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Muscarinic Antagonists in the Treatment of Presbyopia

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Muscarinic Antagonists in the Treatment of Presbyopia Europäisches Patentamt *EP001100480B1* (19) European Patent Office Office européen des brevets (11) EP 1 100 480 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.7: A61K 31/00, A61K 31/551, of the grant of the patent: A61K 31/5513, A61K 31/4178, 24.09.2003 Bulletin 2003/39 A61K 31/27, A61K 31/221, (21) Application number: 99937295.6 A61K 31/341, A61K 31/4453, A61K 31/695, A61K 31/452, (22) Date of filing: 22.07.1999 A61P 27/10 (86) International application number: PCT/US99/16260 (87) International publication number: WO 00/006135 (10.02.2000 Gazette 2000/06) (54) MUSCARINIC ANTAGONISTS IN THE TREATMENT OF PRESBYOPIA MUSKARINISCHE ANTAGONISTEN ZUR BEHANDLUNG VON PRESBYOPIE ANTAGONISTES MUSCARINIQUES UTILES DANS LE TRAITEMENT DE LA PRESBYTIE (84) Designated Contracting States: • A. SUZUMURA ET AL.: "Accomodation in AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU Presbyopics Influenced by Aging and Extensive MC NL PT SE Medication" NIPPON GANKA KIYO. FOLIA OPHTHALMOLOGICA JAPONICA. BULLETIN OF (30) Priority: 30.07.1998 US 126064 JAPANESE OPHTHALMOLOGY, vol. 22, no. 1, 1971, pages 15-24, XP000866355 (43) Date of publication of application: • ICHIKAWA H: "A study on the effects of 23.05.2001 Bulletin 2001/21 pilocarpine in low concentration on various ophthalmic functions especially on the AC-A (73) Proprietor: Allergan, Inc. ratio." NIPPON GANKA KIYO. FOLIA Irvine, CA 92612 (US) OPHTHALMOLOGICA JAPONICA. BULLETIN OF JAPANESE OPHTHALMOLOGY, (1971 APR) 22 (72) Inventors: (4) 240-59. , XP000866560 • GWON, Arlene • ABRAMSON, DAVID H. ET AL: "Pilocarpine in Newport Beach, CA 92660 (US) the presbyope. Demonstration of an effect on the • WOLDE MUSSIE, Elizabeth anterior chamber and lens thickness" ARCH. Laguna Niguel, CA 92677 (US) OPHTHALMOL. (1973), 89(2), 100-2 , XP000866126 (74) Representative: HOFFMANN - EITLE • G. TÖRNQVIST: "Effect of topical carbachol on Patent- und Rechtsanwälte the pupil and refraction in young and presbyopic Arabellastrasse 4 monkeys" INVESTIGATIVE OPHTHALMOLOGY, 81925 München (DE) vol. 5, no. 2, 1966, pages 186-195, XP000870258 • ESKRIDGE J B: "Review of ciliary muscle effort (56) References cited: in presbyopia." AMERICAN JOURNAL OF EP-A- 0 369 880 WO-A-90/15604 OPTOMETRY AND PHYSIOLOGICAL OPTICS, WO-A-94/01096 US-A- 5 441 937 (1984 FEB) 61 (2) 133-8. , XP000866125 • "The Merck Index" 1996 , MERCK & CO., INC. , WHITEHOUSE STATION, NJ XP002128588 page 64 page 283 page 535 page 1652 -page 1653 Alverine, Camylofine, Dihexyverine, Trimebutine Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 100 480 B1 Printed by Jouve, 75001 PARIS (FR) (Cont. next page) EP 1 100 480 B1 • BITO L Z ET AL: "Age-dependent loss of accommodative amplitude in rhesus monkeys: an animal model for presbyopia." INVESTIGATIVE OPHTHALMOLOGY AND VISUAL SCIENCE, (1982 JUL) 23 (1) 23-31. , XP000866173 2 EP 1 100 480 B1 Description [0001] Presbyopia, occurring after middle age, is the inability of an eye to focus correctly. This age-related ocular pathology manifests itself in a loss of accommodative ability. Accommodative ability is the capacity of the eye, through 5 the lens, to focus on near or far objects by changing the shape of the lens to become more spherical, or convex. [0002] The ciliary muscle controls the shape of the lens through suspended suspensory ligaments called zonules. Like most smooth muscles, the ciliary muscle has a dual innervation, receiving both sympathetic and parasympathetic fibers. [0003] In the ciliary muscle, the contraction necessary for accommodation is under parasympathetic or cholinergic 10 control. While this parasympathetic control is predominant, sympathetic, or adrenergic, innervation opposes the cholin- ergic control and plays a lesser role in enabling relaxation of the ciliary muscle. [0004] Most current theories of accommodation assume that the condition of physiological rest of accommodation occurs when the emmetropic eye focuses on a distant target, demanding good resolution. The fact that the optical value for the location of this distant target can be stated as zero diopters from the eye has tended to perpetuate the 15 concept that active accommodation is unidirectional toward a near object. [0005] However, if one considers that if the normal stimulus to accommodation is visual in nature, then the resting state of the eye must be determined by removing all visual stimuli, as for example, in complete darkness or in a luminous but completely empty visual field. This state of rest of the eye has been called "tonic accommodation", "space myopia" and "sky myopia", and averages about 1D in extremely low illumination or total darkness but may be as high as 2D 20 myopia. [0006] This implies that the resting state of accommodation is present when the eye is focused for objects about one meter away. Accordingly, distant objects would be focused on the retina by an active negative accommodation and near objects would be focused by an active positive accommodation. [0007] Accordingly, in the natural resting state of the eye, the parasympathetic/cholinergic system maintains ciliary 25 muscle tone, i.e., the ciliary muscle is contracted and zonular tension is relaxed such that the lens is more spherical and in a forward position increasing the refractive power of the eye. Thus, the eye is naturally in a "tonic accommodative" state and with appropriate stimulus is capable of further active positive accommodation as well as active negative accommodation. [0008] The mechanism of presbyopia and the age dependent loss of accommodative amplitude was studied in ES- 30 KRIDGE J B: "Review of ciliary muscle effort in presbyopia". AMERICAN JOURNAL OF OPTOMETRY AND PHYSI- OLOGICAL OTPICS (1984), 61(2), 133-138, and BITOLZETAL:"Age-dependent loss of accommodative amplitude in rhesus monkeys: an animal model for presbyopia." INVESTIGATIVE OPHTHALMOLOGY AND VISUAL SCIENCE (1982), 23(1), 23-31. [0009] The effect of muscarinic agonists, such as pilocarpine and carbachol was studied in A. SUZUMURA ET AL.: 35 "Accommodation in Presbyopics Influenced By Aging and Extensive Medication" NIPPON GANKA KIYO. FOLIA OP- THALMOLOGICA JAPANICA. BULLETIN OF JAPANESE OPHTHALMOLOGY (1971), 22(1), 15-24; ICHIKAWA H: "A study on the effects of pilocarpine in low concentration on various ophthalmic functions especially on the AC-A ratio." NIPPON GANKA KIYO. FOLIA OPTHALMOLOGICA JAPANICA. BULLETIN OF JAPANESE OPHTHALMOLOGY (1971), 22(4), 240-59; ABRAMSON, DAVID H. ET AL: "Pilocarpine in the presbyope. Demonstration of an effect on 40 the anterior chamber and lens thickness" ARCH. OPHTHALMOL. (1973), 89(2), 100-102; and G. TÖRNQVIST: "Effect of topical carbachol on the pupil and refraction in young and presbyopic monkeys" INVESITAGTIVE OPTHALMOLOGY (1966), pages 186-195. SUMMARY OF THE INVENTION 45 [0010] The present invention provides for the use of a muscarinic receptor antagonist for the manufacture of a med- icament for the treatment of presbyopia by increasing or decreasing parasympathetic/cholinergic/ciliary tonic contrac- tion in order to restore the resting Position of the eye and allow normal positive and negative accommodation. This action of the ciliary muscle under parasympathetic innervation provides for zonules relaxation which allows the lens 50 to assume a more spherical shape. [0011] The antagonist is administered in a pharmaceutically acceptable ophthalmic formulation, preferably the an- tagonist is administered topically by application of the formulation to the eye in a nonirritating sterile solution or sus- pension. In that regard, the formulation is preferably at a pH compatible with the eye. More particularly, in accordance with the present invention, a muscarinic agent may be selected to act on various M receptors of the ciliary muscle. 55 DETAILED DESCRIPTION [0012] While not limiting the treatment of this invention to the validity of one proposed mechanism of action, it is 3 EP 1 100 480 B1 believed that the action of circular fibers of the ciliary muscle causes relaxation of the zonules and allows greater curvature or sphericity of the lens. The radial/longitudinal fibers of the ciliary muscle relax, or stretch, which allows the lens to move forward. However, as the lens continues to grow throughout life, its increased size and concomitant loss of elasticity exceeds the capability of the ciliary muscle to effect a proper accommodation change. In addition, the 5 resting state of the eye is also expected to change. [0013] In addition, aging studies on the brain have demonstrated a loss of function of the cholinergic system that is due to a decline in the neurotransmitter substance acetylcholine. This is probably due to a decreased production by the enzyme cholineacetyl transferate (CHAT) or acetylcholine synthetase as there is no decline in cholinergic receptor cells with age. That is, the ciliary muscle has the same number of receptors and the contractile ability of the muscle is 10 the same in young and old individuals. [0014] In accordance with the present invention, muscarinic receptor subtypes enable selective contraction or re- laxation of the circular or longitudinal fibers of the ciliary muscle by action on the M1 - M5 receptors. [0015] A summary of receptor subtypes is given in Table 1. 15 TABLE 1 Receptor subtype Tissue or cellular function Signaling mechanisms M1 Contraction or secretion PI, Ca M2 Relaxation CAMP 20 M3 Contraction or secretion PI, Ca M4 Relaxation cAMP M5 Contraction or secretion PI, Ca Where 25 PI Phosphoinositide hydrolysis (stimulatory response) Ca Increase in intracellular free calcium (stimulatory response) cAMP Increase in cyclic adenosine monophosphate (AMP) formation (inhibitory response) 30 [0016] The M3 receptor subtype is the most common and is seen predominantly in the circular fibers and the M5 receptor is predominant in the longitudinal fibers.
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