Precis: NCX 470 0.042% and 0.065% were statistically superior in intraocular pressure (IOP) lowering to latanoprost 0.005%, and NCX 470 0.021% was noninferior. All NCX 470 concentrations were safe and well tolerated. Purpose: The purpose of this study was to compare varying concentrations of NCX 470 (a nitric oxide-donating bimatoprost) to latanoprost in a dose-response safety and efficacy trial. Patients and Methods: Adult patients with bilateral open-angle glaucoma or ocular hypertension were randomized to NCX 470 0.021% (n=111), 0.042% (n=108), 0.065% (n=107), or latanoprost 0.005% (n=107) once daily in the evening. IOP was measured at 8:00 am, 10:00 am, and 4:00 pm at weeks 1, 2, and 4. The primary efficacy endpoint was the reduction from baseline in mean diurnal IOP at week 4. Secondary efficacy endpoints included reductions from baseline in mean diurnal IOP at weeks 1 and 2, and reductions from baseline in time-matched IOP at 8:00 am, 10:00 am, and 4:00 pm at weeks 1, 2, and 4. Adverse events were evaluated. Results: All concentrations of NCX 470 resulted in significant reductions of mean diurnal IOP. The 0.042% and 0.065% concentrations were statistically superior to latanoprost 0.005%, and 0.021% was noninferior to latanoprost for change from baseline in mean diurnal IOP at week 4. The 0.065% concentration was also superior to latanoprost by up to 1.4 mm Hg for reduction from baseline at 8:00 am, 10:00 am, and 4:00 pm at week 4. NCX 470 was safe and well tolerated; conjunctival hyperemia was the most frequently reported adverse event. Conclusions: NCX 470 demonstrated dose-dependent reductions in IOP. The 0.042% and 0.065% concentrations demonstrated significantly greater reductions from baseline in mean diurnal IOP than latanoprost 0.005% at week 4, suggesting that higher concentrations may show even greater efficacy.

In patients with ocular hypertension or glaucoma, all treatments aim to lower intraocular pressure (IOP) by modulating aqueous humour (AH) production and/or uveoscleral and trabecular meshwork/Schlemm's canal AH drainage. PG analogues are considered to be the ‘gold standard’ treatment and are the most frequently used IOP‐lowering agents. Recent data support an important role for NO in regulating IOP. Thus, novel PG analogues carrying a NO‐donating moiety were recently advanced. Latanoprostene bunod (LBN) and NCX 470, NO‐donating derivatives of latanoprost and bimatoprost, respectively, are examples of such compounds. LBN ophthalmic solution, 0.024% (Vyzulta™), showed greater IOP‐lowering efficacy compared with that of Xalatan® (latanoprost ophthalmic solution, 0.005%) or 0.5% timolol maleate in clinical settings. NCX 470 was found to be more effective than bimatoprost in animal models of ocular hypertension and glaucoma. Selective EP2 receptor agonists (i.e. taprenepag isopropyl, omidenepag isopropyl and aganepag isopropyl) and non‐selective prostanoid receptor agonists (i.e. ONO‐9054, sepetaprost isopropyl) that concomitantly stimulate FP and EP3 receptors have also been shown to hold promise as effective IOP‐lowering agents.

Purpose ADVISE is an epidemiological, prospective, multicentric, open study to assess the characteristics and frequency of adenoviral conjunctivitis (AC) as diagnosed with the point of care AdenoPlus® test in patients suffering from acute conjunctivitis in 5 EU countries (F, It, Ger, UK, Sp). Methods Bacterial or viral conjunctivitis are usually self-limiting but some viral cases may cause persistent disease and significant morbidity. AC causes more severe disease, is extremely contagious (transmission rate 10-50%), of longer duration than bacterial (shed for 14-16 days, signs and symptoms last 2-3 weeks) and may lead to decreased visual acuity or light sensitivity from persistent subepithelial infiltrates, chronic dry eye, and visual loss from conjunctival scarring. Results AdenoPlus® is a single use, rapid (10 min.) immunoassay test for the qualitative in-vitro detection of Adenoviral hexon protein antigens directly from human eye fluid. It is a CE marked, point-of-care medical device intended for health professional use as an aid in the rapid differential diagnosis of acute conjunctivitis. Study objectives are to assess the % of patients with acute conjunctivitis who have AC, the clinical profiles associated with positive and negative tests, the correlation between the initial clinical diagnosis and the final diagnosis (post-test), the AC seasonality and geographic distribution, and to collect pharmacoeconomic data (before/after test prescribed treatments, work/school absenteeism…). Conclusion Enrollment started in June 2013 in France and in January 2014 in Germany. Italian, Spanish and UK sites will start recruiting Q2-Q3/2014. Approximately 2500 patients are expected across EU, 500 patients from 15-20 sites per country (20-30 patients per site). The first interim study results will be presented with data analyses from at least 400 patients recruited in EU.