July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Kinostat® Clinically Prevents Diabetic Cataracts Independent of Hyperglycemia Levels
Author Affiliations & Notes
  • Peter F Kador
    Therapeutic Vision, Inc, Omaha, Nebraska, United States
    Univ of Nebraska Medical Ctr, Omaha, Nebraska, United States
  • Lynette Smith
    Univ of Nebraska Medical Ctr, Omaha, Nebraska, United States
  • Milton Wyman
    Therapeutic Vision, Inc, Omaha, Nebraska, United States
  • Manley Paulos
    Therapeutic Vision, Inc, Omaha, Nebraska, United States
  • Karen Blessing
    Therapeutic Vision, Inc, Omaha, Nebraska, United States
    Univ of Nebraska Medical Ctr, Omaha, Nebraska, United States
  • Footnotes
    Commercial Relationships   Peter Kador, Therapeutic Vision, Inc (I), Therapeutic Vision, Inc (P), Therapeutic Vision, Inc (E); Lynette Smith, None; Milton Wyman, ther (P), Therapeutic Vision, Inc (E), Therapeutic Vision, Inc (I); Manley Paulos, Therapeutic Vision, Inc (E), Therapeutic Vision, Inc (I); Karen Blessing, Therapeutic Vision, Inc (E), Therapeutic Vision, Inc (I)
  • Footnotes
    Support  EY018013-02A; EY018013-2B; Nebraska SBIR Fund; FDA MUMS
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 1384. doi:
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    • Get Citation

      Peter F Kador, Lynette Smith, Milton Wyman, Manley Paulos, Karen Blessing; Kinostat® Clinically Prevents Diabetic Cataracts Independent of Hyperglycemia Levels. Invest. Ophthalmol. Vis. Sci. 2019;60(9):1384.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Results from a randomized, multicenter, masked, placebo-controlled clinical trial under FDA IAND 11-785 demonstrate that the topical aldose reductase inhibitor Kinostat® prevents diabetic cataracts and dry eye development in diabetic dogs. Since diabetic cataracts are linked to glycemic control, we demonstrate that differences in glycemic control did not adversely affect the clinical results.

Methods : Newly diabetic dogs with no lens changes or equatorial vacuoles < 360o present were recruited with the development of cortical cataracts by 9 months as the endpoint. Veterinary ophthalmologists examined all dogs at 0, 1, 2, 3, 6 and 9 months and the dog owners administered the masked medications TID. Hyperglycemia was measured as FDA required fructosamine levels by IDEXX Laboratories at each visit. A generalized linear mixed effect model was generated from the fructosamine data to investigate the development of osmotic cataracts over time with a binomial distribution and logit link. In this model, the treatment group, fructosamine levels (as continuous), and time period were considered as fixed effects.

Results : Fructosamine levels were not significantly different between the Kinostat® and placebo groups; however, Kinostat®-treated dogs were 85% less likely to develop cortical cataracts by 9 months. Overall average fructosamines (0, 1, 2, 3, 6 and 9 months) in the placebo group with no cataracts was 399 ± 17 compared to 419 ± 11 for the Kinostat® group. Fructosamines were 457 ± 22 for placebos with cataracts compared to 502 ± 23 for the Kinostat® group. Dogs developing osmotic cataracts had significantly higher (p=0.0002) fructosamine levels (479 ± 16) compared to those not developing cataracts (408 ± 10). Every 10 µmol/L increase in fructosamine in the placebo group increased cataract development by 7% at 9 months (p=0.013).

Conclusions : The fructosamine data supports the premise that hyperglycemia is linked to diabetic cataracts. Kinostat® prevents diabetic cataracts by preventing the metabolism of excess glucose to sorbitol independent of hyperglycemia levels present.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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