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Study Details

Topical Azithromycin Improves Blepharitis Signs and Symptoms W.B. Trattler c , K.L. Kuhn e , R. Haque e , R.C. Zink e , K.N. Sall c and J.I. Luchs c Disclosure: Authors are: c – Consultants; e – Employees of Inspire Pharmaceuticals, Inc. Study Details . Pilot study*, open-label

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Study Details

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  1. Topical Azithromycin Improves Blepharitis Signs and SymptomsW.B. Trattlerc, K.L. Kuhne, R. Haquee, R.C. Zinke,K.N. Sallc and J.I. LuchscDisclosure:Authors are: c – Consultants; e – Employees of Inspire Pharmaceuticals, Inc.

  2. Study Details • Pilot study*, open-label • Multi-center (8 sites) • Study population: 76 patients with moderate to severe blepharitis Treatment: All patients applied warm compresses (WC) BID; patients in the AzaSite® group applied azithromycin ophthalmic solution, 1% to each eye for 4 weeks (BID days 1 & 2, then QD days 3-28) • Clinical signs and symptoms were evaluated at baseline and compared to each visit throughout the study (weeks 1, 2, 3, 4 and 6) • Lid scrubs were not allowed throughout the study and 2 weeks prior to the study initiation. *This study pertains to an off-label use of AzaSite®

  3. Inclusion Criteria Age ≥ 18 years Clinical diagnosis of moderate to severe chronic blepharitis Clinical sign/symptom severity score of at least moderate (2) severity on either eyelid margin hyperemia or eyelid swelling, or both. Clinical sign severity score of at least moderate (2) severity on either eyelid debris or plugging of the meibomian glands, or both. Have a symptom severity score of at least moderate (2) on their self-reported “most bothersome” symptom at baseline and a score of at least moderate (2) on any other symptom Best corrected visual acuity of at least +0.7 as assessed by ETDRS Exclusion Criteria Use of eyelid scrubs within 2 weeks of Visit 1 and for the duration of the study Use of mechanical therapy (warm compresses) within 2 weeks of Visit 1 Unwilling to discontinue contact lens wear for the duration of the study History of ocular surface surgical intervention within 12 months prior to the study Use of any preserved topical ophthalmic medications at entry or during the study Use of topical ocular or orally administered antibiotics within 30 days of Visit 1 and for the duration of the study Use of topical cyclosporine within 30 days of Visit 1 and for the duration of the study Use of topical ocular steroids or NSAIDS 2 weeks prior to entry or during the study Inclusion/Exclusion Criteria

  4. Warm Compresses Alone Azithromycin Ophthalmic Solution, 1% + Warm Compresses Warm Compresses Alone Day 1 Day 8±2 Day 15±2 Day 22±2 Day 29±2 Day 43±2 Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Study Design Randomization

  5. Safety and Efficacy Endpoints • Safety Measurements • Biomicroscopy and External Eye Exam • BCVA • AE monitoring • IOP • Ophthalmoscopy • Efficacy scores for the clinical signs/symptoms*: • Total Clinical Outcome Score (summation of individual signs listed below; 0-20 range) • Eyelid Debris • Eyelid Swelling • Plugging of the meibomian gland • Meibomian gland secretions • Eyelid margin hyperemia • Total Symptom Score (summation of five individual symptoms listed below; 0-20 range) • Foreign body sensation • Ocular itching • Ocular dryness • Burning/painful eyes • Swollen/heavy eyelids • “Worst symptom” (of the five individual symptoms) *scales for individual signs/symptoms range from 0= normal/none to 4=very severe/obstructed

  6. Demographics – Intent-to-Treat Population (n=34) (n=67)

  7. Total Symptom Severity Score* – Intent-to-Treat Population (2 wks off tx) *summation of five individual symptoms (foreign body sensation, ocular itching, ocular dryness, burning/painful eyes, swollen/heavy eyelids); 0-20 range

  8. Total Clinical Outcome Severity Score* – Intent-to-Treat Population (2 wks off tx) *summation of individual signs (eyelid debris, eyelid swelling, plugging of the meibomian gland, meibomian gland secretions and eyelid margin hyperemia); 0-20 range

  9. Individual Signs/Symptom Results – Intent-to-Treat Population

  10. Investigator-rated Global Assessment of Efficacy – Intent-to-Treat Population

  11. Safety Results • Generally well tolerated • 4 (11%) patients in the azithromycin in combination with WC group had at least one AE vs. 3 (8%) patients in the WC alone group. • The incidence of ocular AEs in the azithromycin in combination with WC group was 2 (5%) vs 1 (3%) patients in the WC alone group.

  12. Conclusions • The results of this study indicate that Azithromycin ophthalmic solution, 1% in combination with warm compresses provides significant improvement over warm compresses alone in treating the signs and symptoms of blepharitis. • The effect of Azithromycin ophthalmic solution appears to be rapid and is frequently observed after the first or second week of treatment for symptoms and investigator global assessments. • The safety profile observed in this study is similar to that observed in the registration studies of Azithromycin ophthalmic solution, 1% for the treatment of bacterial conjunctivitis

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