Compositions and methods for non-surgical treatment of ptosis

Abstract

Provided are pharmaceutical compositions, and methods of use of the compositions, for the non-surgical treatment of ptosis (eyelid droop). In one embodiment the composition includes oxymetazoline 0.1% formulated for topical administration to an eye. In one embodiment the composition includes a synergistic combination of oxymetazoline and phenylephrine, formulated for topical administration to an eye. Oxymetazoline alone causes no pupillary dilation (mydriasis), and a synergistic combination of oxymetazoline and phenylephrine induces no clinically significant mydriasis. In addition, to providing desirable cosmetic effects, the compositions and methods of the invention can improve visual fields otherwise compromised by ptosis.

1 - 40 . (canceled) 
     
     
         41 . A method of treating ptosis in a human patient, comprising administering oxymetazoline to the exterior surface of an eye of the patient, wherein the oxymetazoline is formulated as a pharmaceutical composition comprising about 0.05 to 0.1 weight percent oxymetazoline or a pharmaceutically acceptable salt thereof, wherein the composition does not include a preservative, wherein the patient does not have an allergic ocular condition calling for the treatment of the eye with oxymetazoline, does not have eyelid swelling, and has not undergone refractive eye surgery. 
     
     
         42 . The method of  claim 41 , wherein the pharmaceutical composition comprises about 0.1 weight percent oxymetazoline or a pharmaceutically acceptable salt thereof. 
     
     
         43 . The method of  claim 41 , wherein the oxymetazoline or a pharmaceutically acceptable salt thereof is a pharmaceutically acceptable salt of oxymetazoline. 
     
     
         44 . The method of  claim 43 , wherein the pharmaceutically acceptable salt of oxymetazoline is oxymetazoline hydrochloride. 
     
     
         45 . The method of  claim 44 , wherein the pharmaceutical composition comprises about 0.1 weight percent oxymetazoline hydrochloride based on the oxymetazoline component alone. 
     
     
         46 . The method of  claim 41 , wherein administering the oxymetazoline comprises administering the pharmaceutical composition from a squeeze bottle or dropper capable of delivering a single drop with a volume of about 0.1 to 0.35 mL. 
     
     
         47 . The method of  claim 46 , wherein the pharmaceutical composition comprises about 0.1 weight percent oxymetazoline or a pharmaceutically acceptable salt thereof. 
     
     
         48 . The method of  claim 46 , wherein administering the oxymetazoline further comprises providing a kit comprising the squeeze bottle or dropper and instructional materials directing administration of the pharmaceutical composition in a method for treating ptosis in a human patient. 
     
     
         49 . The method of  claim 48 , wherein the pharmaceutical composition comprises about 0.1 weight percent oxymetazoline or a pharmaceutically acceptable salt thereof. 
     
     
         50 . The method of  claim 46 , wherein the instructional materials direct administration of the pharmaceutical formulation as a single drop. 
     
     
         51 . The method of  claim 41 , wherein the pharmaceutical composition further comprises a lubricant. 
     
     
         52 . The method of  claim 51 , wherein the lubricant is selected from artificial tears, white petrolatum, and mineral oil. 
     
     
         53 . The method of  claim 41 , wherein the pharmaceutical composition further comprises a tear substitute. 
     
     
         54 . The method of  claim 53 , wherein the tear substitute is selected from polyols, cellulose derivatives, dextrans, water soluble proteins, carbomers, and gums. 
     
     
         55 . The method of  claim 54 , wherein the tear substitute is a cellulose derivative. 
     
     
         56 . The method of  claim 55 , wherein the tear substitute is hypromellose. 
     
     
         57 . The method of  claim 46 , wherein the squeeze bottle or dropper is a single-dose product.