Out-licensing

FRESHKOTE (APL-105): New 3-Layered Artificial Tear Available for Licensing

Introduction/Background

Dry eye syndrome is the most prevalent ocular problem; due to a deficiency in the quantity and/or quality of the human tear film or due to lifestyle. The normal human tear film is comprised of 3 layers (mucin – aqueous – lipid). Recent research has shown that evaporation of tears is a problem in 70% of all dry eye patients (NIH/NEI). The lipid layer is by far the thinnest of the 3 but yet responsible for preventing premature evaporation of the tears. In addition to ageing, Lifestyle changes are responsible for greatly increased numbers of dry eye patients, since millions of people spend many hours per day in front of a computer, so the blink rate is reduced by 80%, leading to dry eye. The tears are replenished with each blink of the eyelids.

Aims/Hypothesis

Aqueous Pharma is solely dedicated to innovative therapy for dry eye; working closely with the esteemed Dr. Frank J. Holly of the Dry Eye Institute. Our goal was to develop the optimal artificial tear that would be highly effective in all levels of dry eye and preserved with an effective but yet benign chemical to allow for the less expensive multi-dose packaging. Aqueous also owns the original "core" artificial tears developed by Dr. Holly (NutraTear®, Dakrina® and Dwelle®) as well as the unique ophthalmic preservative (polixetonium) used in all 4 tears; and have 3 products in development. The most significant of the latter is APL-106, a breakthrough-type product to increase production of the tears.

Research

Dr. Holly and colleagues developed APL-105, which has the following properties: (1) Proprietary lipid component to address evaporation, (2) Synergistic blending of polymers for the mucus component; (3) An oncotic pressure of 65mm/Hg (average tear product is 2mm/Hg) to provide enhanced wettability and actual tissue healing for the corneal and conjunctival epithelial cells, (4). Preserved with a safe, effective ophthalmic solution preservative, which is non-irritating to the ocular surface even after continuous daily use for dry eye. 5 clinical studies were completed in 3 countries. Reports indicate a very significant improvement in TBUT (tear break up time), corneal staining, redness; as well as very positive subjective commentary.

Conclusion

FreshKote (APL-105) is a new 3-layered artificial tear with the highest oncotic pressure (65mm/Hg) to provide healing of the ocular surface. This innovative product is preserved with the only totally non-irritating ophthalmic preservative (polixetonium chloride); unlike the commonly used benzalkonium chloride. APL-105 is compliant with the FDA Ophthalmic Monograph and has been approved, via CE Mark, for all countries of the European Union.

Relevance/Opportunity

It is licensed for the USA/Canada to Focus Labs of Arkansas USA, and for the UK/Ireland to Altacor Ltd of Cambridge, England. Other territories are available. Please enquire below if you are interested in exclusively licensing FRESHKOTE (APL-105) and/or have interest in all of Aqueous Pharma's assets.

Registered

The technology is patent pending in the USA and several others countries and the patent has been approved by the European Patent Office.