BREAKTHROUGH NANOTECH ENHANCES FRONT & BACK OF EYE DELIVERY
ZERO-ORDER SUSTAINED DELIVERY TO RETINA VIA NANOPOROUS FILM
OPHTHALMIC PRODUCT DEVELOPMENT: REDUCE RISK & FAILURE, DRIVE TIMELINESP16 P20 P32
OPHTHALMIC DRUG DELIVERY
The views and opinions expressed in this issue are those of the
authors. Due care has been used in producing this publication, but
the publisher makes no claim that it is free of error. Nor does the
publisher accept liability for the consequences of any decision or
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ONdrugDelivery Issue No 48, April 10th 2014
Ophthalmic Drug Delivery
This edition is one in the ONdrugDelivery series of publications from Frederick Furness Publishing. Each issue focuses on a specific topic within the field of drug delivery, and is supported by industry leaders in that field.
EDITORIAL CALENDAR 2014/15
Apr: Transdermal Patches, Microneedles & Needle-Free Injectors
Apr/May: Pulmonary & Nasal Drug Delivery May: Injectable Drug Delivery: Devices Focus June: Injectable Drug Delivery:
Pharmaceutics Focus July: Novel Oral Delivery Systems Sep: Drug Formulation & Delivery Solutions
& Services Oct: Prefilled Syringes Nov: Pulmonary & Nasal Drug Delivery Dec: Delivering Biotherapeutics Jan: Ophthalmic Drug Delivery Feb: Prefilled Syringes
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ONdrugDelivery Magazine is published by Frederick Furness Publishing Ltd. Registered Office: The Candlemakers, West Street, Lewes, East Sussex, BN7 2NZ, United Kingdom. Registered in England: No 8348388.VAT Registration No: GB 153 0432 49.ISSN 2049-145X printISSN 2049-1468 pdf
Copyright 2014 Frederick Furness Publishing LtdAll rights reserved
www.ondrugdelivery.com Copyright 2014 Frederick Furness Publishing Ltd2
04 - 07Ocular Drug Delivery: Review of Present Technologies & Steps ForwardDr Shikha P Barman, Chief Executive Officer, Chief Technology OfficerIntegral BioSystems, LLC
08 - 09 Company Profile: GrayBug, LLC
10 - 13
Improving Outcomes in Ophthalmology via Sustained Drug DeliveryDr Tomas Navratil, Vice-President, Development; Dr Benjamin Maynor, Vice-President, Research; and Dr Benjamin Yerxa, Chief Scientific OfficerEnvisia Therapeutics, Inc
16 - 18Breakthrough Nanotechnology Enhances Delivery to the Front and Back of the EyeDr Hongming Chen, Executive Vice-President of Research and Dr Robert Langer, Co-Founder and Board MemberKala Pharmaceuticals, Inc
20 - 21
Zero-Order Sustained Drug Delivery to the Retina from a Nanoporous Film DeviceDr Daniel A Bernards, Specialist, Department of Bioengineering & Therapeutic Sciences, UCSF, Dr Robert B Bhisitkul, Professor, Department of Ophthalmology, UCSF and Dr Tejal Desai, Professor and Vice-Chair, Department of Bioengineering & Therapeutic Sciences, UCSFZordera, Inc
23Company Profile: Encompass Ophthalmic DrugDevelopment Services
24 - 27Micro Ophthalmic Ocular ImplantsMs Donna Bibber, Chief Executive OfficerMicro Engineering Solutions, LLC
28 - 30Current and Future Ophthalmic Formulation and Process Development TrendsMr Brian McMillan, Vice-President Product DevelopmentCoreRx, Inc
32 - 35Ophthalmic Product Development: Reduce Risks, Mitigate Failure & Drive Timelines in a Competitive MarketMr Badre Hammond, Global Head of Business DevelopmentNext Breath, LLC
t *OOPWBUJWFEFWFMPQNFOUQSPDFTTDPNCJOJOH TUBUFPGUIFBSUJOWJUSPJOWJWPTDSFFOJOHTUVEJFT UPFDJFOUMZBOEFFDUJWFMZTQFFEPQIUIBMNJDESVH FWBMVBUJPOEFWFMPQNFOU
Contact: Rick Coulon Business Development Encompass Pharmaceutical Services, Inc
4 www.ondrugdelivery.com Copyright 2014 Frederick Furness Publishing Ltd
OPHTHALMIC DRUG PRODUCTS MARKET: CLINICAL AND BUSINESS NEED-DRIVEN
Market research estimates performed in the last six months have shown that the market size for ophthalmic medications is expected to reach more than 16 billion, by the year 2018.1 The ophthalmology drugs market classification is based on the type of drugs: treatment-based drugs, over-the-coun-ter (OTC) drugs and ocular anaesthetics.
In the last decade, clinical need has driven the ophthalmic drug development indus-try to make extraordinary strides forward both in drug design and in ocular delivery. Following the high profile scientific break-throughs of nucleic acid-based cell-targeted therapies (RNAi, aptamers), highly specific receptor-targeted small-molecule therapies, efficient cell-permeating small molecules and pro-drugs, retro-metabolic small molecules and drugs with better safety profiles, have been the introduction of intelligent drug delivery systems that claim to deliver to the targeted tissue for the required duration.
Combined with these clinical need-driv-en innovations are a plethora of tech-nologies that are business-driven, aimed at product extensions for life-cycle manage-ment of existing products. Each of these extensions offers improvements and benefits over current technologies, such as offering preservative-free options, or non-settling formulations, amongst others. From a regu-latory perspective, in the US, the number of 505(b)(2) applications claiming differenti-
ated technologies has risen dramatically, with fewer NDA (505(b)(1) applications for new chemical entities (NCEs) than there were in previous years.
The repurposing of previously approved molecules for other indications into products reformulated and optimised for ophthalmic delivery has the advantage of leveraging long-term relevant safety data in humans, offering a regulatory advantage with the US FDA approval process. If differentiated, IP protection is sought after, to gain maxi-mum product lifecycle extension for these products. In lock-step with these products is the generic ophthalmic products industry, offering high quality, pharmaceutically com-pliant products at an affordable cost. Thus, the ophthalmic products industry continues to seek a fine balance between innovation to meet both business and clinical needs and a relatively short regulatory timeline.
ANTERIOR SEGMENT & CHALLENGES TO DELIVERY
Common disorders of the anterior seg-ment of the eye include glaucoma, corneal keratitis, blepharitis, allergic conjunctivitis, cataracts, dry eye, and bacterial and fungal infections. Less common disorders are cor-neal dystrophies such as Fuchs endothelial dystrophy, and rarer infections (bacterial, viral and fungal) including herpes zoster and ocular herpes simplex. These infections can reduce visual clarity, produce corneal discharges and erode the cornea, sometimes leading to corneal scarring. Inflammatory
Here, Shikha Barman, PhD, Chief Executive Officer & Chief Technology Officer, Integral BioSystems, provides an
overview of the current state of play in the ocular drug delivery market, sets ocular drug delivery systems, both for the
anterior segment and the back of the eye, in the context of the wider ophthalmic therapeutics market, and highlights
how important it is for both ophthalmic drug discovery and ophthalmic drug delivery developments to progress
together in parallel.
OCULAR DRUG DELIVERY: REVIEW OF PRESENT TECHNOLOGIES & STEPS FORWARD
Dr Shikha P. BarmanChief Executive OfficerChief Technology Officer
T: +1 781-258-4039E: firstname.lastname@example.org
Integral BioSystems, LLC19A Crosby Drive, Suite 200Bedford, MA 01730United States
5Copyright 2014 Frederick Furness Publishing Ltd www.ondrugdelivery.com
disorders of the cornea include episcleritis, uveitis and keratitis.
Ophthalmic medications to treat the anterior segment of the eye are administered to the ocular surface, which includes the cornea, sclera and the highly intricate protein-rich mucosal-ocular membrane. Disorders of the biological-chemical-immunological balance of the ocular membrane can lead to the still-poorly understood dry-eye syndrome, which can then trigger a cascade of pro-inflammatory factors, which in turn can lead to other disorders.2 In highly populated urban areas, a high pro-pensity of contracting ocular surface diseases such as infections, allergies, symptoms of dry eye and corneal keratitis, has been reported. These diseases have been managed either by treatment of the symptoms (treatment-based drugs), or by addressing the root cause.
In the case of dry eye, treatment strate-gies have included use of drug-free artificial tear solutions to assua