A New Opportunity for Dry Eye.
What if an established medicine could help transform the experience of dry eye?
During an early clinical investigation of topical atorvastatin, a patient's experience provided a striking illustration of the potential impact of the treatment. Read the story as featured in Insight News and INSPIRE (page 48)
Drug Repurposing - Patented IP - Human Pilot Data.
University of Sydney research into topical atorvastatin for dry eye and blepharitis is seeking A$1 million to progress the technology toward commercialisation in Australia and beyond.
Dry eye isn't trivial. For many people, it is life-changing.
A global problem.
Dry eye disease
- widespread and increasing.
- can cause recurrent blurred vision and ocular surface discomfort.
- can interfere with work and daily activities.
- frequently occurs alongside blepharitis.
A growing market.
- US$6B+ - US$12.3B projected globally.
- ~ 7.4% CAGR.*
*Market estimates vary by source and methodology.
The commercial opportunity.
A$1M - Current capital requirement. A defined initial market and commercialisation opportunity.
Global IP - International patent position.
Licensing potential - Potential partnership/licensing opportunities beyond Australia.
Business Case - A$12.3M potential annual revenue* under current model assumptions. The immediate objective is progress the technology toward commercialisation locally in Australia, establish a viable product and create a foundation for subsequent licensing, partnerships and international expansion.
*Illustrative modelling, not a revenue forecast or guarantee.
A pragmatic pathway to market.
The project is investigating regulatory pathways that may allow the topical formula to reach patients through a comparatively streamlined pathway, including potential non-prescription/OTC registration in Australia, subject to regulatory advice, product classification and the evidence requirements applicable to the final formulation and indication.
A large market does not always require a blockbuster strategy.
The global dry eye market is measured in billions of dollars and is projected to continue growing. The project's business case models a substantial Australian opportunity, even using relatively conservative patient assumptions.
The research: A second life in ophthalmology.
The technology is supported by a body of laboratory, population-based and early clinical research.
Timeline
- 2011-2013 - patent development / IP.
- Preclinical and laboratory research - HMG-CoA reductase identified in human eyelid tissue laboratory investigation of statin effects.
- Population research - association between oral statin use and dry-eye symptoms investigated.
- 2015 - pilot clinical study of topical atorvastatin in 10 patients with dry eye associated with blepharitis.
- Today - commercialisation opportunity.
Atorvastatin is one of the world's most widely used medicines for lowering cholesterol.
- Researchers - at the University of Sydney's Save Sight Institute have investigated its potential for topical ophthalmic use in dry eye and blepharitis.
- Repurposed - an established pharmaceutical ingredient rather than a newly discovered molecule.
- Topical - reformulated for application to the ocular surface.
- Differentiated - the research program investigates the relationship between tear-film cholesterol, Meibomian gland function, inflammation and blepharitis.
The topical statin technology is protected by patent rights originating from research undertaken through the University of Sydney/UNSW commercialisation pathway:
International IP Protection:
- Australia - Granted.
- Japan - Granted.
- Europe - Granted/Validated in designated jurisdictions
- UK - Granted.
- USA - Application under examination.
Led by experienced ophthalmology researchers.
Professor Stephanie Watson OAM
- University of Sydney - Save Sight Institute.
- Head, Corneal Research Group.
- Head, Corneal Unit.
- 200+ Publications.
- OAM for services to ophthalmology.
Dr Kenneth Ooi
Ophthalmologist and clinical researcher specialising in ocular inflammation and dry eye, and co-inventor associated with the topical statin technology.
The research team has also worked with and advised major ophthalmology and pharmaceutical organisations internationally.
Disclaimer
Important information: AusDryEye is a patient advocacy and information initiative. The website is intended to facilitate awareness and introductions regarding research and commercialisation opportunities and does not constitute medical advice, an offer of securities or a representation that regulatory approval or commercial success will be achieved. Investment and commercialisation enquiries should be directed to the relevant official and legal project representatives.
Research Status: Statements regarding efficacy, safety, regulatory pathways and commercial potential reflect the information provided by the research/commercialisation team and should not be interpreted as a guarantee of clinical or regulatory outcomes.
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