Sustained and high concentrations were encountered with 7-day approved administration of 1% azithromycin formulation (AzaSite, Inspire Pharmaceuticals, Inc., Durham, NC) within all ocular surface tissues, particularly the lids. Many ocular surface disorders involving the tear film, eyelids, and adnexal structures are associated with chronic, low-grade bacterial infection and may potentially lead to decreased vision secondary to corneal scarring. Various topical antibiotic and steroid combinations with or without oral tetracyclines are commonly used with variable clinical response and known potential side effects. The clinical relevance of this study is unknown; however, the long-lasting antibacterial and additional anti-inflammatory properties of topical azithromycin might offer an effective alternative treatment option and should be explored further in clinical studies.

ENV905 was well tolerated and demonstrated a robust reduction in ocular inflammation with targeted drug delivery. The results from these studies show that ENV905 provides a sustained therapeutic effect after a single dose. By resolving low patient compliance and eliminating the peaks and troughs in drug concentration, sustained drug delivery via ENV905 may further improve the overall control of postoperative inflammation and pain.

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1Denufosol tetrasodium (INS37217, denufosol) is a P2Y receptor-mediated chloride channel activator in Phase 3 development Rationale:2 for the treatment of cystic fibrosis (CF) lung disease. This study was performed to assess the effect of denufosol on background inflammation in the lung following chronic inhalation in rats and dogs at doses intended to exceed the human clinical dose. Methods: Denufosol was administered as an isotonic, aerosol formulation using Pari eFlow nebulizers. Aerosol particle size was monitored, and denufosol concentration, respiratory minute volume, daily exposure time, and lung weight at necropsy were used to calculate daily pulmonary-deposited dose. Rats were treated daily for 2 years at doses up to 2.36 mg/g lung weight/day; dogs were treated daily for 1 year at doses up to 7.27 mg/g lung weight/day. Control animals were treated with nebulized isotonic saline. Bronchial alveolar lavage fluid and/or plasma denufosol levels were determined to verify exposure. The potential for denufosol to induce inflammatory responses in respiratory tract tissues was assessed histopathologically by board-certified veterinary pathologists.Rats and dogs treated with Results: saline exhibited a variety of background inflammatory lesions in the lung, including macrophage accumulation, inflammatory cell infiltration, interstitial inflammation and edema. No increase in background inflammation was observed in denufosol-treated animals when compared to placebo in either species up to the highest doses tested (6 to 18 times the human dose to children normalized to lung weight).These results demonstrate that denufosol does not increase background levels of pulmonary inflammation when Conclusion: compared to placebo following chronic inhalation in rats and dogs at significant multiples above the human clinical dose under investigation for the treatment of CF lung disease. This abstract is funded by: Inspire Pharmaceuticals, Inc. Am J Respir Crit Care Med