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Peter F Kador, Jane Meza, Milton Wyman, Manley Paulos, Karen Blessing; KinostatTM can Eliminate the Need for Cataract Surgery in Newly Diagnosed Diabetic Dogs. Invest. Ophthalmol. Vis. Sci. 2016;57(12):No Pagination Specified. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
A majority of dogs develop blinding bilateral cataracts within 12 months after diagnosis of diabetes mellitus (DM). At present to only clinical treatment for these dogs is surgery. Here, we present the clinical results of a randomized masked placebo controlled trial (1/3 placebo) conducted at 11 centers across the United States of the topical aldose reductase inhibitor of KinostatTM evaluating the ability of this drug to prevent the development of blinding cataracts.
Newly diabetic dogs of all sizes, breeds, and sex with only equatorial vacuoles of less than 360o present and no other ocular disease were recruited with the endpoint of the study being the development of cortical cataracts by 9 months. Dogs were evaluated by board certified veterinary ophthalmologists at the time of enrollment and at 1, 2, 3, 6 and 9 months. The dog’s owners administered the topical formulations TID. All dogs not developing cortical cataracts during the 9-month clinical trial period were then transferred to an open label KinostatTM long-term study with ophthalmic evaluations required at 6-month intervals.
One hundred thirty four dogs completed the initial 9-month study and the results, confirm the initial proof of concept study (Vet. Ophthlamol. 13:363-8, 2010) that daily administration of KinostatTM to diabetic dogs significantly prevents cataract formation for up to 6-years. A required toxicology study found that daily application of KinostatTM at doses of up to 5x the recommended doses did not induce any direct local or systemic toxic effects in any of the tissues examined.
KinostatTM is the first drug to prevent the clinical development of diabetic cataracts and represents an alternate treatment paradigm that reduces the need for cataract surgery. Because KinostatTM meets an unmet medical need, the FDA has granted KinostatTM a fast-track Minimum Use in a Major Animal Species designation.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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