Amniotic fluid topical formulation

Abstract

A human amniotic fluid formulation has been developed for topical application to the eye, which is useful for the treatment of ocular diseases and injuries including dry eyes, Sjogren's Syndrome, cataracts, burns and injuries to the eye tissues. The formulation is a sterile de-cellularized human amniotic fluid (D-HAF), devoid of amniotic stem cells and elements of micronized membrane or chorion particles. Methods for treating, or preventing various ocular diseases, injuries and disorders using the formulation, optionally in combination with one or more therapeutic, prophylactic or diagnostic agents are described.

1 . A method of treating, alleviating, or preventing a disorder, a disease, or an injury associated with the eye comprising administering to the eye an effective amount of a diluted sterile non-heated or ethidium bromide treated de-cellularized human amniotic fluid (D-HAF) to treat, alleviate, or prevent one or more symptoms associated with the eye. 
     
     
         2 . The method of  claim 1  wherein the D-HAF is devoid of amniotic stem cells, elements of micronized membrane, or chorion particles. 
     
     
         3 . The method of  claim 1  wherein the D-HAF contains over 300 human growth factors but less than unfiltered human amniotic fluid. 
     
     
         4 . The method of  claim 1  wherein the D-HAF is administered as a solution, suspension, ointment, spray, drops, or gel. 
     
     
         5 . The method of  claim 4  wherein the D-HAF is administered with an implant. 
     
     
         6 . The method of  claim 1  wherein the D-HAF is administered with a pharmaceutically acceptable carrier. 
     
     
         7 . The method of  claim 1  wherein the D-HAF is administered prior to, in conjunction with, subsequent to, or alternation with treatment with one or more therapeutic, prophylactic or diagnostic agents. 
     
     
         8 . The method of  claim 7  wherein the one or more therapeutic, prophylactic or diagnostic agents are selected from the group consisting of an anti-glaucoma agent, an anti-angiogenesis agent, an anti-infective agent, an anti-inflammatory agent, an analgesic agent, a local anesthetic, a growth factor, an immunosuppressant agent, an anti-allergic agent, an anti-oxidant, and a cytokine. 
     
     
         9 . The method of  claim 1  wherein the eye disorder is selected from the group consisting of dry eye disease, ocular burns, tears or injury to the eye or associated structures, corneal neovascular disorders, corneal, ocular blast injuries, eye infections, eye surgeries, drug-induced eye conditions, and prolonged redness and inflammation of the eye. 
     
     
         10 . The method of  claim 9  wherein the eye disorder is selected from the group consisting of amoebic keratitis, fungal keratitis, bacterial keratitis, viral keratitis, onchorcercal keratitis, bacterial keratoconjunctivitis, viral keratoconjunctivitis, corneal dystrophic diseases, Fuchs' endothelial dystrophy, Sjogren's syndrome, Stevens-Johnson syndrome, autoimmune dry eye diseases, environmental dry eye diseases, corneal neovascularization diseases, post-corneal transplant rejection, autoimmune uveitis, infectious uveitis, anterior uveitis, posterior uveitis, pan-uveitis, inflammatory disease of the vitreous or retina, endophthalmitis, macular edema, macular degeneration, age related macular degeneration, proliferative and non-proliferative diabetic retinopathy, hypertensive retinopathy, autoimmune disease of the retina, primary and metastatic intraocular melanoma or other intraocular metastatic tumors, open angle glaucoma, closed angle glaucoma, pigmentary glaucoma and combinations thereof. 
     
     
         11 . The method of  claim 1  wherein the eye disorder is injury, burn or abrasion of the cornea, cataracts or age related degeneration of the eye or vision associated therewith. 
     
     
         12 . The method of  claim 1  wherein the eye disorder is dry eye. 
     
     
         13 .- 18 . (canceled)