Claims for Patent: 9,844,537

Summary for Patent: 9,844,537

Title:	Compositions and methods for the treatment of presbyopia
Abstract:	The invention provides compositions and methods for the treatment of presbyopia. The compositions preferably comprise aceclidine and a polyol. The compositions optionally contain a cycloplegic agent, a surfactant, a viscosity enhancer, an osmolarity modifier and a preservative.
Inventor(s):	Gerald Horn, Lee Nordan
Assignee:	Lenz Therapeutics Operations Inc
Application Number:	US15/073,089
Patent Claims:	1. An ophthalmological composition for the treatment of presbyopia comprising: an active agent consisting of from about 0.25% to about 2.0% w/v aceclidine; and a polyol, wherein w/v denotes weight by volume. 2. The ophthalmological composition according to claim 1, wherein the polyol is mannitol at a concentration from about 1.0% to about 10.0% w/v. 3. The ophthalmological composition according to claim 2, further comprising a nonionic surfactant. 4. The ophthalmological composition according to claim 3, wherein the nonionic surfactant is selected from the group consisting of a polysorbate, a polyoxyl castor oil, a polyoxyl stearate, a poloxamer, a polyethylene glycol, a polyoxyethylene glycol alkyl ether, tyloxapol 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. 5. The ophthalmological composition according to claim 4, wherein the nonionic surfactant is polysorbate 80 or polyoxyl 35 castor oil. 6. The ophthalmological composition according to claim 5, wherein the nonionic surfactant is polysorbate 80 at a concentration from about 0.5% to about 10.0% w/v. 7. The ophthalmological composition according to claim 3, further comprising a viscosity enhancer. 8. The ophthalmological composition according to claim 7, wherein the viscosity enhancer is selected from the group consisting of a cellulose derivative, hyaluronate, a carbomer and a gum. 9. The ophthalmological composition according to claim 8, wherein the viscosity enhancer is at a concentration from about 1.0% to about 2.0% w/v and wherein w/v denotes weight by volume and wherein initial viscosity of the composition is from about 25 to about 10,000 centipoise. 10. The ophthalmological composition according to claim 7, further comprising a preservative selected from the group consisting of benzalkonium chloride, sorbic acid, oxychloro complex and a combination thereof. 11. An ophthalmological composition for the treatment of presbyopia comprising: about 1.65% to about 1.80% w/v aceclidine; and about 2.0% to about 3.0% w/v polyol, wherein w/v denotes weight by volume. 12. The ophthalmological composition of claim 11 further comprising about 2.0% to about 6.0% w/v nonionic surfactant. 13. The ophthalmological composition of claim 12 further comprising about 0.5% to about 2.0% w/v viscosity enhancer. 14. The ophthalmological composition of claim 13 further comprising about 0.004% to about 0.007% w/v cycloplegic agent. 15. An ophthalmological composition for the treatment of presbyopia comprising: about 1.75% w/v aceclidine as the sole active agent; and about 2.5% w/v mannitol, wherein w/v denotes weight by volume. 16. The ophthalmological composition of claim 15 further comprising one or more excipients selected from the group consisting of about 0.50% w/v sodium chloride, about 0.02% w/v benzalkonium chloride, about 0.10% w/v sorbate, about 0.01% w/v ethylenediaminetetraacetic acid (EDTA) and 0.10% w/v citric acid. 17. A method of treating presbyopia comprising administering to a subject in need thereof the ophthalmological composition of claim 1. 18. A method of treating presbyopia comprising administering to a subject in need thereof the ophthalmological composition of claim 15, wherein near vision acuity of the subject is improved by at least 3 lines of resolution for at least 6 hours. 19. A method of treating irregular astigmatism, keratoconic ectasia, and low myopia, or hyperopia, with or without astigmatism, comprising administering to a subject in need thereof the ophthalmological composition of claim 1.