Insert for the treatment of dry eye

• US 20040176749A1
• Filed: 01/07/2004
• Published: 09/09/2004
• Est. Priority Date: 07/12/2001
• Status: Abandoned Application

• Current Assignee: Achim Goepferich, Chris P. Lohmann
• Original Assignee: Achim Goepferich, Chris P. Lohmann
• Inventors: Lohmann, Chris P, Goepferich, Achim
• Application Number:
  US10/483,047
• Publication Number:
  US 20040176749A1
• Time in Patent Office: Days
• US Class Current: 604/891.1
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

The invention relates to an insert for the treatment of dry eyes, wherein the insert can be placed on or inserted into the lacrimal sac or the cornea.

Claims

1. Insert for the treatment of dry eye, wherein the insert can be inserted into the lacrimal sac or can be placed onto the cornea and in which proteins and/or peptides are embedded in a manner which allows their release into the eye, wherein the protein and/or peptide are, in particular, growth factors, preferably epidermal growth factor (EGF) and/or cytokine.

2. Insert according to claim 1, wherein the insert includes a matrix charged with proteins and/or peptides, wherein the proteins and/or peptides are preferably dissolved or suspended in the matrix.

3. Insert according to claims 1 or 2, wherein the proteins and/or peptides are present in the matrix in a stable form and can be released thereby in stable form.

4. Insert according to claims 2 or 3, wherein the matrix includes releasable calcium ions.

5. Insert according to any one of the claims 1 through 4, wherein the protein and/or peptides and/or the calcium ions can be dispensed in a linear function.

6. Insert according to any one of the claims 1 through 5, wherein the insert is made from one or a plurality of layers having different protein and/or peptide contents and/or matrix materials, wherein, in particular, protein and/or peptide-charged and protein and/or peptide-free layers are provided.

7. Insert according to any one of the claims 1 through 6, wherein the protein and/or peptide are bound to particles.

8. Insert according to any one of the claims 1 through 7, wherein the insert includes a reservoir which contains proteins and/or peptides with the reservoir being enclosed in a membrane, wherein, in particular, releasable calcium ions are present in addition to proteins and/or peptides.

9. Insert according to any one of the claims 1 through 8, wherein the release of the proteins and/or peptides is effected by means of an osmotic pump.

10. Insert according to any one of the claims 1 through 9, wherein the insert contains a micro chip which controls dispensing of the protein and/or peptide out of the reservoir.

11. Insert according to any one of the claims 1 through 10, wherein the insert includes an in-situ gel system which contains proteins and/or peptides which is liquid prior to use and which gels at the application location in response to pH values or a temperature change, wherein the in-situ gelling system in the solid state, in particular, forms a protein and/or peptide containing deposit and wherein, in particular, in addition to proteins and/or peptides, dischargeable calcium ions are also present.

12. Insert according to any one of the claims 1 through 11, wherein the insert has a round or oval cylindrical shape having a diameter r₁=0.1 to 20 mm and r₂=0.1 to 20 mm and a thickness D of between 1 μ

m to 5 mm.

13. Insert according to claim 12, wherein r₁=0.5 to 18 mm, r₂=0.5 to 10 mm and D=10 μ

m to 1 mm.

14. Insert according to any one of the claims 1 through 13, wherein the insert is degradable.

15. Manufacture of an insert according to anyone of the claims 1 through 14, wherein a water soluble gel is produced, in particular an alginate gel, which is mixed with a protein and/or peptide solution, in particular a growth factor solution and, in particular, an EGF solution and a protein and/or peptide charged film is formed which is dried with inserts subsequently being cut or punched out of the film.

16. Use of an insert according to any one of the claims 1 through 14 to dispense proteins and/or peptides, wherein these growth factors are, in particular, EGF and/or cytokine, wherein the dry eye, in particular, is caused by keratoconjunctivitis, Sjö

gren syndrome or meibomitis.