Purpose To 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. Methods A symposium was held in July 2013 in which a series of speakers discussed issues related to the development of reference databases for imaging devices. Results Automated 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. Conclusions The 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.

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.

Epinastine 0.05% may be useful for the treatment of seasonal allergic conjunctivitis in contact lens wearers.

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