March 10, 2011
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Study: Antibiotic resolves subjective, objective signs of blepharitis at 4 weeks

Significant improvement continued 2 weeks after treatment for eyelid margin redness, palpebral conjunctival redness and ocular discharge.

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A 4-week course of azithromycin treated blepharitis without the aid of auxiliary treatment, according to a study.

“Azithromycin provided significant improvement in signs and symptoms of blepharitis after 4 weeks of treatment compared with baseline and persisted in the 4-week follow-up period,” the study authors said in Cornea.

The multicenter, open-label pilot study included 26 patients with a mean age of 64.2 years who had moderate to severe blepharitis and received azithromycin 1% without warm compresses or eyelid scrubs for 28 days. The treatment regimen was twice daily on days 1 and 2 and once daily on days 3 to 28.

“The results of this study are clinically significant, as this was the first study to assess the use of topical azithromycin in patients with moderate to severe blepharitis as a stand-alone treatment,” study author Reza Haque, MD, PhD, vice president of Clinical Ophthalmology and Clinical Affairs for Inspire Pharmaceuticals, told Ocular Surgery News.

Investigators evaluated the effect of azithromycin on tear cytokine levels, eyelid margin bacterial load, and ocular clinical sign and symptom scores. Blepharitis signs and symptoms at baseline, end of treatment on day 29, and at follow-up visits 2 and 4 weeks after treatment were examined. Investigators obtained eyelid bacterial cultures and measured tear cytokines.

Study data showed statistically significant reductions in meibomian gland plugging, eyelid margin redness, palpebral conjunctival redness and ocular discharge between baseline and day 29. Significant improvement continued 2 weeks after treatment for margin redness, palpebral conjunctival redness and ocular discharge.

Subjective patient-reported symptoms of lid itching, foreign body sensation, ocular dryness, burning or pain, and swollen or heavy lids also showed statistically significant decreases (P < .001 for all symptoms at all intervals and P = .037 for ocular dryness at the fourth visit). Symptomatic improvement was maintained throughout the 4-week follow-up period.

Eyelid margin cultures showed marked decreases in bacteria including commonly isolated species of coagulase-negative staphylococci and coryneform bacteria (P = .037 and P < .001, respectively). A statistically significant increase in levels of Propionibacterium acnes was observed on day 29, the authors said.

The results of the study are consistent with previous studies that evaluated the effects of topical azithromycin in conjunction with warm compresses compared with warm compresses alone, Dr. Haque said. The addition of warm compresses in the prior study rendered an improvement in the quality of secretions.

Adverse events totaled 19 in 12 patients; 15 of the events were ocular in nature. No adverse events were deemed serious, the authors reported.

Further study is needed to determine the duration of treatment and its effect on the clinical signs of blepharitis. According to Dr. Haque, Inspire Pharmaceuticals is now exploring the developmental pathway for approval of azithromycin for the treatment of blepharitis.

“A pilot study is currently under way to evaluate the effects of topical azithromycin on the levels of inflammatory mediators in the tissue of the lid margin and conjunctiva of patients with blepharitis,” he said.

Inspire is planning to finance further studies examining the anti-inflammatory effects of azithromycin in ocular tissue as well as the properties of azithromycin that alter lipids in patients with meibomian gland dysfunction.

“We are looking forward to further exploration of the role of topical azithromycin as a potential therapy for blepharitis, a common condition which can have a large impact on surgical outcomes, contact lens intolerance and the quality of life of patients suffering from this disease,” Dr. Haque said. – by Stephanie Vasta

References:

  • Haque RM, Torkildsen GL, Brubaker K, et al. Multicenter open-label study evaluating the efficacy of azithromycin ophthalmic solution 1% on the signs and symptoms of subjects with blepharitis. Cornea. 2010;29(8):871-877.
  • Luchs J. Efficacy of topical azithromycin ophthalmic solution 1% in the treatment of posterior blepharitis. Adv Ther. 2008;25(9):858-870.

  • Reza Haque, MD, PhD, can be reached at 4222 Emperor Blvd., Suite 200, Durham, NC 27703; 919-287-1293; e-mail: rhaque@inspirepharm.com.
  • Disclosure: Dr. Haque is vice president of Clinical Ophthalmology and Clinical Affairs for Inspire Pharmaceuticals.