DOCSLIB.ORG

NDO Home | Contact | Register for NDO Access

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
NDO Home | Contact | Register for NDO Access NNeewwsslleetttteerr Highlights of updates to NDO in November 2015 NDO home | Contact | Register for NDO access in Prescribing Regulatory changes in the EU Outlook 2015 Launched in the UK Aflibercept (Eylea) Visual impairment due to myopic choroidal neovascularisation in adults [licence extension/variation] Aviptadil + phentolamine (Invicorp) Erectile dysfunction in adult men Azacitidine (Vidaza) Acute myeloid leukaemia with more than 30% marrow blasts in patients aged 65 years or older not eligible for stem cell transplant [licence extension/variation] BLI-800 (Eziclen) Bowel cleansing Carfilzomib (Kyprolis) Multiple myeloma in adults – second-line in combination with lenalidomide and dexamethasone Ceftolozane + tazobactam (Zerbaxa) Complicated urinary tract infections in adults / Complicated intra-abdominal infections and acute pyelonephritis in adults Crizotinib (Xalkori) Advanced non-small cell lung cancer, ALK-positive in adults – first-line [licence extension/variation] Fluticasone propionate + salmeterol Chronic obstructive pulmonary disease in adults [new formulation] xinafoate (AirFluSal Forspiro) Ivacaftor (Kalydeco) Cystic fibrosis in adults who have an R117H mutation and children aged 2 to 5 years with one of nine gating mutations in CTRF gene [licence extension/variation] Leuprorelin (Prostap DCS) Precocious puberty in children [licence extension/variation] Rilpivirine (Edurant) HIV-1 infection in children aged 12 years or older [licence extension/variation] Secukinumab (Cosentyx) Ankylosing spondylitis / Psoriatic arthritis – both second-line in adults [licence extension/variation] Approved in the EU Blinatumomab (Blincyto) Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukaemia in adults Cobimetinib (Cotellic) Unresectable or metastatic melanoma with BRAF V600 mutation in adults – in combination with vemurafenib Efmoroctocog alfa (Elocta) Haemophilia A – treatment and prophylaxis of bleeding in patients of all ages Idarucizumab (Praxbind) Anticoagulation reversal in adults taking dabigatran Isavuconazole (Cresemba) Invasive aspergillosis in adults / Mucormycosis in adults unsuitable for amphotericin B Levodopa + carbidopa ER (Numient) Parkinson’s disease in adults – early-stage / late-stage [new formulation] Methoxyflurane (Penthrox) Emergency relief of moderate-to-severe pain in conscious adults with trauma and associated pain Rizatriptan (Rizaport) Migraine (not approved in UK) Sacubitril valsartan (Entresto) Symptomatic chronic heart failure with reduced ejection fraction in adults Susoctocog alfa (Obizur) Treatment of bleeding episodes in adults with acquired haemophilia caused by antibodies to Factor VIII Tenofovir alafenamide + elvitegravir + HIV-1 infection in treatment-naïve patients aged 12 years or older and weighing at cobicistat + emtricitabine (Genvoya) least 35kg [new formulation] To access New Drugs Online monographs click on the drug name/indication or visit www.ukmi.nhs.uk/ndo Direct links to abbreviated NDO monographs via NICE Evidence Search are included Complete monographs are password protected and can be viewed at www.ukmi.nhs.uk/ndo In November 2015 | 292 monographs updated | 41 evidence-based evaluations added | 5,027 registered NDO users NNeewwsslleetttteerr EU positive opinions Brivaracetam (Briviact) Partial-onset seizures – adjunctive therapy in patients aged 16 years and older Certolizumab pegol (Cimzia) Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate or other DMARDs [licence extension/variation] Etanercept biosimilar – SB4 Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis (Benepali) Pegaspargase (Oncaspar) Acute lymphoblastic leukaemia in adults and children from birth Pitolisant (Wakix) Narcolepsy, with or without cataplexy, in adults Filed for approval in the EU Abaloparatide Postmenopausal osteoporosis Alectinib (Alecensa) Non-small cell lung cancer, ALK-positive, after failed crizotinib treatment Anamorelin Anorexia/cachexia associated with non-small cell lung cancer Begelomab (Begedina) Graft versus host disease Chenodeoxycholic acid (Xenbilox) Cerebrotendinous xanthomatosis Empagliflozin + linagliptin (Glyxambi) Type 2 diabetes mellitus [new formulation] Follitropin delta (Rekovelle) Female infertility Ibrutinib (Imbruvica) Chronic lymphocytic leukaemia in newly-diagnosed, treatment-naive patients aged 65 years or older [licence extension/variation] Rituximab biosimilar – CT-P10 Rheumatoid arthritis Other EU developments Aclerastide Diabetic foot ulcer – development discontinued Encenicline Alzheimer’s disease – development suspended Gevokizumab Uveitis – development discontinued Phase in Monographs recently added to NDO (14) EU (US) ALKS8700 Multiple sclerosis None (PI) Anifrolumab Systemic lupus erythematosus PIII (PIII) Bimatoprost Glaucoma and ocular hypertension – sustained-release implant PIII (PIII) Cabotegravir HIV infection in treatment-naïve patients – in combination with rilpivirine PII (PII) CXL-1427 Acute decompensated heart failure PII (PII) Dexamethasone Meniere’s disease – intratympanic injection PII (PIII) Fluticasone propionate + salmeterol Asthma in adults and adolescents Launched - PIII UK xinafoate (AirFluSal Forspiro) (None) Idelalisib (Zydelig) Relapsed chronic lymphocytic leukaemia – in combination with PIII (PIII) ofatumumab MRX-I Acute bacterial skin and skin structure infections None (PII) Nitroglycerin (GoNitro) Angina pectoris – acute relief or prophylaxis None (Filed) Pembrolizumab (Keytruda) Colorectal cancer, microsatellite instability high metastatic None (None) Ridinilazole Clostridium difficile infection PII (None) Tavilermide Keratoconjunctivitis sicca (dry eye disease) None (PIII) Voclosporin (Voclera) Lupus nephritis PII (PII) If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo In November 2015 | 292 monographs updated | 41 evidence-based evaluations added | 5,027 registered NDO users This is an NHS document not to be used for commercial purposes .
Load more

Recommended publications
  • Social and Analysts, Join Us! @Scripnews /Scripintelligence Contents/Editor’S Letter
    November 20th 2015 No 3778 scripintelligence.com Brandicourt’s ‘Big Reveal’ Falls Flat For Sanofi Seven months into the job and the shine is wearing off Sanofi’s new CEO Olivier Brandicourt. His first “Meet the Management” investor day on Nov. 6 left analysts underwhelmed and shares slipping. Previous CEO Christopher Viehbacher’s ignominious departure last year was blamed on the poor performance of its US diabetes franchise, weak oversight of local management and poor communication with Sanofi’s board of directors. Brandicourt may feel he has made strides to tackle management Bplanet/shutterstock.com and communication issues, but the diabetes franchise continues to be problematic. “Sanofi provided a 2020 growth outlook with a disappointing near-term earnings MISSING THE TARGET: Sanofi CEO lays out plans as further diabetes trajectory – flat EPS growth to 2017 versus franchise decline looms consensus expectations of 3-5% growth,” noted Goldman Sachs. Building on a reorganization of Sanofi that Brandicourt outlined four strategic priorities 2. To deliver “outstanding” launches with a he announced in July, Brandicourt delivered for Sanofi: particular focus on six major products: a set of ambitious priorities for the French 1. To reshape its portfolio around the Toujeo (insulin glargine injection), Praluent pharma major. “The company will remain core businesses where it can sustain a (alirocumab), Dengvaxia (dengue fever diversified but with a portfolio focused on leadership position or build a competitive vaccine), sarilumab, LixiLan (lixisenatide
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • Dry Eye Disease in the 21St Century the Burden of Dry Eye Disease
    CME MONOGRAPH Two ways to request CME credit: Visit http://tinyurl.com/dryeyedisease or fax the completed form to 215-825-4732. IMproVIng rECognITIon anD ManagEMEnT of DRY EYE DISEASE IN THE 21ST CENTURY THE BURDEN OF DRY EYE DISEASE Original Release: September 1, 2016 Last Review: August 1, 2016 Expiration: September 30, 2017 FACULTY This continuing medical education activity is jointly provided by Stephen C. Pflugfelder, MD Wills Eye Hospital and MedEdicus LLC. Chair/Moderator Esen Akpek, MD Edward J. Holland, MD America’s First World’s Best Jodi Luchs, MD This continuing medical education activity is supported through an unrestricted educational grant from Shire. Victor L. Perez, MD Distributed with Purpose and Target Audience 3. Describe their role. Increasing knowledge about dry eye disease is fueling 4. no relevant financial relationships. advances in diagnostic techniques and therapeutic Disclosures modalities that may help to overcome existing problems with underrecognition and undertreatment CME Reviewer: Ralph C. Eagle Jr, MD, has no of this common disorder. The purpose of this activity relevant financial relationships with any commercial FACULTY is to update ophthalmologists on developments in interests. the understanding of dry eye immunopathology, Faculty: evaluation, and management to enable optimal Dr Esen Akpek is a consultant for novartis ag and Stephen C. Pflugfelder, MD patient care based on improved diagnosis and Shire; and a contracted researcher for allergan. treatment tailored to the individual’s disease Chair/Moderator characteristics. Dr Edward J. Holland is a consultant for alcon; professor of ophthalmology Bausch & Lomb Incorporated; Kala pharmaceuticals; This activity is intended to educate James and Margaret Elkins Chair Mati Therapeutics, Inc; prn, Inc; rapid pathogen ophthalmologists.
    [Show full text]
  • Tavilermide | Medchemexpress
    Inhibitors Product Data Sheet Tavilermide • Agonists Cat. No.: HY-17622 CAS No.: 263251-78-1 Molecular Formula: C₂₄H₃₂N₆O₁₁ • Molecular Weight: 580.54 Screening Libraries Target: Trk Receptor Pathway: Neuronal Signaling; Protein Tyrosine Kinase/RTK Storage: Powder -20°C 3 years 4°C 2 years In solvent -80°C 6 months -20°C 1 month SOLVENT & SOLUBILITY In Vitro NH4OH : 50 mg/mL (86.13 mM; ultrasonic and adjust pH to 10 with NH4OH) H2O : 2 mg/mL (3.45 mM; Need ultrasonic) Mass Solvent 1 mg 5 mg 10 mg Concentration Preparing 1 mM 1.7225 mL 8.6127 mL 17.2253 mL Stock Solutions 5 mM 0.3445 mL 1.7225 mL 3.4451 mL 10 mM 0.1723 mL 0.8613 mL 1.7225 mL Please refer to the solubility information to select the appropriate solvent. In Vivo 1. Add each solvent one by one: 50% PEG300 >> 50% saline Solubility: 25 mg/mL (43.06 mM); Suspended solution; Need ultrasonic 2. Add each solvent one by one: 0.5% CMC-Na/saline water Solubility: 10 mg/mL (17.23 mM); Suspended solution; Need ultrasonic BIOLOGICAL ACTIVITY Description Tavilermide is a selective, partial agonist of TrkA, or a nerve growth factor (NGF) mimetic. IC₅₀ & Target TrkA[1] In Vitro Tavilermide (MIM-D3) is a tyrosine kinase TrkA receptor agonist, which can be used to treat dry eye.Tavilermide is a proteolytically stable, cyclic peptidomimetic that has been shown to be a partial TrkA receptor agonist. Tavilermide demonstrates activities similar to NGF (but does not bind to the p75NTR receptor) and can potentiate the effects of suboptimal concentrations of NGF[1].
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • Reconsidering the Central Role of Mucins in Dry Eye and Ocular Surface Diseases T
    Progress in Retinal and Eye Research 71 (2019) 68–87 Contents lists available at ScienceDirect Progress in Retinal and Eye Research journal homepage: www.elsevier.com/locate/preteyeres Reconsidering the central role of mucins in dry eye and ocular surface diseases T ∗ Christophe Baudouina, ,1, Maurizio Rolandob,1, Jose M. Benitez Del Castilloc,1, Elisabeth M. Messmerd,1, Francisco C. Figueiredoe,1, Murat Irkecf,1, Gysbert Van Setteng,1, Marc Labetoulleh,1 a Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, University Versailles Saint Quentin en Yvelines, Paris, France b Ocular Surface & Dry Eye Center, ISPRE Ophthalmics, Genoa, Italy c University Complutense, Hospital Clinico San Carlos, Clinica Rementeria, Madrid, Spain d Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany e Department of Ophthalmology, Royal Victoria Infirmary and Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, UK f Department of Ophthalmology, Hacettepe Faculty of Medicine, Ankara, Turkey g St. Eriks Eye Hospital, Stockholm, Sweden h Hôpital Bicêtre, APHP, South Paris University, Ophthalmology, Le Kremlin-Bicêtre, France ARTICLE INFO ABSTRACT Keywords: Mucins are key actors in tear film quality and tear film stability. Alteration of membrane-bound mucin ex- Mucins pression on corneal and conjunctival epithelial cells and/or gel-forming mucin secretion by goblet cells (GCs) Goblet cells promotes in ocular surface diseases and dry eye disease (DED). Changes in the mucin layer may lead to enhanced Ocular surface tear evaporation eventually contributing to tear hyperosmolarity which has been associated with ocular surface Dry eye disease inflammation. Inflammatory mediators in turn may have a negative impact on GCs differentiation, proliferation, Ocular inflammation and mucin secretion.
    [Show full text]
  • The Norfolk and Waveney Therapeutics Advisory Group (TAG)
    The Norfolk and Waveney Therapeutics Advisory Group (TAG) REPORT April 2018 to March 2019 “Providing professional advice on the clinical efficacy, safety and cost effectiveness of new medicines and indications, and on prescribing responsibility across Norfolk and Waveney” Page 1 of 172 Contents Page Executive Summary • Introduction 3 • Role of the TAG 3 4 • Remit and process • Consultation process 4 • Supporting the Commissioning process 4 • Communicating TAG recommendations and CCG Commissioning Decisions 5 • The Norfolk & Waveney Prescriber newsletter 5 • TAG Recommendations 2018-19 – Headlines 6 • Membership of the TAG 6 • Attendance of TAG meetings 7 • Costs of running the TAG 8 General Conclusion 9 1. TAG Recommendations 2018-19 - Details A. New Drugs & Indications 10 B. NICE Guidance 58 C. Interface issues & Miscellaneous Guidance (including work from the 100 Prescribing Reference Group D. East of England Priorities Advisory Committee (PAC) 116 E. NHS England Specialised Commissioning / Early Access to Medicines Scheme 134 F. Regional Medicines Optimisation Committees (RMOCs) 137 G. MHRA Drug Safety Update Bulletins 144 2. Horizon Scanning for 2019/2020 146 3. Future Work Programme for the TAG A. PRIMARY CARE IMPACT • New drugs and treatments 147 • Shared Care prescribing Agreements 149 B. SECONDARY CARE IMPACT • New drugs / Indications in the pipeline that may arise in Secondary Care 150 • NICE Drugs – new Technology Appraisals due during 2019-20 152 • Non-NICE drugs 154 • The National Cancer Drugs Fund 155 APPENDIX 1. Terms of Reference for the TAG 137 APPENDIX 2. TAG Decision-Making Framework: 160 • TAG “Traffic Light” Classifications 160 • Grids used to support decision-making regarding new treatments 162 APPENDIX 3.
    [Show full text]
  • Trk Receptor Tropomyosin Related Kinase Receptor
    Trk Receptor Tropomyosin related kinase receptor Trk receptors are a family of three receptor tyrosine kinases (TrkA, TrkB, and TrkC), each of which can be activated by one or more of four neurotrophins-nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), and neurotrophins 3 and 4 (NT3 and NT4). TrkA, TrkB, and TrkC are transmembrane proteins that comprise the TRK receptor family. These receptor tyrosine kinases are expressed in human neuronal tissue, and play an essential role in both the physiology of development and function of the nervous system through activation by neurotrophins (NTs). The latter are specific ligands known as NGF for TrkA, BDGF, and NT-4/5 for TrkB and NT3 for TrkC, respectively. The binding of the ligand to the receptor triggers the oligomerisation of the receptors and phosphorylation of specific tyrosine residues in the intracytoplasmic kinase domain. This event results into the activation of signal transduction pathways leading to proliferation, differentiation and survival in normal and neoplastic neuronal cells. www.MedChemExpress.com 1 Trk Receptor Inhibitors, Agonists, Activators & Antagonists 7,8-Dihydroxyflavone Altiratinib Cat. No.: HY-W013372 (DCC-2701) Cat. No.: HY-B0791 7,8-Dihydroxyflavone is a potent and selective Altiratinib (DCC-2701) is a multi-targeted kinase TrkB agonist that mimics the physiological inhibitor with IC50s of 2.7, 8, 9.2, 9.3, 0.85, actions of Brain-derived neurotrophic factor 4.6, 0.83 nM for MET, TIE2, VEGFR2, FLT3, (BDNF). Displays therapeutic efficacy toward Trk1, Trk2, and Trk3 respectively. various neurological diseases. Purity: 99.90% Purity: 98.06% Clinical Data: No Development Reported Clinical Data: Phase 1 Size: 10 mM × 1 mL, 50 mg Size: 10 mM × 1 mL, 5 mg, 10 mg, 50 mg, 100 mg Amitriptyline hydrochloride ANA-12 Cat.
    [Show full text]
  • GROWTH PHARMA BRENT SAUNDERS Chief Executive Officer and President Customer Intimacy Is Critical PATIENTS
    GROWTH PHARMA BRENT SAUNDERS Chief Executive Officer and President Customer Intimacy is Critical PATIENTS Therapeutic Area Private Leader Companies Venture Capital Development Powerhouse Private Equity Commercial Machine CUSTOMER IDEAS Regional Business Players Development Start-Ups Customer Intimacy & Therapeutic Area Leadership Drive Commercial Success 2015 revenue1 Sales ($B) Ranking Top Brands Eye Care $3.0 2 global position in Alzheimer’s CNS $2.7 1 #3 global position Dermatology & global position Aesthetics $2.1 1 global position GI $1.2 3 #2 in anti-inflammatories in US Women’s Health $1.0 1 Plan to double presence by 2020 Urology $0.4 6 global position US leadership position Anti-infective $0.2 1 2 new breakthrough product launches SOURCE: Evaluate 1 Excludes generics; Botox sales allocated by TA/Indication into Dermatology & Aesthetics, CNS, and Urology A New Pharmaceutical Innovation Ecosystem Fueled by Significant Investments 6.5 3,500 6.0 5.4 3,000 4.9 Sustainability: 2,500 4.3 • Continued 3.8 2,000 VC funding 3.3 • Scientific 2.7 1,500 creativity Venture capital invested, $B Venture 2.2 1,000 Number of biotech startups • Professional 1.6 management 1.1 500 0.5 0 1995 2000 2005 2010 2014 SOURCE: Thomson Reuters, PitchBook database Pharma Innovation Ecosystem 1998 Source of NMEs by originator type REGIONAL BIOTECH & PHARMA 62% START-UPS Global Pharma 14% Biotech & Start-up Companies GLOBAL 24% PHARMA Regional Pharma Non-profit Academia ACADEMIA Specialty SPECIALTY Revenues of all NME-grade compounds launched in a given year cumulated for 7-8 years. Includes all innovative compounds classified as NME or BLA, excluding generics, biosimilars and NDA products (new derivatives, new formulations etc.) SOURCE: Evaluate 2014 New Pharma Innovation Ecosystem 2013 Source of NMEs by originator type 22% Global Pharma BIOTECH & 50% START-UPS Biotech & Start-up Companies REGIONAL PHARMA % GLOBAL 28 PHARMA Regional Pharma SPECIALTY Non-profit Academia Specialty ACADEMIA Evaluate Jul 20 Revenues of all NME-grade compounds launched in a given year cumulated for 7-8 years.
    [Show full text]
  • TFOS DEWS II Management and Therapy Report
    The Ocular Surface xxx (2017) 580e634 Contents lists available at ScienceDirect The Ocular Surface journal homepage: www.theocularsurface.com TFOS DEWS II Management and Therapy Report * Lyndon Jones, FCOptom PhD a, , Laura E. Downie, BOptom PhD b, Donald Korb, OD c, Jose M. Benitez-del-Castillo, MD PhD d, Reza Dana, MD e, Sophie X. Deng, MD PhD f, Pham N. Dong, MD g, Gerd Geerling, MD FEBO h, Richard Yudi Hida, MD i, Yang Liu, MD j, Kyoung Yul Seo, MD PhD k, Joseph Tauber, MD l, Tais H. Wakamatsu, MD PhD m, Jianjiang Xu, MD PhD n, James S. Wolffsohn, FCOptom PhD o, Jennifer P. Craig, MCOptom PhD p a Centre for Contact Lens Research, School of Optometry and Vision Science, University of Waterloo, Waterloo, Canada b Department of Optometry and Vision Sciences, University of Melbourne, Parkville, Victoria, Australia c Korb & Associates, Boston, MA, USA d Department of Ophthalmology, University of Complutense, Madrid, Spain e Department of Ophthalmology, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA, USA f Stein Eye Institute, UCLA, Los Angeles, CA, USA g Department of Corneal and External Disease, Vietnam National Institute of Ophthalmology, Hanoi, Viet Nam h Department of Ophthalmology, University Hospital Duesseldorf, Germany i Department of Ophthalmology, Santa Casa de Sao Paulo, University of Sao Paulo, Sao Paulo, Brazil j Schepens Eye Research Institute, Massachusetts Eye & Ear, Boston, MA, USA k Department of Ophthalmology, Yonsei University Medical College, Seoul, South Korea l Tauber Eye Center, Kansas City,
    [Show full text]
  • Lääkeaineiden Yleisnimet (INN-Nimet) 31.12.2019
    Lääkealan turvallisuus- ja kehittämiskeskus Säkerhets- och utvecklingscentret för läkemedelsområdet Finnish Medicines Agency Lääkeaineiden yleisnimet (INN-nimet) 31.12.
    [Show full text]
  • Translational Preclinical Pharmacologic Disease Models for Ophthalmic Drug Development
    Pharm Res (2019) 36: 58 https://doi.org/10.1007/s11095-019-2588-5 EXPERT REVIEW Translational Preclinical Pharmacologic Disease Models for Ophthalmic Drug Development Mihir Shah1 & Sara Cabrera-Ghayouri 1 & Lori-Ann Christie 1 & Katherine S. Held 1 & Veena Viswanath1 Received: 30 August 2018 /Accepted: 8 February 2019 /Published online: 25 February 2019 # The Author(s) 2019 ABSTRACT Preclinical models of human diseases are criti- ABBREVIATIONS cal to our understanding of disease etiology, pathology, and AAA Alpha-aminoadipic acid progression and enable the development of effective treat- AMD Age-related macular degeneration ments. An ideal model of human disease should capture ana- Ang1 Angiopoietin-1 tomical features and pathophysiological mechanisms, mimic Ang2 Angiopoietin-2 the progression pattern, and should be amenable to evaluating AqH Aqueous humor translational endpoints and treatment approaches. Preclinical BCVA Best corrected visual acuity animal models have been developed for a variety of human C5 Complement factor 5 ophthalmological diseases to mirror disease mechanisms, CFD Complement factor D location of the affected region in the eye and severity. CNV Choroidal neovascularization These models offer clues to aid in our fundamental CSME Clinically-significant macular edema understanding of disease pathogenesis and enable pro- DED Dry eye disease gression of new therapies to clinical development by DME Diabetic macular edema providing an opportunity to gain proof of concept DR Diabetic retinopathy (POC). Here, we review preclinical animal models asso- DRSS Diabetic Retinopathy Severity Scale ciated with development of new therapies for diseases of ECM Extracellular matrix the ocular surface, glaucoma, presbyopia, and retinal ERG Electroretinography diseases, including diabetic retinopathy and age-related GA Geographic Atrophy macular degeneration (AMD).
    [Show full text]