Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
MACUMAX™ A powerful combination of nutrients for eye health Sami Direct I Confidential I www.samidirect.com 1 • MACUMAX™ is a combinatorially additive combination of nutrients that are scientifically reported to play a significant role in the management of Eye Health. • It provides nutrition to improve the eye health. • Reduces risk of vision loss from age-related Macular Degeneration (AMD), cataracts and related eye disorders. • It provides an antioxidant system with a strong focus on ocular health management. Sami Direct I Confidential I www.samidirect.com 2 AMD: Age related Macular Degeneration Age related macular degeneration (AMD) is the disorder of the macular area, most often clinically apparent after 50 years of age, characterised by: •discrete whitish-yellow spots identified as drusen (an aggregation of hyaline material). •increased pigment or hyperpigmentation associated with drusen. •sharply demarcated areas of depigmentation or hypopigmentation of the retinal pigment epithelium and associated drusen. Sami Direct I Confidential I www.samidirect.com Copyright 2001 Lippincott Williams & Wilkins 2 3 Hard Drusen http://medweb.bham.ac.uk/easdec/eyetextbook/AMD/armd.htm Confluent drusen http://medweb.bham.ac.uk/easdec/eyetextbook/AMD/armd.htm Sami Direct I Confidential I www.samidirect.com Calcified drusen Millodot: Dictionary of Optometry and Visual Science, 7th edition. © 2009 Butterworth-Heineman Large drusen http://www.cvr.org.au/armd.htm 4 Cataract • Cataracts are developmental or degenerative opacities of the lens that result in a gradual, painless loss of vision. • Oxidative insult appears to be a precipitating factor in cataracts, resulting in the development of insoluble, oxidized lens proteins. • Higher levels of hydrogen peroxide have been found in cataractous lenses compared to normal lenses, indicating oxidative stress. Horton J. Harrisons Principles of Internal Medicine. 14th ed. New York, NY: McGraw-Hill; 1998:168. Spector A, Garner WH. Exp Eye Res 1981;33:673-681 Sami Direct Direct II Confidential Confidential II www.samidirect.com www.samidirect.com Sami 5 Retinitis Pigmentosa • Retinitis pigmentosa (RP) is a rare, inherited, degenerative disease characterized by atrophy of the light-sensing rods in the retina. Retinitis pigmentosa • A progressive loss of peripheral vision occurs over time, resulting in tunnel vision in late stages of the disease. Berson EL. Int Ophthalmol Clin 2000;40:93-111. Image: http://www.rpfightingblindness.org.uk Sami Direct I Confidential I www.samidirect.com Normal macula 6 • Provides optimum nutrition to the eyes to maintain proper functioning • Antioxidant activity helps prevent damage from harmful effects of free-radicals • Enhances visual performance by reducing disability and discomfort from glare • Helps to enhance contrast and reduce photo-stress recovery times • Safe for use in different infective and inflammatory ophthalmic conditions Sami Direct I Confidential I www.samidirect.com 7 1. 2. 3. 4. Ingredients ZeaLutein® Mirtoselect® Zinc Monomethionine Saffron extract ZeaLutein® is a Trademark registered product of Sabinsa Corporation Mirtoselect® is a Trademark registered product of Indena S.p.A, Italy Sami Direct I Confidential I www.samidirect.com 8 Sami Direct I Confidential I www.samidirect.com 9 ® Sami Direct I Confidential I www.samidirect.com 10 ZeaLutein® • ZeaLutein® granules is a proprietary composition of 1% Zeaxanthin, 5% Lutein and 2% Piperine, blended in a ratio optimized to provide benefits in eye health. • The three ingredients are naturally sourced from Tagetes erecta, Lycium barbarum and Piper nigrum respectively. Japan US Patent 6,689,400 Sami Direct I Confidential I www.samidirect.com Patent 4,227,409 11 Zeaxanthin and Lutein • Zeaxanthin is a stereoisomer of lutein, differing only in the location of a double bond in one of the hydroxyl groups. • The hydroxyl groups appear to control the biological function of these two xanthophylls. Zeaxanthin Lutein Sami Direct I Confidential I www.samidirect.com 12 Uniqueness of the composition Ratio of Zeaxanthin to Lutein 1:5 in Zealutein is the same as that observed in the human plasma. Sami Direct I Confidential I www.samidirect.com 13 Dual function in the Eye Lutein and Zeaxanthin are the only carotenoids found in both the macula and lens of the human eye, and have dual functions in both tissues : • To act as powerful antioxidants • To filter high-energy blue light Sami Direct I Confidential I www.samidirect.com 14 Reported Clinical studies for AMD Place of study Dosage No. of individuals Observations Reference Chicago 10mg Lutein 90 males with atrophic AMD 36% increase in Macular Pigment Density (MPD) in the lutein group Richer S et al., Optometry, 2004 Italy 15mg Lutein 50 patients with AMD Two-fold increase in visual acuity Massacesi AL et al., Ass Res Vision Ophthalmol 2001 Miami 2.4–30 mg/d Lutein, 30 mg/d of Zeaxanthin 8 subjects Increases in the serum concentration of lutein and zeaxanthin Richard A et al., The J of Nutrition 2002 United States 6 mg/day lutein / zeaxanthin 356 subjects Fifty seven percent decreased risk for AMD Seddon JM, JAMA 1994 Ireland 3.7 mg/d lutein, 0.8 mg/d of zeaxanthin 10 subjects Significant increases in Macular Pigment Optical Density Eithne E C et al., Current Eye Research. 2010 Sami Direct I Confidential I www.samidirect.com 15 Studies on Cataract • The Nurses Health Study examined the effect of 12 years of carotenoid consumption (dietary intake) on the risk of cataract formation in 77,466 female nurses, ages 45 and over. • Nurses in the highest quintile for lutein and zeaxanthin consumption had a 22-percent decreased risk for cataract extraction, compared with those in the lowest quintile. Chasen-Taber L, Willett WC, Seddon JM, et al. Am J Clin Nutr 1999;70:509-516. Sami Direct I Confidential I www.samidirect.com 16 Studies on Cataract • A double-blind trial on carotenoid supplementation and agerelated cataracts measured visual acuity, glare sensitivity, and serum carotenoid levels in 17 clinically diagnosed patients. • Patients received 15 mg lutein three times weekly for two years and were compared to patients receiving 100 mg alphatocopherol or placebo for the same period. • In patients receiving lutein, statistically significant improvements in visual acuity and glare sensitivity and increased serum concentrations of lutein were observed, compared to the alpha-tocopherol and control patients. Olmedilla B, Granado F, Blanco I, Vaquero M. Nutrition 2003;19:21-24. Image: www.bausch.com Sami Direct Direct II Confidential Confidential II www.samidirect.com www.samidirect.com Sami 17 Studies on Retinitis Pigmentosa Dagnelie et al found 40 mg lutein daily for nine weeks significantly improved visual acuity among 16 Retinitis Pigmentosa patients. Dagnelie G, Zorge IS, McDonald TM. Optometry 2000;71:147-164. Sami Direct I Confidential I www.samidirect.com 18 ® Sami Direct I Confidential I www.samidirect.com 19 Mirtoselect® • MIRTOSELECT® is the authentic bilberry extract obtained from Vaccinium myrtillus L. berries. • It is characterized by a very specific HPLC profile and is standardized to contain ≥36% anthocyanins (anthocyanosides) by HPLC (equivalent to 25% anthocyanidins by UV). • The major applications investigated so far for MIRTOSELECT® are in the realms of vascular health and retinal health. Indena Patents: US0046215A1, WO090085A1, EP2252285A1, CN101951899B, US0244961A1 Sami Direct I Confidential I www.samidirect.com 20 Bilberry extract • Bilberry Extract has – the ability to improve oxygen and blood delivery to the eye – to scavenge free radicals that can disrupt collagen structures and contribute to conditions such as cataracts and macular degeneration. • It provides significant development of glaucoma. protection against the • Bilberry anthocyanosides are recognized as highly effective in preventing diabetic retinopathy. Sami Direct I Confidential I www.samidirect.com 21 Mirtoselect® and eyesight fatigue • Crossover, double-blind, placebo-controlled study on 20 patients • Improvement in subjective symptoms like the occurrence of vision sparks (80% of subjects), eyesight dimming (73% of subjects) and ocular fatigue (70% of subjects) in computer operators. • Flicker values improved significantly, and an overall improvement of eye fatigue could be established. Kajimoto O. Clinical Evaluation of the Oral Administration of Vaccinium Myrtillus Anthocyanosides (VMA) in Mental Fatigue and Asthenopia. Scientific Report Collection 1998, 19, 143-150 Sami Direct I Confidential I www.samidirect.com 22 Effect of Mirtoselect® on the improvement of symptoms associated with eyesight fatigue when compared to a placebo group. Sami Direct I Confidential I www.samidirect.com 23 Mirtoselect® and healthy eyesight • An 8-weeks trial with a daily dosage of Mirtoselect® was carried out on 63 school children. • Supports ocular health related to increased eye accommodation associated with prolonged reading and computer work. • Shows affinity for small blood vessels, improves the blood flow in the eye bulb tissues and activates the nutrition supply. • Maintains healthy synthesis of retinal rhodopsin and attenuate free radicals. Kajimoto S. Recovery effect of VMA intake on visual acuity of pseudomyopia in primary school students. J. New Rem. Clin. 2000, 49, 72-79. Tirupula K.C. pH-dependent interaction of rhodopsin with cyanidin-3-glucoside.2. Functional aspects. Photochem. Photobiol. 2009, 8 (2), 463-70. Sami Direct I Confidential I www.samidirect.com 24 Mirtoselect® in supporting healthy visual function In a multicentric study, daily use of Mirtoselect® over a period of one year on 88 patients was associated with remarkable improvement of contrast sensitivity and stabilization of visual acuity leading to improved visual quality. A B Comparison of image with different contrast sensitivity. A: image with low contrast sensitivity; B: image with high contrast sensitivity. Kim E.S. Clinical evaluation of patients with nonproliferative diabetic retinopathy following medication of anthocyanoside: multicenter study. J. Korean Ophthal. Soc. 2008 49 (10),1629-1633. Sami Direct I Confidential I www.samidirect.com 25 Sami Direct I Confidential I www.samidirect.com 26 Zinc Monomethionine • Zinc is organically bound to sulfur containing essential amino acid Methionine. • It has been reported that Zinc monomethionine is absorbed better, retained longer and is more effective than other zinc supplements. • Zinc, a trace element that influences cell metabolism through a variety of mechanisms, appears to play an integral role in maintaining normal ocular function. Sami Direct I Confidential I www.samidirect.com 27 Zinc Monomethionine • Zinc is present in high concentrations in ocular tissue, particularly in retina and choroid (vascular layer of the eye). • It is reported that Zinc interacts with taurine and vitamin A, modify photoreceptor plasma membranes, regulate the light-rhodopsin reaction, modulate synaptic transmission and serve as an antioxidant Sami Direct I Confidential I www.samidirect.com 28 The Age-Related Eye Disease Study • An 11-center double-masked clinical trial, enrolled participants in an AMD trial if they had extensive small drusen, intermediate drusen, large drusen, noncentral geographic atrophy, or pigment abnormalities in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye. • Participants were randomly assigned to receive daily oral tablets containing: (1)antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg); (2) zinc, 80 mg, as zinc oxide and copper, 2 mg, as cupric oxide; (3) antioxidants plus zinc; or (4) placebo. Sami Direct I Confidential I www.samidirect.com 29 Results • Participants drusen or pigment abnormalities had only a 1.3% 5-year probability of progression to advanced AMD on using Zinc supplement. • Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in the higherrisk group. AREDS Report No. 8. Arch Ophthalmol. 2001 October ; 119(10): 1417–1436. Sami Direct I Confidential I www.samidirect.com 30 Sami Direct I Confidential I www.samidirect.com 31 Saffron • • • • Botanical name: Crocus sativus Linn Family: Iridaceae Part used: Stigmas Distribution: Native to Iran and Greece Cultivated largely in Southern Europe, Tibet and other countries. In India, it is mainly cultivated in Kashmir and Uttranchal. Sami Direct I Confidential I www.samidirect.com 32 Chemical constituents Commercially used stigma of saffron contains: • Crocetin • Crocin • • • • • • • • • α and β carotene Lycopene Zeaxanthin Mangicrocin Picocrocin Safranal Anthocyanins Flavanoids Vitamins & essential oils Sami Direct I Confidential I www.samidirect.com Vijayabhargava K. 2011. Int J Pharm Pharm Sci, 3 (3): 22-26 33 Antioxidant effect • Crocin is a pharmacologically active component of saffron. • Treating the PC-12 cells with 10 microM crocin inhibits the formation of peroxidized lipids, restores the SOD activity, and maintains the neuron's morphology. Ochiai T et al. Neurosci Lett. 2004. 13;362(1):61-4. Sami Direct I Confidential I www.samidirect.com 34 Prevention of rod and cone death • Effect of crocin on blue light– and white light– induced rod and cone death in primary retinal cell cultures was investigated. • Cultures were treated by the addition of different concentrations of crocin for 24 hours before light exposure or for 8 hours after light exposure. Laabich et al., IOVS, 2006, 47 (7): 3156 - 3163 Sami Direct I Confidential I www.samidirect.com 35 Control Blue light exposed Pretreated with 80µM crocin Crocin protected the photoreceptors against blue light– or white light–mediated damage in a concentration-dependent manner with an EC50 of approximately 30 µM. This is reported to be due to its antioxidant and neuroprotective activity. Laabich et al., IOVS, 2006, 47 (7): 3156 - 3163 Sami Direct I Confidential I www.samidirect.com 36 Maintain eye morphology Experimental Sprague Dawley rats were prefed either saffron or β-carotene before they were exposed to bright continuous light (BCL) for 24 hours. Maccarone et al., IOVS, 2008, Vol. 49 (3): 1254–1261 Sami Direct I Confidential I www.samidirect.com 37 BCL treated Saffron treated Β-carotene treated Saffron protect photoreceptors from retinal stress, maintains both morphology and function and probably acts as a regulator of programmed cell death Maccarone et al., IOVS, 2008, Vol. 49 (3): 1254–1261 Sami Direct I Confidential I www.samidirect.com 38 Ocular blood flow • The etiology of ischemic retinopathy and agerelated macular degeneration is due in part to the reduction of blood flow in the retina and/or choroid. • Crocin analogs isolated from saffron significantly increase the blood flow in the retina and choroid and to facilitate retinal function recovery. • Increased blood flow due to vasodilation improves oxygenation and nutrient supply of retinal structures. Xuan B et al., J Ocul Pharmacol Ther. 1999;15(2):143-52. Sami Direct I Confidential I www.samidirect.com 39 Retinal flicker sensitivity Clinical study Twenty-five patients with AMD were given oral saffron or placebo over a 3-month period and then reverted to placebo or saffron for a further 3 months. Falsini et al., IOVS, 2010, 51 (12): 6118-6124 Sami Direct I Confidential I www.samidirect.com 40 • Focal electroretinogram (fERG) were increased in amplitude, compared with either baseline or after placebo supplementation. • Short-term saffron supplementation improves retinal flicker sensitivity in early AMD. Falsini et al., IOVS, 2010, 51 (12): 6118-6124 Sami Direct I Confidential I www.samidirect.com 41 Thus the combinatorially additive combination of nutrients of MACUMAX™ is as follows 1. 2. 3. 4. Ingredients ZeaLutein® Mirtoselect® Zinc Monomethionine Saffron extract Sami Direct I Confidential I www.samidirect.com 42 Dosage: 1-2 Capsules per day Age: 12 years and above Contraindications: None Sami Direct I Confidential I www.samidirect.com 43 43 www.sabinsa.com participating members of: THANK YOU Sami Direct I Confidential I www.samidirect.com 44