Drug Product Development for the Back of the Eye
This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs. Specific topics covered in this book include:Solution, suspe
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Uday B. Kompella • Henry F. Edelhauser Editors
Drug Product Development for the Back of the Eye
Editors Uday B. Kompella Pharmaceutical Sciences & Ophthalmology Nanomedicine and Drug Delivery Laboratory University of Colorado Aurora, CO, USA [email protected]
Henry F. Edelhauser Department of Ophthalmology Emory University Eye Center Emory University Atlanta, GA, USA [email protected]
ISSN 2210-7371 e-ISSN 2210-738X ISBN 978-1-4419-9919-1 e-ISBN 978-1-4419-9920-7 DOI 10.1007/978-1-4419-9920-7 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2011931861 © American Association of Pharmaceutical Scientists, 2011 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Preface
Age-related macular degeneration and macular edema are major vision-threatening disorders of the back of the eye. The first therapeutic agents for treating these diseases, Macugen™ (Pfizer, a nucleic acid-based drug), Lucentis™ (Genentech; a protein drug), and Ozurdex™ (Allergan; a small molecule drug in a biodegradable, injectable implant) were approved by the US FDA in 2004, 2006, and 2009, respectively. Lucentis is already a billion-dollar product. With the success of Lucentis, there is an escalated activity for drug development for the back of the eye. Also, as evident earlier, a variety of therapeutic agents including nucleic acids, protein drugs, and small molecules are making inroads into the emerging back of the eye drug product market. Further, some unique delivery systems including surgically placed and injectable non-degradable implants have pioneered zero-order release of small molecule drugs for treating back of the eye diseases. Vitrasert™ and Retisert™, surgically placed intravitreal implants, were approved in 1996 and 2005, respectively, for treating cytomegalovirus retinitis and chronic non-inf
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