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Dry eye disease (DED) is one of the most common ocular surface disorders. All DED involves an imbalance between tear production and evaporation. Most cases of DED are driven by excessive evaporation, which is often associated with meibomian gland dysfunction (MGD). In evaporative DED, a deficient tear film lipid layer is believed to lead to increased tear evaporation, inflammation, and ocular surface damage. Most prescription treatments for DED address signs and symptoms by targeting tear production and/or inflammation, but they do not address excessive evaporation. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb) is a water-free, single-ingredient, preservative-free prescription eye drop that directly targets tear evaporation and is approved by the FDA to treat the signs and symptoms of DED. Results from preclinical studies indicate that PFHO has a high oxygen carrying capacity, may reduce friction on blinking, and spreads quickly over the tear film surface to form a monolayer that inhibits evaporation. These effects can lead to stabilization of the tear film to promote ocular surface healing. Further, PFHO was detected in tears for at least 6 hours in a rabbit pharmacokinetic study, and results indicate that it may improve lipid layer thickness and quality. In 2 pivotal phase 3 trials in patients with DED and clinical signs of MGD (GOBI [NCT04139798] and MOJAVE [NCT04567329]), treatment with PFHO consistently met primary efficacy end points related to DED signs and symptoms (total corneal fluorescein staining and eye dryness, respectively) and was well tolerated. Compared with use of hypotonic saline solution, instillation of PFHO led to significant improvements in signs and symptoms in as early as 2 weeks. In a long-term, open-label safety extension study, efficacy of PFHO was sustained over 12 months, and the safety profile was consistent with those of previous studies. Clinical trial results indicate that treatment with PFHO effectively and consistently reduces the signs and symptoms of DED.Dry eye disease (DED) is one of the most common ocular surface disorders. All DED involves an imbalance between tear production and evaporation. Most cases of DED are driven by excessive evaporation, which is often associated with meibomian gland dysfunction (MGD). In evaporative DED, a deficient tear film lipid layer is believed to lead to increased tear evaporation, inflammation, and ocular surface damage. Most prescription treatments for DED address signs and symptoms by targeting tear production and/or inflammation, but they do not address excessive evaporation. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb) is a water-free, single-ingredient, preservative-free prescription eye drop that directly targets tear evaporation and is approved by the FDA to treat the signs and symptoms of DED. Results from preclinical studies indicate that PFHO has a high oxygen carrying capacity, may reduce friction on blinking, and spreads quickly over the tear film surface to form a monolayer that inhibits evaporation. These effects can lead to stabilization of the tear film to promote ocular surface healing. Further, PFHO was detected in tears for at least 6 hours in a rabbit pharmacokinetic study, and results indicate that it may improve lipid layer thickness and quality. In 2 pivotal phase 3 trials in patients with DED and clinical signs of MGD (GOBI [NCT04139798] and MOJAVE [NCT04567329]), treatment with PFHO consistently met primary efficacy end points related to DED signs and symptoms (total corneal fluorescein staining and eye dryness, respectively) and was well tolerated. Compared with use of hypotonic saline solution, instillation of PFHO led to significant improvements in signs and symptoms in as early as 2 weeks. In a long-term, open-label safety extension study, efficacy of PFHO was sustained over 12 months, and the safety profile was consistent with those of previous studies. Clinical trial results indicate that treatment with PFHO effectively and consistently reduces the signs and symptoms of DED.

Conjunctivitis, or inflammation of the conjunctiva, refers to a diverse group of ocular surface diseases of viral or bacterial origin that primarily affect the conjunctiva. In developed countries, the most common causative bacterial pathogens are Staphylococcus aureus, Haemophilus influenzae, and Streptococcus pneumoniae. Most varieties of conjunctivitis are self-limiting; however, some cases can be extremely contagious or cause serious complications if left unchecked. New ocular antibiotics are needed to keep pace with the increasing incidence of bacterial resistance and provide options that decrease the overall treatment burden and encourage patient compliance. Azithromycin is a well known systemic anti-infective with broad spectrum activity against gram positive-, gram negative-, and atypical bacteria species. Ocular use has been limited because its solubility and stability profiles in aqueous media were not favorable for delivery to the eye. An eyedrop of 1% azithromycin in DuraSite((R)) (AzaSite, InSite Vision, Alameda, CA, USA), a bioadhesive ocular drug delivery system, was recently developed and evaluated in clinical trials. This formulation is well tolerated, delivers a high concentration of azithromycin to the conjunctiva, has a broader eradication profile than aqueous azithromycin, and can be effectively dosed with 7 drops, a 65% reduction in the amount of drops required by the most popular antibiotics currently used for conjunctivitis.

Conjunctivitis, or inflammation of the conjunctiva, refers to a diverse group of ocular surface diseases of viral or bacterial origin that primarily affect the conjunctiva. In developed countries, the most common causative bacterial pathogens are Staphylococcus aureus, Haemophilus influenzae, and Streptococcus pneumoniae. Most varieties of conjunctivitis are self-limiting; however, some cases can be extremely contagious or cause serious complications if left unchecked. New ocular antibiotics are needed to keep pace with the increasing incidence of bacterial resistance and provide options that decrease the overall treatment burden and encourage patient compliance. Azithromycin is a well known systemic anti-infective with broad spectrum activity against gram positive-, gram negative-, and atypical bacteria species. Ocular use has been limited because its solubility and stability profiles in aqueous media were not favorable for delivery to the eye. An eyedrop of 1% azithromycin in DuraSite super(ARG) (AzaSiteac, InSite Vision, Alameda, CA, USA), a bioadhesive ocular drug delivery system, was recently developed and evaluated in clinical trials. This formulation is well tolerated, delivers a high concentration of azithromycin to the conjunctiva, has a broader eradication profile than aqueous azithromycin, and can be effectively dosed with 7 drops, a 65% reduction in the amount of drops required by the most popular antibiotics currently used for conjunctivitis.

Strabismus has been known to have a significant genetic component, but the mode of inheritance and the identity of the relevant genes have been enigmatic. This paper reports linkage analysis of nonsyndromic strabismus. The principal results of this study are: (i) the demonstrated feasibility of identifying and recruiting large families in which multiple members have (or had) strabismus; (ii) the linkage in one large family of a presumptive strabismus susceptibility locus to 7p22.1 with a multipoint logarithm of odds score of 4.51 under a model of recessive inheritance; and (iii) the failure to observe significant linkage to 7p in six other multiplex families, consistent with genetic heterogeneity among families. These findings suggest that it will be possible to localize and ultimately identify strabismus susceptibility genes by linkage analysis and mutation screening of candidate genes.

The study was designed to evaluate the efficacy of an ophthalmic formulation of 1% azithromycin in DuraSite((R)) (AzaSite, InSite Vision, Alameda CA, USA) and demonstrate equivalence with 0.3% tobramycin ophthalmic solution, USP, for the treatment of bacterial conjunctivitis as defined by the resolution of clinical signs and the eradication of pathogens. Prospective, randomized, active-controlled, double-masked, phase 3 trial conducted at 47 US sites between 6 August 2004 and 6 October 2005. Subjects aged 1 year or older with diagnosis of acute bacterial conjunctivitis. Bacteriologically confirmed participants received either 1% azithromycin in Dura-Site (n = 159) or tobramycin (n = 157). Masked study medications were dosed 4 times a day for 5 days. Participants in the 1% azithromycin in DuraSite group were dosed twice a day with active drug on days 1 and 2 and once daily on days 3 through 5. The other doses were vehicle. Clinical signs and bacterial cultures were evaluated at visit 3 (day 6 + 1). Clinical resolution was observed in 79.9% of participants in the 1% azithromycin in DuraSite group, as compared with 78.3% of those in the tobramycin group (95% CI: -7.4-10.5). Bacterial eradication was 88.1% in the 1% azithromycin in DuraSite group vs 94.3% in the tobramycin group (95% CI: -12.4-0.0). Analyses of resistance confirmed that 1% azithromycin in DuraSite eradicated Staphylococci and Streptococci strains that are commonly resistant to azithromycin, erythromycin, and fluoroquinolones. The efficacy of 1% azithromycin in DuraSite and tobramycin are equivalent; however, this formulation of azithromycin also permits effective dosing intervals of twice a day on days 1 and 2 followed by once daily on the last 3 days of therapy, for a total of 65% fewer doses. In vitro, the killing spectrum of 1% azithromycin in DuraSite appears to be enhanced relative to 1% azithromycin without DuraSite.

Steven J Lichtenstein1, David B Granet21Associate Clinical Professor of Pediatrics and Surgery, University of Illinois College of Medicine at Peoria and Chicago, Peoria, IL, USA, 2Anne F. Ratner Professor of Ophthalmology and Pediatrics, University of California at San Diego, San Diego, CA, USAIn a recent issue of Clinical Ophthalmology, Friedlaender and Protzko (2007) review the development and efficacy of 1% azithromycin in DuraSite® (AzaSite™, Inspire Pharmaceuticals, Inc., Durham, NC) for the treatment of bacterial conjunctivitis. The authors conclude that 1% azithromycin in DuraSite offers a simplified dosing regimen with sustained bactericidal levels that decrease resistance development. While 1% azithromycin in DuraSite is a new formulation of azithromycin that allows topical ocular use, azithromycin and DuraSite have been around for many years. Evidence demonstrates a greater potential for emerging resistance with azithromycin, an older drug, especially when formulated in a vehicle that prolongs low levels of antibiotic exposure over time. Mitchell H Friedlaender1, Eugene Protzko21Division of Ophthalmology, Scripps Clinic, 10666 N Torrey Pines Rd, La Jolla, CA, 92037 USA; 2Seidenberg Protzko Eye Associates, 930 Revolution St, Havre De Grace, MD, 21014 USAIn our review of the development and efficacy of 1% azithromycin in DuraSite® (AzaSite™, InSite Vision, Alameda, CA, USA) published in Clinical Ophthalmology (Friedlaender and Protzko 2007), we describe azithromycin as a well known anti-infective agent with pharmacokinetic properties that were not sufficiently exploited for topical use in the eye until the development of AzaSite. A sustained release ocular antibiotic, AzaSite delivers sufficiently high concentrations of azithromycin to the eye to eradicate common causative pathogens of bacterial conjunctivitis. The means by which azithromycin is delivered to the eye in the AzaSite formulation gives it much greater tissue concentrations than expected.