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INNOVATIVE THERAPY FOR DRY EYE
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FRESHKOTE (APL-105)
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FRESHKOTE is the result of research to develop the Optimal Artificial Tear formulation; utilizing a collaboration of independent scientists under the direction of Dr. Frank Holly of The Dry Eye Institute.
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This highly-effective, patent pending product incorporates components for all 3 layers of the normal human tear film.
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- Clinical Study in Miami showed a dramatic increase in tear break up time after only one week of use. Investigator (Dr. Bill Trattler) reported that FRESHKOTE appeared to have a long-lasting positive affect on the ocular surface rather than just temporary relief of symptoms.
- Clinical Trial in Melbourne, Australia by Dr. Grant Mason demonstrated significant improvement in corneal staining and TBUT; with 33% of dry eye patients experiencing total regeneration of the ocular surface epithelial cells. Additional evaluation at largest eye clinic in Japan by Dr. Tsubota reported "The drops seem to be very wonderful".
- Sjogren's and other severe dry eye patients were the subjects of a West Texas clinical trial by Dr. Dave Lamberts; with 100% showing significant improvement in corneal staining, foreign body sensation, mucus discharge, burning & redness .. as compared to the control product (Tears Naturale - Alcon).
- Developed as APL-105 and trademarked as FRESHKOTE in the USA and EU, it may be marketed under other brand names globally.
- The USA patent was published in July 2004, with patents filed for all of Europe, Turkey, Brazil, Japan, Korea, and other countries.
- As presented at the Tear Film (TFOS) Conference in November 2004; an unusual and unique "cyber" study was conducted in over 200 patients with post-LASIK dry eye, with a subjective efficacy rating of 90% as compared to all other artificial tears not developed by Dr. Holly.
- In compliance with the FDA Ophthalmic Monograph; cleared by the British MHRA for marketing in the UK; CE Mark certification in November 2006 for all Countries of the European Union.
- FOCUS Laboratories launches FreshKote in the USA, in May of 2006.
- Altacor Ltd launches early 2008 in UK/Ireland under the brand: Clinitas Ultra 3.
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