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Introduction: A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy. Methods: Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored. Results: Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p < 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p < 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p < 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p < 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period. Conclusion: In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.

The authors would like to acknowledge missing data for all prior latanoprost users as a whole. The following sentence has been added to the manuscript (page 8, first paragraph): Mean (SD) reduction from baseline at Month 6 for users of all latanoprost formulations (preserved and PF) was 6.1 (4.25) mmHg (25.9%; p\0.0001). The authors have also prepared a table to summarise the change in intraocular pressure following a switch to the preservative-free tafluprost/timolol fixed-dose combination from all latanoprost formulations (preserved and preservative-free formulations). See Table 1 below.(Table Preseneted.) .The original article has been corrected.

Introduction: The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy. Methods: A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6. Results: The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p

The EFSA Panelon Plant Health performed a pest categorisation of Palm lethal yellowing phytoplasmas for the EU territory. This name is used to describe diseases that share the same succession of symptoms in palms that are caused by a number of strains of phytoplasma, for which efficient molecular detection assays are available. The pest is not known to occur in the EU and therefore does not meet one of the criteria for being a Union regulated non-quarantine pest. For Candidatus Phytoplasma palmae', the planthopper Haplaxius crudus, which is not known to be present in the EU, is the confirmed vector, but for the other strains, the vectors are unknown. The host range of the pest is restricted to Arecaceae species, in particular coconut. The pest is regulated on all known hosts in Annex IIAI of Directive 2000/29/EC. It could potentially enter the EU via plants for planting or through infected vectors. The phytoplasmas could become established in the EU as host plants are present. It is unknown whether arthropods present in the EU could be vectors. The potential impact of the pest if introduced into the EU is difficult to assess given this uncertainty but is estimated to be limited. The main knowledge gaps concern the status of potential vector insects in the EU; the possibility for seed transmission of the phytoplasmas; the origin and volume of the trade in palm seeds and plants for planting; the host status and susceptibility of many palm species grown in the EU and the potential new assignments of phytoplasmas to this categorisation that might have associated alternate hosts. Palm lethal yellowing phytoplasmas meet the criteria assessed by EFSA for consideration as Union quarantine pest. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

The EFSA Panel on Plant Health performed a pest categorisation of non‐EU isolates of Beet curly top virus (BCTV) for the European Union territory. The virus causes severe diseases in beet, tomatoes and pepper crops, occurs predominantly in warm and dry zones and is reported from many countries outside the EU in particular from western USA and Mexico. New data from complete virus genomes make BCTV a well characterised virus species of which currently 11 strains are known and for which diagnostic methods are available. BCTV has a very broad host range of more than 300 species some of which may remain symptomless. Aside from vegetative propagation of infected plants, the only mode of BCTV transmission and spread is by the leafhopper Circulifer tenellus which efficiently transmits the virus in a persistent mode and which is present in several southern EU Member States. No current reports of BCTV presence in the EU exist and because of doubts about the accuracy of older reports, BCTV likely is absent from the EU territory. BCTV can enter into the EU with viruliferous insects and with imports of plants not subject to specific EU regulation. Because both the virus and its vector have a wide host range, BCTV is expected to establish and spread in the Member States where its vector is present and to cause severe diseases in sugar beet and tomato as well as in other crops. Overall, BCTV non‐EU isolates meet all the criteria evaluated by EFSA to qualify as a Union quarantine pest and do not meet the criterion of presence in the EU to qualify as a Union regulated non‐quarantine pest (RNQP). The main uncertainties concern (1) the presence of BCTV in the EU, (2) the distribution of C. tenellus and (3) the main commodities for virus entry.

Following a request from the European Commission, the EFSA Panel on Plant Health (PLH) performed a quantitative analysis of the risk posed by the Flavescence doree phytoplasma (FDp) in the EU territory. Three scenarios were analysed, one with current measures in place (scenario A0), one designed to improve grapevine propagation material phytosanitary status (scenario A1) and one with reinforced eradication and containment (scenario A2). The potential for entry is limited, FDp being almost non-existent outside the EU. FDp and its major vector, Scaphoideus titanus, have already established over large parts of the EU and have the potential to establish in a large fraction of the currently unaffected EU territory. With the current measures in place (A0), spread of FDp is predicted to continue with a progression of between a few and ca 20 newly infested NUTS 2 regions during the next 10 years, illustrating the limitations of the current control measures against spread. FDp spread is predicted to be roughly similar between scenarios A1 and A2, but more restricted than under scenario A0. However, even with reinforced control scenarios, stabilisation or reduction in the number of infested NUTS 2 regions has only relatively low probability. Under scenario A0, FDp has a 0.5–1% impact on the overall EU grapes and wine production, reflecting the effectiveness of the current control measures against impact. Under both scenarios A1 and A2, FDp impact is predicted to be reduced, by approximately one-third (A1) to two-thirds (A2) as compared to A0, but the associated uncertainties are large. The generalised use of hot water treatment for planting material produced in infected zones has the most important contribution to FDp impact reduction in scenario A1 and has high feasibility. Both increased eradication and containment measures contribute to impact reduction under scenario A2 but the overall feasibility is lower.