Methods and compositions for treating eye disorders

• US 7,220,422 B2
• Filed: 05/20/2003
• Issued: 05/22/2007
• Est. Priority Date: 05/20/2003
• Status: Expired due to Fees

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: First, Eric R.
• Primary Examiner(s): Navarro; Mark
• Assistant Examiner(s): PORTNER, VIRGINIA ALLEN
• Application Number:
  US10/442,590
• Publication Number:
  US 20040234532A1
• Time in Patent Office: 1,463 Days
• Field of Search: 424/423, 424/422, 424/184.1, 424/486, 424/236.1, 424/247.1, 424/259, 424/260, 424/274.1, 604/521, 604/294, 514/964, 514/220, 435/5
• US Class Current: 424/247.1
• CPC Class Codes: A61K 38/4893 Botulinum neurotoxin (3.4.24.69)
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 37/02 Immunomodulators

Abstract

The present invention provides methods of treating an eye disorder. The methods comprise a step of locally administering a Clostridial toxin to the eye of a patient to treat the disorder. The eye disorder may be associated with an inflammation of the eye, including for example, bacterial conjunctivitis, fungal conjunctivitis, viral conjunctivitis, uveitis, keratic precipitates, macular edema, and inflammation response after intra-ocular lens implantation. The Clostridial toxin may be produced by a Clostridial beratti, a Clostridia butyricum, a Clostridial tetani bacterium and/or a Clostridial botulinum.

Claims

1. An ophthalmic composition comprising:

an ophthalmically acceptable carrier;

a Clostridial toxin in an amount effective to treat an eye disorder when the composition is administered to an eye;

a polyanionic component in an amount effective to provide lubrication to an eye when the composition is administered to an eye, wherein said composition is a solution and wherein the polyanionic component comprises from about 0.05% (w/v) to about 5% (w/v) of said composition.

2. The ophthalmic composition of claim 1, wherein the Clostridial toxin is a botulinum toxin type selected from the group consisting of botulinum toxin type A, B, C₁, D, E, F, G and mixtures thereof.

3. The ophthalmic composition of claim 1, wherein the Clostridial toxin is botulinum toxin type A.

4. An ophthalmic composition comprising:

an ophthalmically acceptable carrier;

a Clostridial toxin in an amount effective to treat an eye disorder when the composition is administered to an eye;

a polyanionic component in an amount effective to provide lubrication to an eye when the composition is administered to an eye, wherein said composition is a solution and wherein the polyanionic component comprises from about 0.3% (w/v) to about 2% (w/v) of said composition.

5. The ophthalmic composition of claim 4, wherein the Clostridial toxin is a botulinum toxin type selected from the group consisting of botulinum toxin type A, B, C₁, D, E, F, G and mixtures thereof.

6. The ophthalmic composition of claim 4, wherein the Clostridial toxin is botulinum toxin type A.

7. An ophthalmic composition comprising:

an ophthalmically acceptable carrier;

a Clostridial toxin in an amount effective to treat an eye disorder when the composition is administered to an eye;

a polyanionic component in an amount effective to provide lubrication to an eye when the composition is administered to an eye, wherein said composition is a solution; and

a vasoconstrictor, wherein the vasoconstrictor comprises from about 0.001% (w/v) to about 0.5% (w/v) of said composition.

8. The ophthalmic composition of claim 7, wherein the Clostridial toxin is a botulinum toxin type selected from the group consisting of botulinum toxin type A, B, C₁, D, E, F, G and mixtures thereof.

9. The ophthalmic composition of claim 7, wherein the Clostridial toxin is botulinum toxin type A.

10. The An ophthalmic composition comprising:

an ophthalmically acceptable carrier;

a Clostridial toxin in an amount effective to treat an eye disorder when the composition is administered to an eye;

a polyanionic component in an amount effective to provide lubrication to an eye when the composition is administered to an eye, wherein said composition is a solution; and

a vasoconstrictor, wherein the vasoconstrictor comprises from about 0.005% (w/v) to about 0.2% (w/v) of said composition.

11. The ophthalmic composition of claim 10, wherein the Clostridial toxin is a botulinum toxin type selected from the group consisting of botulinum toxin type A, B, C₁, D, E, F, G and mixtures thereof.

12. The ophthalmic composition of claim 10, wherein the Clostridial toxin is botulinum toxin type A.

13. An ophthalmic composition comprising:

an ophthalmically acceptable carrier;

a Clostridial toxin in an amount effective to treat an eye disorder when the composition is administered to an eye;

a polyanionic component in an amount effective to provide lubrication to an eye when the composition is administered to an eye, wherein said composition is a solution; and

a vasoconstrictor, wherein the vasoconstrictor comprises from about 0.001% (w/v) to about 0.5% of said composition, and wherein the vasoconstrictor is selected from the group consisting of tetrahydrozoline, ephedrine, naphazoline, and phenylephrine and mixtures thereof.

14. The ophthalmic composition of claim 13, wherein the Clostridial toxin is a botulinum toxin type selected from the group consisting of botulinum toxin type A, B, C₁, D, E, F, G and mixtures thereof.

15. The ophthalmic composition of claim 13, wherein the Clostridial toxin is botulinum toxin type A.