Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2001-03-23
2003-12-09
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S451000, C424S489000, C424S400000, C424S427000
Reexamination Certificate
active
06660297
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a nutritional or dietary supplement composition that strengthens and promotes retinal health through the prevention, stabilization, reversal and/or treatment of visual acuity loss in people with particular ocular diseases. More specifically, the present invention relates to an antioxidant and high-dosage zinc nutritional or dietary supplement composition that decreases visual acuity loss by reducing the risk of developing late stage or advanced age-related macular degeneration in persons with early age-related macular degeneration. The subject composition may likewise reduce the risk of vision loss associated with the development of cataracts.
BACKGROUND OF THE INVENTION
Macular degeneration associated with age and drusen is the leading cause of severe visual acuity loss in the United States and Western Europe in persons aged 55 years old or older. Age-related macular degeneration (AMD) is a collection of clinically recognizable ocular findings that can lead to blindness. The findings include drusen, retinal pigment epithelial (RPE) disturbance—including pigment clumping and/or dropout, RPE detachment, geographic atrophy, subretinal neovascularization and disciform scar. Not all these manifestations are needed for AMD to be considered present. The prevalence of persons with ophthalmoscopically or photographically identifiable drusen increases with age, and most definitions of AMD include drusen as a requisite. However, drusen alone do not seem to be directly associated with vision loss. It is rather, the association of drusen with the vision-threatening lesions of AMD, i.e., geographic atrophy, RPE detachment and subretinal neovascularization, that has led to their inclusion in the definition of AMD. Although recent studies have demonstrated the benefit of laser photocoagulation in those individuals with macular degeneration who develop acute, extrafoveal choroidal neovascularization, no treatment has been shown to be of benefit to the majority of people who have AMD. The cause of macular degeneration is unknown.
Recently, attention has been focused on the possible involvement of various minerals in retinal disease. Zinc has received particular notice in this regard due to the observation of high concentrations of zinc in ocular tissues, particularly the retina, pigment epithelium and choroid. Zinc is an important micronutrient that plays an essential role in human growth and function. Zinc is necessary for the activity of over a hundred enzymes, including carbonic anhydrase, superoxide dismutase and alkaline phosphatase. Zinc acts as a cofactor for numerous metalloenzymes, including retinol dehydrogenase and catalase. Zinc also is a cofactor in the synthesis of extracellular matrix molecules, is essential for cell membrane stability, is needed for normal immune function, is associated with melanin and is taken up in a facilitated manner by the retinal pigment epithelium. Despite the evidence supporting the notion that zinc must be essential to the metabolism of the retinochoroidal complex, relatively little is known of its role in the maintenance of normal eye function.
Toxicity from free radicals and oxidizers has also generated significant interest with regard to macular degeneration and the progression thereof. Circumstantial evidence indicates that protection against phototoxicity and oxidizers, such as would be provided by antioxidants, could slow the onset and progression of age-related macular degeneration as well as cataracts. If a treatment modality could slow down the progression of macular degeneration and/or cataracts, it would have a tremendous impact on the number of individuals who suffer from such problems due to the fact that such problems generally occur at significantly more advanced ages.
Accordingly, a need still exists in the art to provide methods and compositions for the treatment of macular degeneration and/or cataracts in the absence of surgery.
SUMMARY OF THE INVENTION
The present invention is a nutritional or dietary supplement composition for administration to humans or other animals that strengthens and promotes retinal health through the prevention, stabilization, reversal and/or treatment of visual acuity loss in people with particular ocular diseases. The present nutritional or dietary supplement composition may also be administered to prevent, stabilize, reverse and/or treat cataract development. The present nutritional or dietary supplement composition preferably comprises an effective amount of specific antioxidants and high-dosage zinc to decrease visual acuity loss. Visual acuity loss is decreased through the use of the present composition by reducing the risk of developing late stage or advanced age-related macular degeneration in persons with early age-related macular degeneration. The present composition may likewise reduce the risk of visual acuity loss associated with the development of cataracts.
The present invention likewise provides a method of treating a human or other animal by administering a nutritional or dietary supplement composition comprising an effective amount of specific antioxidants and high-dosage zinc to decrease visual acuity loss. The practice of this invention involves supplementing the diet of humans or animals by oral, intraperitoneal, intravenous, subcutaneous, transcutaneous or intramuscular routes of administration with the subject antioxidant and high-dosage zinc formulation.
The present invention likewise provides a method of manufacturing a nutritional or dietary supplement composition comprising an effective amount of specific antioxidants and high-dosage zinc to decrease visual acuity loss.
Accordingly, it is an object of the present invention to provide a nutritional or dietary supplement composition effective in the prevention, stabilization, reversal and/or treatment of macular degeneration and/or visual acuity loss.
Another object of the present invention is to provide a safe nutritional or dietary supplement composition for the prevention, stabilization, reversal and/or treatment of macular degeneration and/or visual acuity loss.
Another object of the present invention is to provide an effective method of preventing, stabilizing, reversing and/or treating macular degeneration and/or visual acuity loss.
Another object of the present invention is to provide a safe method of preventing, stabilizing, reversing and/or treating macular degeneration and/or visual acuity loss.
Another object of the present invention is to provide a method of manufacturing a safe nutritional or dietary supplement composition for the prevention, stabilization, reversal and/or treatment of macular degeneration and/or visual acuity loss.
Still another object of the present invention is to provide a method of manufacturing a nutritional or dietary supplement composition effective in the prevention, stabilization, reversal and/or treatment of macular degeneration and/ or visual acuity loss.
These and other objectives and advantages of the present invention, some of which are specifically described and others that are not, will become apparent from the detailed description and claims that follow.
REFERENCES:
patent: 5075116 (1991-12-01), LaHaye et al.
patent: 5607707 (1997-03-01), Ford et al.
patent: 5739156 (1998-04-01), Bissett
patent: 5770217 (1998-06-01), Kutilek, III et al.
patent: 5948443 (1999-09-01), Riley et al.
patent: 5976568 (1999-11-01), Riley
patent: 6020351 (2000-02-01), Pero
patent: 6103756 (2000-08-01), Gorsek
patent: 200 12 510 U 1 (2000-11-01), None
patent: 0 930 072 (1999-07-01), None
patent: 2 301 775 (1996-12-01), None
patent: WO 01 19383 (2001-03-01), None
patent: WO 01 91765 (2001-12-01), None
Newsome, D. A., Oral Zinc in Macular Degeneration, Arch. Ophthalmol., vol. 106, Feb. 1988, pp. 192-198.*
Age-Related Eye Disease Study Research Group, The Age-Related Eye Disease Study: A Clinical Trial of Zinc and Antioxidants—Age-Related Eye Disease Study Report No. 2, Journal of Nutrition, 2000.
R. E. Wyszynski, A Donor-Age-Dependent Change in the Activit
Bartels Stephen Paul
Baustian Cara Larraine
Bunce George Edwin
Ellenbogen Leon
Ferris, III Frederick L.
Bausch & Lomb Incorporated
Joynes Robert M.
Page Thurman K.
Polyn Denis A.
Vacca Rita D.
LandOfFree
Nutritional supplement to treat macular degeneration does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Nutritional supplement to treat macular degeneration, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Nutritional supplement to treat macular degeneration will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3107515