compress therapy and proper lid hygiene, said Dr. Nichols.
“Warm compress therapy needs to be applied to the eye to allow for the liquefaction of the oils that might be blocking the glands, and it might need to be done for longer and with more warmth than patients are currently doing in their regular routines,” she said.
After applying warm compresses, Dr. Brown suggests thoroughly massaging AzaSite into the eyelid margins. “We tell patients to wash their hands very well and then place a drop of AzaSite on their finger and massage on their lower lid where the lashes and lid connect, then also on the upper lid, and then close their eyelid and massage back and forth with the AzaSite,” she said. “I ask patients to do this twice a day after using a warm compress for the first 2 days, and then once a day — usually in the evening — until the bottle is empty.”
For more information:
- Paul M. Karpecki, OD, FAAO, is director of research in Cornea and External Disease Service for Cincinnati Eye Institute and a member of the Editorial Board of Primary Care Optometry News. He can be reached at 580 S. Loop Road, Suite 200, Edgewood, KY 41017; (859) 402-2814; fax: (859) 331-9040; e-mail: paul@karpecki.com. Dr. Karpecki is a paid consultant for Inspire.
- Felix Dover, PharmD, can be reached at Inspire Pharmaceuticals Inc. 4222 Emperor Blvd., Suite 200, Durham, NC 27703; (919) 941-9777.
- Marlane J. Brown, OD, FAAO, can be reached at Minnesota Eye Consultants, PA, 710 East 24th St., Suite 100, Minneapolis, MN 55404; (612) 813-3600; mjbrown@mneye.com. Dr. Brown has no direct financial interest in the products mentioned in this article, nor is she a paid consultant for any companies mentioned.
- Kelly Nichols, OD, MPH, PhD, is an associate professor at Ohio State University and has an NIH-funded grant on dry eye. She can be reached at the Ohio State University College of Optometry, 338 W. 10th Ave., Columbus, OH 43210; (614) 688-5381; e-mail: knichols@optometry.osu.edu. Dr. Nichols is a paid consultant for Inspire.
- AzaSite is available from Inspire Pharmaceuticals Inc., 4222 Emperor Blvd., Suite 200, Durham, NC 27703; (919) 941-9777; fax: (919) 941-9797; e-mail: info@inspirepharm.com; Web site: www.azasite.com.
References:
- Haque R. Safety and efficacy pilot study of AzaSite in subjects with blepharitis. Unpublished data.
- John T, Shah AA. Use of azithromycin ophthalmic solution in the treatment of chronic mixed anterior blepharitis. Study presented at: Inspire Summit Meeting; August 2008; Las Vegas, NV.