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Jose Guell,1 Anders Behndig,2 Uwe Pleyer,3 Stéphane Jaulerry,4 Pascal Rozot,5 Pierre-Jean Pisella,6 Pierre-Yves Robert,7 Ines Lanzl,8 Sayeh Pourjavan,9 Carlos Aguiar,10 Joaquin Fernandez,11 Gunther Grabner,12 Rita Mencucci,13 Frédéric Chiambaretta,14 Marc Labetoulle15 On behalf of the Intracameral Mydrane (ICMA) and Ethics Group 1Cornea and Refractive Surgery Unit, Instituto de Microcirugía Ocular, Barcelona, Spain; 2Department of Clinical Science/Ophthalmology, Umeå University Hospital, Umeå, Sweden; 3Universitäts-Augenklinik, Charité Campus Virchow-Klinik, Berlin, Germany; 4Centre Hospitalier de Bigorre, Tarbes, France; 5Clinique Monticelli, Marseille, France; 6Hôpital Bretonneau, CHRU de Tours, Tours, France; 7Hôpital Dupuytren, CHU de Limoges, Limoges, France; 8Chiemsee Augen Tagesklinik, Prien, Germany; 9Cliniques Universitaires Saint-Luc, Bruxelles, Belgium; 10Hospital de Santo Antonio, Porto, Portugal; 11Hospital Torrecárdenas, Almeria, Spain; 12Universitätsklinik Für Augenheilkunde Und Optometrie, Der Paracelsus, Austria; 13AOU Careggi, Clinica Oculistica, Università Degli Studi di Firenze, Firenze, Italy; 14Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France; 15Hôpital Bicêtre, Université Paris Sud, Paris, France Objective: The objective of this study was to compare systemic exposure to tropicamide/phenylephrine following intracameral or topical administration before cataract surgery. Patients and methods: Mydriatics exposure was calculated in patients randomized to intracameral fixed combination of mydriatics and anesthetic ([ICMA]: tropicamide 0.02%, phenylephrine 0.31%, and lidocaine 1%, N=271) or mydriatic eye drops ([EDs]: tropicamide 0.5% and phenylephrine 10%, N=283). Additional doses were permitted if required. Mydriatic plasma levels were determined by mass spectrometric HPLC in 15 patients per group before and after administration.Results: Most ICMA patients (73.6%) received a single dose (200 µL) representing an exposure to tropicamide of 0.04 mg and phenylephrine of 0.62 mg. None of these patients received additional mydriatics. In the control group (three administrations), the exposure was 0.45 (11.3-fold higher than ICMA) and 10.2 (16.5-fold higher) mg. When additional ED was used in this group (9.2% of patients), it was 37.5-fold higher for tropicamide (10 drops, 1.5 mg) and 54.8-fold higher for phenylephrine (10 drops, 34 mg) than the recommended ICMA dose. Tropicamide plasma levels were not detectable at any time point in ICMA patients while it was detectable in all ED patients at 12 and 30 minutes. Phenylephrine was detectable in 14.3% of ICMA patients compared to all ED patients at least at one time point. More ED patients experienced a meaningful increase in blood pressure and/or heart rate (11.2% vs 6.0% of ICMA patients; P=0.03).Conclusion: Systemic exposure to tropicamide/phenylephrine was lower and cardiovascular (CV) effects were less frequent with ICMA. This could be of particular significance in patients at CV risk. Keywords: cataract surgery, intracameral mydriasis, topical mydriasis, systemic influence, cardiovascular safety

Marc Labetoulle,1 Stefanie Schmickler,2 David Galarreta,3 Daniel Böhringer,4 Abayomi Ogundele,5 Michel Guillon,6 Christophe Baudouin7,8 1Ophtalmologie, Hôpital Bicêtre, APHP, South Paris Université, Kremlin-Bicêtre, Paris, France; 2Augen-Zentrum-Nordwest Augenpraxis, Ahaus, Germany; 3Hospital Clinico Universitario de Valladolid, Valladolid, Spain; 4Eye Center, University Hospital Freiburg, Freiburg, Germany; 5Novartis Pharmaceutical Corporation, Fort Worth, TX, USA; 6Ocular Technology Group, London, UK; 7Quinze-Vingts Hospital, DHU Sight Restore, University Versailles Saint Quentin en Yvelines, INSERM-DHOS CIC, Paris, France; 8Sorbonne Universités, UPMC Univ Paris 06, INSERM, CNRS, Institut de la Vision, Paris, France Background: An artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.Methods: In a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH)

Pierre-Jean Pisella,1 Marc Labetoulle,2 Serge Doan,3 Beatrice Cochener-Lamard,4 Mourad Amrane,5 Dahlia Ismail,5 Catherine Creuzot-Garcher,6,7 Christophe Baudouin8–10 1Department of Ophthalmology, Tours University Hospital, University François Rabelais, Bretonneau Hospital, Tours, 2Department of Ophthalmology, Bicêtre Hospital, APHP, Paris-Sud University, Le Kremlin-Bicêtre, 3Department of Ophthalmology, Bichat Hospital and Fondation A de Rothschild, Paris, 4Brest University Medical School, Morvan Hospital, Brest, 5Santen SAS, Evry, 6Department of Ophthalmology, University Hospital, 7Department of Ophthalmology III, Eye and Nutrition Research Group, Burgundy, Dijon, 8Research Team S12, Quinze-Vingts National Ophthalmology Hospital, 9Department of Ophthalmology, Ambroise-Paré Hospital, APHP, UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, 10University of Versailles Saint-Quentin en Yvelines, Versailles, France Purpose: The objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program. Methods: Patients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3–5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for once-daily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated. Results: The ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren’s syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events. Conclusion: The French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice. Keywords: dry eye, keratoconjunctivitis sicca, cyclosporine A, Sjögren’s syndrome, inflammation, cationic emulsion, severe keratitis, Ikervis

Dry eye disease (DED) is a common disorder, accounting for up to 35% of the general population. Therefore, we hypothesized that laryngopharyngeal reflux (LPR), inducing refluxate rising into airways, may involve the ocular surface and may either induce or worsen DED. To investigate the prevalence and relevance of suspected LPR in DED patients and subjects with refractive problems (RP) without DED, they were defined as non-dry eye group (NEG) in clinical practice. This retrospective study included consecutive patients evaluated because of dry eye-like symptoms at eight tertiary ophthalmological clinics. Parameters included reflux symptom index (RSI), ocular surface disease index (OSDI), symptom assessment in dry eye (SANDE) for frequency and severity, Schirmer test, tear break-up time (BUT), and Oxford grading. The study included 245 subjects (72.5% females; mean age 56.3 years), 152 DED patients, and 93 sex- and age-matched NEG subjects. Pathological RSI (score>13) was detected in 80 subjects (32.6%); 68 (85%) with DED and 12 (15%) CG (OR = 8; p <.0001). In NEG, pathological RSI was associated with higher SANDE (Frequency and Severity), OSDI, and Schirmer scores (OR = 16.36; 14.51; 12.54; and 7.22, respectively. In DED patients, pathological RSI was associated with higher OSDI values (OR = 8.75). Patients with DED are at eight times higher risk for having pathological RSI than NEG patients. Moreover, pathological RSI was associated with more severe ocular symptoms both in DED and non-DED patients. The role of LPR in definite DED patients remains to be clarified, but this condition deserves to be investigated in managing patients with DED symptoms. [ABSTRACT FROM AUTHOR]