Gamma-polyglutamic acid-based ocular irrigating solutions

Abstract

Ophthalmic irrigating solutions are disclosed. The ophthalmic irrigating solution comprises: a) γ-polyglutamic acid (γ-PGA) and/or salt thereof in an amount effective to increase the viscosity of the irrigating solution; and b) an ophthalmically acceptable aqueous vehicle for the γ-PGA and/or salt thereof. Also disclosed is a method of irrigating ocular tissues of a patient, in which the method comprises introducing to the ocular tissues of the patient an ophthalmic irrigating solution comprising γ-PGA) and/or salt thereof in an amount sufficient to irrigate the ocular tissues of the patient.

1 . A method of irrigating ocular tissues of a patient, comprising:
 introducing to the ocular tissues of the patient an ophthalmic irrigating solution in an amount sufficient to irrigate the ocular tissues of the patient, the solution comprising:   (a) γ-polyglutamic acid (γ-PGA) and/or salt thereof in an amount effective to increase the viscosity of the solution; and   (b) an ophthalmically acceptable aqueous vehicle for the γ-PGA and/or salt thereof.   
     
     
         2 . The method of  claim 1 , wherein the irrigating solution has a viscosity of 0.32 to 50, or 0.32 to 30, or 0.32 to 3.93 centipoise. 
     
     
         3 . The method of  claim 1 , wherein the irrigating solution has an osmolarity of 290 to 320 mOsm per Liter. 
     
     
         4 . The method of  claim 1 , wherein the irrigating solution does not contain cross-linked polyglutamic acid and has no additional polyamino acid or polymer. 
     
     
         5 . The method of  claim 1 , wherein the irrigating solution has a refractive index of 1.330 to 1.344. 
     
     
         6 . The method of  claim 1 , wherein the ophthalmically acceptable aqueous vehicle comprises a balanced salt solution containing electrolytes, a buffer and an energy source. 
     
     
         7 . An ophthalmic irrigating solution comprising:
 (a) γ-polyglutamic acid (γ-PGA) and/or salt thereof in an amount effective to increase the viscosity of the irrigating solution; and   (b) an ophthalmically acceptable aqueous vehicle for the γ-PGA and/or salt thereof.   
     
     
         8 . The ophthalmic irrigating solution of  claim 7 , wherein the irrigating solution has a viscosity of 0.32 to 50, or 0.32 to 30, or 0.32 to 3.93 centipoise. 
     
     
         9 . The ophthalmic irrigating solution of  claim 7 , wherein the irrigating solution has an osmolarity of 290 to 320 mOsm per Liter. 
     
     
         10 . The ophthalmic irrigating solution of  claim 7 , wherein the irrigating solution has a refractive index of 1.330 to 1.344. 
     
     
         11 . The ophthalmic irrigating solution of  claim 7 , wherein the irrigating solution does not contain cross-linked polyglutamic acid and has no additional polyamino acid or polymer. 
     
     
         12 . The ophthalmic irrigating solution of  claim 7 , wherein the ophthalmically acceptable aqueous vehicle comprises a balanced salt solution containing electrolytes, a buffer and an energy source. 
     
     
         13 . The ophthalmic irrigating solution of  claim 7 , wherein the γ-PGA has a molecular weight of 10,000 to 2,000,000 Daltons, or 1,000,000 to 2,000,000 Daltons. 
     
     
         14 . A pharmaceutical kit comprising:
 (a) an ophthalmic irrigating solution according to  claim 7 ; and   (b) an a package insert containing printed instructions for irrigating ocular tissues of a patient.   
     
     
         15 . A method of reducing stress-induced damage to ocular tissues of a patient during eye surgery, comprising:
 introducing to the ocular tissues of the patient during the eye surgery an ophthalmic irrigating solution in an amount sufficient to irrigate the ocular tissues of the patient, the irrigating solution comprising:   (a) γ-polyglutamic acid (γ-PGA) and/or salt thereof in an amount effective to increase the viscosity of the solution; and   (b) an ophthalmically acceptable aqueous vehicle for the γ-PGA and/or salt thereof.   
     
     
         16 . The method of  claim 15 , wherein the eye surgery includes surgical vitrectomy, cataract extraction, lens aspiration, anterior segment reconstruction and phacoemulsification. 
     
     
         17 . The method of  claim 1 , wherein the irrigating solution has a viscosity of 0.32 to 3.93 centipoise. 
     
     
         18 . The ophthalmic irrigating solution of  claim 7 , wherein the irrigating solution has a viscosity of 0.32 to 3.93 centipoise. 
     
     
         19 . The ophthalmic irrigating solution of  claim 7 , wherein the ophthalmically acceptable aqueous vehicle further comprises an antioxidant. 
     
     
         20 . The ophthalmic irrigating solution of  claim 8 , wherein the irrigating solution has an osmolarity of 290 to 320 mOsm per Liter.