Azasite (Azithromycin Ophthalmic) - Summary

AZASITE SUMMARY

AZASITE^® (azithromycin ophthalmic solution) 1%
Sterile topical ophthalmic drops

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite^® (polycarbophil, edetate disodium, sodium chloride).

AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

• CDC coryneform group G^*
• Haemophilus influenzae
• Staphylococcus aureus
• Streptococcus mitis group
• Streptococcus pneumoniae

^*Efficacy for this organism was studied in fewer than 10 infections.

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NEWS HIGHLIGHTS

Media Articles Related to Azasite (Azithromycin Ophthalmic)

Inspire Completes Patient Enrollment In Three Late-Stage Clinical Trials In Cystic Fibrosis, Dry Eye And Blepharitis
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.05]
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today patient enrollment is complete in three of its late-stage clinical trials. "We are pleased to be executing on our strategic plan with the achievement of these patient enrollment milestones in the clinical development programs for denufosol, PROLACRIA™ and AZASITE®, as this places us in a position to have top-line results from all our late-stage clinical programs within 18 months.

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Published Studies Related to Azasite (Azithromycin Ophthalmic)

Randomized trial of high dose azithromycin compared to standard dosing for children with severe trachoma in Tanzania. [2009.05]
BACKGROUND: Children with a heavy load of C. trachomatis infection may continue to be infected following a single dose of 20 mg/kg of azithromycin. We compared the C. trachomatis infection rates at six weeks post-treatment of children randomized to 30 mg/kg single dose of azithromycin versus 20 mg/kg single dose of azithromycin... CONCLUSION: Increasing the single dose of azithromycin to 30 mg/kg in children with severe trachoma did not result in significantly less infection at six weeks post-treatment compared to 20 mg/kg.

Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. [2008.11]
BACKGROUND: Effective ocular tissue concentrations and prolonged residence times of antibacterial agents are important in treating both acute and chronic diseases. Conjunctival biopsy allows the determination of specific tissue concentration data for topical ophthalmic agents. Drug concentration analysis at various time points following instillation allows interpretation of the residence time and a rationale for dosing frequency. OBJECTIVE: This study compared the pharmacokinetic parameters of 2 currently available topical ocular antibiotics-azithromycin ophthalmic solution 1% and moxifloxacin ophthalmic solution 0.5%-in the conjunctiva of healthy volunteers after a single topical administration... CONCLUSIONS: In this single-dose study of 2 currently available topical ocular antibiotics in healthy volunteers, therapeutic concentrations were achieved with both agents. Both treatments were well tolerated in the population studied. Clinical Trials Identification Number: NCT00564447.

Microbiological efficacy of 3-day treatment with azithromycin 1.5% eye-drops for purulent bacterial conjunctivitis. [2008.11]
PURPOSE. Antibacterial efficacy of topically applied azithromycin 1.5% was compared with tobramycin 0.3% in a multicenter, randomized, investigator-masked study for the treatment of purulent bacterial conjunctivitis... This new anti-infective product has the advantage of a short treatment course which could lead to an improvement in patient compliance.

Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. [2008.06]
PURPOSE: To analyze the effect of azithromycin 1% ophthalmic solution in DuraSite (InSite Vision, Inc, Alameda, California, USA) on bacterial conjunctivitis. DESIGN: Prospective, randomized, vehicle-controlled, parallel-group, double-masked multicenter clinical study... CONCLUSIONS: Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis.

Tear concentrations of azithromycin following topical administration of a single dose of azithromycin 0.5%, 1.0%, and 1.5% eyedrops (T1225) in healthy volunteers. [2008.01]
PURPOSE: To evaluate azithromycin tear concentrations after one drop of T1225 0.5%, 1.0%, and 1.5% eyedrops... CONCLUSIONS: Once daily instillation of T1225 1.0% and 1.5% was shown to reach an AUIC markedly above the required threshold for an antibacterial activity against Gram-positive bacteria (25-35). These results suggest that a BID instillation is more likely to ensure antimicrobial activity against Gram-negative bacteria (threshold >100).

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Clinical Trials Related to Azasite (Azithromycin Ophthalmic)

Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis [Recruiting]

Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis [Not yet recruiting]

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole) [Recruiting]
This study will look at the safety, effectiveness, and tolerability of combination medications for the initial treatment of non-gonococcal urethritis (NGU). NGU is inflammation of the tube that carries urine from the bladder. NGU is caused by bacteria that may be passed from person to person during sex. This study will compare the 2 currently recommended NGU treatments, doxycycline and azithromycin, taken with tinidazole (another medication to treat certain sexually transmitted infections). Tinidazole used with doxycycline or azithromycin may cure NGU better than when doxycycline or azithromycin is used alone. Study participants will be 300 men ages 16-45 years with NGU attending sexually transmitted disease clinics in Birmingham, AL; New Orleans, LA; Durham, NC; and Baltimore, MD. Study participation will last 7 weeks and involve 3 visits. At each visit, participants will provide a urine sample, have 2 urethral swabs, and have their urethra checked for discharge indicating infection.

Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan) [Not yet recruiting]

Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media [Not yet recruiting]
Following a single dose of azithromycin 60 mg/kg extended release formulation, pediatric subjects with acute otitis media will have similar azithromycin AUC compared with subjects taken 30 mg/kg immediate release formulation

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