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Latanoprostene bunod (LBN) ophthalmic solution 0.024% is a novel, once-daily, nitric oxide-donating prostaglandin analogue for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. The IOP-lowering actions of LBN are mediated by dual mechanisms of the molecule for increasing aqueous humour outflow. The prostaglandin analogue moiety (latanoprost acid) increases uveoscleral outflow, whereas nitric oxide, released by the nitric oxide-donating moiety (butanediol mononitrate), increases outflow through the trabecular meshwork and the Schlemm's canal. The clinical efficacy and safety of LBN 0.024% in patients with open-angle glaucoma or ocular hypertension were established in two similarly designed, double-masked, pivotal phase 3 studies, APOLLO and LUNAR, the pooled three-month efficacy phase of which demonstrated significantly greater IOP-lowering of once-daily LBN 0.024% over twice-daily timolol 0.5% at all time points. Additional support for the IOP-lowering effects of LBN 0.024% was provided by two phase 2 studies in patients with open-angle glaucoma or ocular hypertension (a dose ranging study versus latanoprost and a 24-hour IOP crossover study versus timolol) and a phase 1 study of healthy volunteers with IOP in the normal range. In addition, long-term efficacy and safety were demonstrated in the open-label safety-extension phases of the phase 3 pivotal studies and a phase 3 52-week open-label study of patients with open-angle glaucoma (including normal-tension glaucoma) or ocular hypertension. In conclusion, LBN 0.024% has demonstrated both short-term and long-term IOP-lowering efficacy in patients with open-angle glaucoma or ocular hypertension, including in healthy volunteers and patients with IOP in the normal range, without apparent clinically-limiting safety or tolerability concerns.

OBJECTIVES To assess the comfort and efficacy of epinastine 0.05% ophthalmic solution in contact lens wearers with a history of allergic conjunctivitis and contact lens intolerance during allergy season. METHODS One hundred forty-six subjects were enrolled in a multicenter, open-label study. Enrolled subjects instilled rewetting drops twice a day for a one-week run-in period, then were randomized to epinastine 0.05% twice a day plus rewetting drops as required (n = 75) or rewetting drops alone as required (minimum use twice a day) (n = 71). Subjects recorded the length of time that contact lens wear was comfortable, the total time of wear, ocular itch, overall comfort, and use of rewetting drops during the run-in period, at baseline, and on days 2 to 7 of the treatment period. RESULTS Subjects averaged 34 years of age; 79% were female. No significant differences were shown at baseline between subjects treated with epinastine 0.05% twice a day plus rewetting drops and control subjects treated with rewetting drops alone. Averaged over the treatment period, epinastine provided significant increases in comfortable wearing time (1.33 +/- 2.89 vs. 0.43 +/- 2.28 hr, P=0.012) and total wearing time (0.35 +/- 1.87 vs. -0.32 +/- 1.81 hr, P=0.008) compared with controls. Epinastine users reported less frequent additional rewetting drop use on average by 0.56 uses per day, which was significantly different than controls (reduction of 0.06 uses per day; P=0.012). Epinastine provided significantly greater improvements from baseline in ocular itch and overall eye comfort compared with rewetting drops alone (P

Author(s): Realini, Tony; Zangwill, Linda M; Flanagan, John G; Garway-Heath, David; Patella, Vincent M; Johnson, Chris A; Artes, Paul H; Gaddie, Ian B; Fingeret, Murray | Abstract: PurposeTo describe the process by which imaging devices undergo reference database development and regulatory clearance. The limitations and potential improvements of reference (normative) data sets for ophthalmic imaging devices will be discussed.MethodA symposium was held in July 2013 in which a series of speakers discussed issues related to the development of reference databases for imaging devices.ResultsAutomated imaging has become widely accepted and used in glaucoma management. The ability of such instruments to discriminate healthy from glaucomatous optic nerves, and to detect glaucomatous progression over time is limited by the quality of reference databases associated with the available commercial devices. In the absence of standardized rules governing the development of reference databases, each manufacturer's database differs in size, eligibility criteria, and ethnic make-up, among other key features.ConclusionsThe process for development of imaging reference databases may be improved by standardizing eligibility requirements and data collection protocols. Such standardization may also improve the degree to which results may be compared between commercial instruments.