Changing Eye Color by Gene Transduction

Abstract

A person’s iris color can lighten, such as from brown to lighter brown, green, hazel, or blue, by introducing a melanocyte-killing agent through the cornea of the person’s eye and contacting the anterior surface of the iris with the agent at a dose sufficient to kill melanocytes in the iris stroma.

What is claimed is: 
     
         1 . A composition for changing a color of a subject’s iris of an eye, comprising:
 a sterile ophthalmic preparation comprising a genetic vector embedded or encapsulated in a delivery material, the genetic vector comprising:
 (a) a suicide gene; and 
 (b) a melanocyte-specific gene promoter operably linked to the suicide gene, wherein the composition is sufficient to kill melanocytes in a stroma of the subject’s iris of the eye without inducing visible inflammatory cells or flare in the anterior chamber of the eye. 
 
 
     
     
         2 . The composition of  claim 1 , wherein the genetic vector is selected from the group consisting of a plasmid, an adenovirus, an adeno-associated virus, and a lentivirus. 
     
     
         3 . The composition of  claim 1 , wherein the genetic vector comprises a recombinant adeno-associated virus. 
     
     
         4 . The composition of  claim 1 , wherein the preparation is in a powder form, and is reconstitutable with a fluid to form a sterile ophthalmic solution or suspension. 
     
     
         5 . The composition of  claim 1 , further comprising a biocompatible object configured to contact the preparation and sized to be placed in contact with a person’s iris. 
     
     
         6 . The composition of  claim 4 , wherein the biocompatible object comprises a disc, strip, or pledget. 
     
     
         7 . The composition of  claim 1 , wherein the suicide gene is selected from the group consisting of (i) a herpes simplex virus thymidine kinase gene; (ii) a cytosine deaminase gene; (iii) a nitroreductase gene; and (iv) a carboxypeptidase G2 gene. 
     
     
         8 . The composition of  claim 1 , wherein the melanocyte-specific gene promoter comprises a tyrosinase (Tyr) promoter. 
     
     
         9 . The composition of  claim 1 , wherein the suicide gene comprises a herpes simplex virus thymidine kinase (HSVtk) gene, and the melanocyte-specific gene promoter comprises a tyrosinase (Tyr) promoter. 
     
     
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         31 . The composition of  claim 1 , wherein the delivery material is flexible. 
     
     
         32 . The composition of  claim 1 , wherein the delivery material comprises a disc, strip, or pledget. 
     
     
         33 . The composition of  claim 32 , wherein the disc comprises a limbal guard around a periphery of the disc. 
     
     
         34 . The composition of  claim 32 , wherein the disc comprises a pupil guard around a periphery of a pupillary opening of the disc. 
     
     
         35 . The composition of  claim 1 , wherein the delivery material comprises a hydrogel. 
     
     
         36 . The composition of  claim 1 , wherein the sterile ophthalmic preparation is suitable for injection directly into the anterior chamber of the eye. 
     
     
         37 . A pharmaceutical composition for changing a color of a subject’s iris of an eye, comprising:
 a sterile ophthalmic preparation comprising a genetic vector embedded or encapsulated in a delivery material, the genetic vector comprising:
 (a) a suicide gene; and 
 (b) a melanocyte-specific gene promoter operably linked to the suicide gene, wherein the sterile ophthalmic preparation is sufficient to: change color of the subject’s iris of the eye and kill melanocytes in a stroma of the subject’s iris of the eye without inducing visible inflammatory cell or flare in the anterior chamber of the eye, after the pharmaceutical composition is injected directly into the anterior chamber of the eye. 
 
 
     
     
         38 . The pharmaceutical composition of  claim 37 , wherein the delivery material comprises a disc, strip, or pledget. 
     
     
         39 . The pharmaceutical composition of  claim 38 , wherein the disc comprises one or more of: a limbal guard around a periphery of the disc, and a pupil guard around a periphery of a pupillary opening of the disc. 
     
     
         40 . The pharmaceutical composition of  claim 37 , wherein the delivery material is flexible. 
     
     
         41 . The pharmaceutical composition of  claim 37 , wherein the delivery material comprises a hydrogel. 
     
     
         42 . The pharmaceutical composition of  claim 37 , wherein the sterile ophthalmic preparation is suitable for injection directly into the anterior chamber of the eye.