COMPOSITIONS AND METHODS FOR THE TREATMENT OF EYE CONDITIONS
The present invention is directed to compositions for and methods for the treatment of presbyopia, irregular astigmatism, and/or refractive error comprising from about 0.1% to about 4.0% w/w of a muscarinic agonist and from about 0.07% to about 0.15% w/w brimonidine.
1 . A method of enhancing duration of presbyopia treatment comprising administering from about 0.1% to about 4.0% w/w of a muscarinic agonist concurrently or sequentially with from about 0.07% to about 0.15% w/w brimonidine to a subject in need of presbyopia treatment, wherein w/w denotes weight by total weight of a composition.
2 . The method of claim 1 , wherein the muscarinic agonist is selected from the group consisting of aceclidine, pilocarpine, carbachol and a combination thereof.
3 . The method of claim 1 , wherein the muscarinic agonist is aceclidine at a concentration from about 0.3% to about 2.5% w/w.
4 . The method of claim 1 , wherein the muscarinic agonist is pilocarpine at a concentration from about 0.3% to about 2.5% w/w.
5 . The method of claim 1 , wherein the muscarinic agonist is carbachol at a concentration from about 1% to about 4% w/w.
6 . The method of claim 1 , wherein brimonidine is at a concentration from about 0.07% to about 0.09% w/w.
7 . The method of claim 1 , wherein each of the muscarinic agonist and brimonidine are administered in a composition having a pH below about 6.0.
8 . The method of claim 1 , wherein an eye of the subject in need of presbyopia treatment has a pupil diameter of below about 2.0 millimolar for about 10 or more hours.
9 . A method enhancing duration of presbyopia treatment comprising administering from about 0.3% to about 2.0% w/w aceclidine concurrently or sequentially with from about 0.07% to about 0.15% w/w brimonidine to a subject in need of presbyopia treatment, wherein w/w denotes weight by total weight of a composition.
10 . The method of claim 9 , wherein aceclidine and brimonidine are administered via a single composition.
11 . The method of claim 10 , wherein the single composition further comprises one or more excipients selected from the group consisting of one or more nonionic surfactants and one or more viscosity agents.
12 . The method of claim 11 , wherein the one or more nonionic surfactants are selected from the group consisting of a polysorbate, tyloxapol, a poloxamer, a cyclodextrin, octoxynol 40, vitamin E TPGS, a polyoxyl castor oil, a polyoxyl stearate, polyethylene glycol, a polyoxyethylene glycol alkyl ether and 2-[[10,13-dimethyl-17-(6-methylheptan-2-yl)-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl]oxy] ethanol.
13 . The method of claim 12 , wherein the one or more nonionic surfactants is polysorbate 80.
14 . The method of claim 11 , wherein the one or more viscosity agents are selected from the group consisting of a cellulose derivative, hyaluronate, a carbomer polyvinyl chloride, polyvinyl pyrrolidone and a gum.
15 . The method of claim 14 , wherein the one or more viscosity agents is carboxymethyl cellulose or hydroxypropylmethyl cellulose.
16 . A method of enhancing duration of presbyopia treatment comprising administering from about 1% to about 2% w/w aceclidine concurrently or sequentially with from about 0.07% to about 0.09% w/w brimonidine to a subject in need of presbyopia treatment, wherein w/w denotes weight by total weight of a composition.
17 . The method of claim 16 , wherein brimonidine is at a concentration of about 0.08% w/w.
18 . The method of claim 16 , wherein aceclidine and brimonidine are administered via a single composition.
19 . The method of claim 18 , wherein the single composition has a pH below about 6.0.
20 . The method of claim 18 , wherein the single composition further comprises from about 2% to about 5% w/w polysorbate 80 and from about 1.25% to about 1.40% w/w carboxymethyl cellulose or hydroxypropylmethyl cellulose.