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Eye on Innovation
Healthegy, the organizer of OIS, is creating a broader platform for Ophthalmology's leaders. Today, we welcome Michael O'Rourke, President of Scotia Vision Consultants and Dr Ilva Rupenthal, Drug Delivery Research Scientist, at the University of Auckland, New Zealand.

If you would like to contribute a piece to this newsletter please contact Content Director Tom Salemi at Tom@healthegy.com.
Meeting the Challenges of Sustained Drug Delivery
 
DESPITE the seemingly ubiquitous ophthalmic media coverage of “sustained release ocular drug delivery”, only four posterior segment products have overcome the challenges of development and achieved broad regulatory approval with a degree of commercial success since 1995.

So why are there only four (Vitrasert, Retisert, Ozurdex and Iluvien) to date and what lies ahead?

Several factors contribute to the challenge of developing new sustained release drug delivery systems including;
  • The primary need to match the drug with the delivery technology. This requires demonstrating sustained delivery pharmacokinetics and using the appropriate animal model for testing the drug's safety and efficacy.
     
  • The right clinical trial design and understanding that platform compatibility differs with compound solubility and molecule size also is essential.
     
  • The identification and ultimate granting of intellectual property rights is crucial.
     
  • In addition, sourcing the appropriate funding or partnerships to move the technology through its IND and clinical stages is a critical success factor. 

Despite these barriers, multiple technologies and approaches, both posterior and anterior, are in either pre- or clinical development. 

The current gold-standard to treat posterior segment conditions, such as wet age-related macular degeneration (w-AMD) and diabetic related retinal disease, remains intravitreal injection (IVT), with approx. 16.4 million IVT’s administered globally in 2014.

This multi-billion dollar IVT injection market has demonstrated that a proven sustained-release implantable technology itself is not a prerequisite for commercial success, but that a sustained clinical and targeted effect of the drug may be critical. However, the onerous need for monthly or bi-monthly injections may not be ideal from a patient adherence or comfort perspective and, potentially, for safety reasons.

Therefore, a major opportunity exists to develop new delivery technologies to enhance the treatment of the major blinding diseases for patients and to capture the increasingly lucrative commercial market opportunities they offer.

The future for sustained-release ocular drug delivery will include reducing the treatment burden of IVT’s through innovations in delivery technologies for both small and large molecules and in all cases combining effective therapeutics with the appropriate drug delivery system. Established “Big Pharma” will need to consider “Product Life Cycle” extension strategies to include new drug delivery technologies, although it is most likely that the “innovation” for the technology will come from the “Start Up” environment.

All technologies approved today use existing generic drugs so the choice of drug comes first, then is matched with a delivery technology although the process is not an exact science. It may be ideal to have a broad drug delivery platform technology, customized to new drugs, or a class of drugs, remembering each drug compound will require a different release profile and formulation.

Due to the large numbers of products in the pipeline, the selected product development strategy must offer a “disruptive technology,” that is, disrupting the market compared to what already exists or is in the development pipeline. It should offer true innovation to both patients and doctors, meet a significant market need and offer both clinical feasibility and potential reimbursement.

Novel technologies required to deliver agents specifically and effectively to the eye are rapidly evolving. These will have the potential to radically alter the way many ocular conditions are treated, especially retinal blinding diseases and glaucoma. The next decade promises great strides in therapy achieved through sustained release drug delivery for many currently poorly-treated or untreatable ocular diseases.

Michael O’Rourke, President and Founder of Scotia Vision Consultants, a specialized ophthalmic consulting company with expertise in pharmaceutical, drug delivery and medical device strategies. (scotiavc@gmail.com)

Dr Ilva Rupenthal, Buchanan Ocular Therapeutics Unit, Department of Ophthalmology, University of Auckland, New Zealand. (i.rupenthal@auckland.ac.nz)

 
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Your Story @ OIS

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Octane

2015 Orange County Ophthalmology Technology Summit

Join Tom Salemi and Craig Simak on June 16th in Costa Mesa for the Orange County Ophthalmology Technology Summit.

The purpose of the Orange County Ophthalmology Technology Summit meeting is to create a local forum where leading ophthalmology technologists, researchers, clinicians, and entrepreneurs can come together to discuss current industry trends, unmet clinical needs, and new business opportunities all to fuel the ophthalmology ecosystem in Orange County, California.

Learn More!

 
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