Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-11-30
2001-04-17
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S152000, C514S398000, C514S468000, C514S471000
Reexamination Certificate
active
06218368
ABSTRACT:
TABLE OF CONTENTS
1. BACKGROUND OF THE INVENTION
1.1 TECHNICAL FIELD
1.2 BACKGROUND OF ART
2. SUMMARY OF THE INVENTION
3. BRIEF DESCRIPTION OF THE DRAWINGS
4. DESCRIPTION OF PREFERRED EMBODIMENTS
5. CLAIMS
6. ABSTRACT OF THE DISCLOSURE
7. DRAWING
8. DECLARATION AND POWER OF ATTORNEY
9. DECLARATION OF SMALL ENTITY STATUS
1. BACKGROUND OF THE INVENTION
1.1 Technical Field
The present invention is directed to the treatment of age-related macular degeneration (ARMD) by the administration of certain antibiotics. In one embodiment, broad-spectrum bacteriostatic antibiotics, such as tetracycline-based antibiotics (TBA), are administered for up to fourteen (14) months, which leads to measurable improvements in some of the symptoms.
1.2 Background of Art
Age-related macular degeneration (ARMD) is the leading cause of blindness among persons over fifty in the United States and other countries (Bressler NM et al., Age-related macular degeneration.
Surv. Ophthalmol
. 1988; 32:375-413). Two forms of age-related macular degeneration are known: (1) neovascular, also known as exudative, age-related macular degeneration (E-ARMD) and (2) nonneovascular, also known as nonexudative, age-related macular degeneration (NE-ARMD). NE-ARMD is characterized by the presence of drusen, yellow-white lesions of the retinal pigment epithelium within the macula, and by other abnormalities of the retinal pigment epithelium, including retinal cell death.
Although the exact etiology of ARMD is not known, several risk factors seem to be important for the manifestation of this disease. For example, ARMD may be caused by chronic exposure of the retina to light. The presence or absence of certain nutrients in the diet, such as the antioxidant vitamins E and C, also may affect one's predisposition for ARMD. Other conditions, such as hypertension and smoking, are also considered to be important risk factors for the development of this disease.
Recent histopathologic studies show that leukocytes and chronic inflammation may play a role in the pathogenesis of atrophic NE-ARMD (Penfold PL et al., Senile macular degeneration: The involvement of giant cells in the atrophy of the retinal pigment epithelium.
Invest. Ophthalmol. Vis. Sci
. 1986; 27:364-371) and E-ARMD (Penfold PL et al., Age-related macular degeneration: Ultrastructural studies of the relationship of leucocytes to angiogenesis.
Graefe's Arch. Ophthalmol
. 1987; 2256:70-76).
Several therapeutic methods have been tried. For example, vitamins and dietary supplements have been used for the purpose of delaying the onset of disease. Thalidomide is being investigated to determine if it will slow down or arrest new vessel formation. Laser or radiation has been used to destroy new vessels. However, none of these methods has led to successful results and no definitive treatment for ARMD has been developed to date.
2. SUMMARY OF THE INVENTION
The present invention is directed to the treatment of both E-ARMD and NE-ARMD by the long-term administration of antibiotics in therapeutically effective dosages which are safe for such prolonged usages. In one embodiment, a broad-spectrum, bacteriostatic antibiotic, such as tetracycline (250-1000 mg per day) is orally administered for six (6) weeks to fourteen (14) months.
Tetracyclines are broad spectrum bacteriostatic antibiotics known to have “collagenase inhibition properties, anti-oxidant activity, inhibition of protein synthesis in rapidly dividing cells, perturbation of leukocyte functions, interference with lymphocyte proliferation and anti-inflammatory effects” (Tilley BC et al., Minocycline in rheumatoid arthritis. A forty-eight (48) week double blind placebo controlled trial. MIRA trial Group.
Annals of Internal Medicine
. 1995; 122(2):81-89). Forty-eight (48) week therapy with TBA has been shown to moderate the signs and symptoms of inflammatory diseases such as rheumatoid arthritis (Tilley BC et al., Minocycline in rheumatoid arthritis. A forty-eight (48) week double blind placebo controlled trial. MIRA trial Group.
Annals of Internal Medicine
. 1995; 122(2):81-89). Its limited toxicity has enabled it to be used chronically as therapy for diverse diseases including acne rosacea (Brown SI et al., Diagnosis and treatment of ocular rosacea.
Ophthalmology
. 1978; 85:779-786) which is commonly seen in the elderly. Animal studies reveal that intravenous tetracycline achieves high concentrations in the uvea and retina (Salamon SM, Tetracyclines in ophthalmology.
Surv. Ophthalmol
. 1985; 29:265-275).
In addition to tetracycline, other antibiotics may be used, including tetracycline derivatives, such as minocycline, doxycycline, and oxycycline, but most preferably minocycline (100-200 mg per day); rifamycin and its derivatives, such as rifabutin (150-300 mg per day) and rifampin (150-300 mg per day), but most preferably rifabutin; macrolides, such as azithromycin, erythromycin, and clarithromycin, but most preferably azithromycin (250-500 mg per day) and erythromycin (400-1200 mg per day as ethyl succinate); and metronidazole (375 mg per day). Furthermore, antibiotics can be administered orally or parenterally, including intravenously, intramuscularly, or subcutaneously, as the case may be for the particular antibiotic and the modes of administration of these clinically recognized antibiotics are already set in the literature.
The invention is based, in part, on the discovery that the administration of certain antibiotics, especially tetracycline-based antibiotics (TBA), to individuals with ARMD for unrelated non-ocular diseases for a period of up to fourteen (14) months, led to measurable improvements in visual acuity and in peripheral fields when there was such loss.
REFERENCES:
patent: 6015803 (2000-01-01), Wirostko
Pennie & Edmonds LLP
Peselev Elli
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