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(10) Patent No.: US 8455494 B2

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(10) Patent No.: US 8455494 B2 USOO8455494B2 (12) United States Patent (10) Patent No.: US 8,455,494 B2 Kaufman (45) Date of Patent: *Jun. 4, 2013 (54) PREPARATIONS AND METHODS FOR 5,153,205 A 10, 1992 Lotti AMELORATING OR REDUCING 5, 182,102 A 1/1993 DeSantis, Jr. et al. 5,229,127 A 7/1993 McKinzie PRESBYOPA 5,352,698 A 10, 1994 Santini 5,360,801 A 11/1994 Laties et al. (75) Inventor: Herbert E. Kaufman, Sarasota, FL (US) 5,384.243 A 1/1995 Gutkind et al. 5,422,116 A 6/1995 Yen et al. (73) Assignee: HEK Development, LLC, Sarasota, FL 5,459,133. A 10/1995 Neufeld (US) 5,459,140 A 10, 1995 Grammer 5,474,783 A 12/1995 Miranda et al. (*) Notice: Subject to any disclaimer, the term of this SE A 6.3% Built al. patent is extended or adjusted under 35 5,599,836 A 2f1997 Santini U.S.C. 154(b) by 0 days. 5,624,962 A 4/1997 Takeuchi et al. 5,656,286 A 8/1997 Miranda et al. This patent is Subject to a terminal dis- 5,677,327 A 10/1997 Gilet al. claimer. 5,679,713 A 10/1997 Hahnenberger 5,686,100 A 11, 1997 W11e et al. 5,688,510 A 11/1997 Nakamichi et al. (21) Appl. No.: 13/605.302 5,704,369 A 1/1998 Scinto et al. 5,773,466 A 6/1998 Santini (22) Filed: Sep. 6, 2012 5,776,916 A 7/1998 Gramer O O 5,811,446 A 9, 1998 Thomas (65) Prior Publication Data (Continued) US 2012/0329805 A1 Dec. 27, 2012 FOREIGN PATENT DOCUMENTS O O WO WO 2004 108135 12, 2004 Related U.S. Application Data WO WO 2005.115.375 12/2005 (63) Continuation of application No. 12/973,479, filed on (Continued) Dec. 20, 2010, now Pat. No. 8,299,079, which is a OTHER PUBLICATIONS continuation-in-part of application No. 12/785,734, filed on May 24, 2010, now abandoned. Miostat (MiostatDocument, 2008).* Kesler et al. (J Cataract Refract Surg 2004 30, 1707-1710).* (60) Provisional application No. 61/180,521, filed on May Adrenergic Agonists (Chapter 17, http://www.coursewareobjects. 22, 2009, provisional application No. 61/291,206, com/objects/evolve/E2/book pages/lehne/images/Ch17 filed on Dec. 30, 2009. Adrenergic Agonists.pdf. (2011), pp. 150-162. Agarwal, Refractive Surgery Nightmares, vol. 301, (2007), pp. 1-4. Alpha 1 Blocker (http://en.wikipedia.org/wiki/Alpha-1 blocker, (51) Int. C. (2011), pp. 1-3. A6 IK3I/498 (2006.01) Kesler et al. (J Cataract Refract Surg, 20, 2004, 1707-1710). A6IP27/02 (2006.01) Minims (Minims Pilocarpine Eye Drops, product information, 1999, (52) U.S. C. p. 1-4). USPC ............................ 514/249; 514/642: 514/912 Shiuey et al., “Cardiovascular Effects of Commonly Used Field of Classification Search Ophthalmic Medications.” Clin. Cardiol., vol. 19, (1996), pp. 5-8. (58) Tornqvist, “Effect of Topical Carbachol on the Pupil and Refraction CPC ....... A61K 31/498; A61 K9/0048 in Young and Presbyopic Monkeys.” Investigative Ophthalmology, USPC .................................................. 514/642, 912 See application file for complete search history. vol. 5, No. 2, (1966), pp. 186-195. Primary Examiner — Sreeni Padmanabhan (56) References Cited Assistant Examiner — Uma Ramachandran U.S. PATENT DOCUMENTS (74) Attorney, Agent, or Firm — Brinks Hofer Gilson & Lione 4,001,388 A 1, 1977 Shel1 4,008,719 A 2f1977 Theeuwes et al. 4,014,334 A 3, 1977 Theeuwes et al. (57) ABSTRACT 4,014,335 A 3, 1977 Arnold This application relates to the use of one or more parasym 4,115,544. A 9, 1978 Shell 4,136,173 A 1/1979 Pramoda et al. pathomimetic drugs in combination with one or more alpha 4,136,177 A 1/1979 Lin et al. agonists to create optically beneficial miosis to, for example, 4,136,178 A 1/1979 Lin et al. temporarily treat presbyopia. The invention provides a phar 4,186,184 A 1, 1980 Zaffaroni maceutical preparation comprising atherapeutically effective 4,271,143 A 6, 1981 Schoenwald et al. amount of one or more parasympathomimetic drugs or cho 4,407,792 A 10, 1983 Schoenwald et al. 4.459,309 A 7, 1984 Chiou linesterase inhibitors, or a pharmaceutically acceptable salt 4.474,751 A 10, 1984 Haslam et al. thereof, in combination with one or more alpha agonists or 4,652,571 A 3/1987 Croom, Jr. et al. antagonists, or a pharmaceutically acceptable salt thereof. 4,661.509 A 4, 1987 Gordon et al. The invention further provides for a method for treating, 4,668,506 A 5, 1987 Bawa ameliorating or reducing presbyopia of a patient having an 4,713,244. 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