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 - 29 . (canceled) 
     
     
         30 . A pharmaceutical composition formulated for topical ophthalmic administration, comprising 0.1 weight percent oxymetazoline hydrochloride. 
     
     
         31 - 40 . (canceled) 
     
     
         41 . The pharmaceutical composition of  claim 30 , wherein the composition does not include a preservative. 
     
     
         42 . The pharmaceutical composition of  claim 30 , further comprising a lubricant. 
     
     
         43 . The pharmaceutical composition of  claim 42 , wherein the lubricant is selected from artificial tears, white petrolatum, or mineral oil. 
     
     
         44 . The pharmaceutical composition of  claim 30 , further comprising a tear substitute. 
     
     
         45 . The pharmaceutical composition of  claim 44 , wherein the tear substitute is selected from a polyol, a cellulose derivative, a dextran, a water soluble protein, a carbomer, or a gum. 
     
     
         46 . The pharmaceutical composition of  claim 45 , wherein the cellulose derivative is hypromellose. 
     
     
         47 . The pharmaceutical composition of  claim 30 , wherein the pH of the composition is from 4.0 to 8.0. 
     
     
         48 . A squeeze bottle or dropper comprising the pharmaceutical composition of claim  1 , wherein the squeeze bottle or dropper is capable of delivering one or more single drops, each drop having a volume of about 0.01 to 0.035 mL. 
     
     
         48 . The squeeze bottle or dropper of  claim 48 , wherein each single drop comprises from about 0.01 mg to about 0.035 mg of oxymetazoline hydrochloride. 
     
     
         49 . A squeeze bottle or dropper comprising the pharmaceutical composition of  claim 30 , wherein the squeeze bottle or dropper is configured to deliver an amount of the composition of  claim 30  which is therapeutically effective to increase eyelid separation without dilating pupils. 
     
     
         50 . The squeeze bottle or dropper of  claim 49 , wherein the amount is from about 0.01 mg to about 0.035 mg of oxymetazoline hydrochloride. 
     
     
         51 . A squeeze bottle or dropper comprising a deliverable dose of the composition of  claim 30 , wherein the deliverable dose is from about 0.01 mg to about 0.035 mg of oxymetazoline hydrochloride. 
     
     
         52 . A pharmaceutical composition formulated for topical ophthalmic administration comprising 0.1 weight percent oxymetazoline hydrochloride and an ophthalmologically acceptable carrier. 
     
     
         53 . The pharmaceutical composition of claim  54 , wherein the pH of the composition is from 4.0 to 8.0.