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Acta Ophthalmol. 2010 Mar;88(2):163-73. Epub 2009 Dec 17. Assessment of functional vision and its rehabilitation. Colenbrander A Reproduced courtesy of the author

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2 4 6 8 10 12 14 16 N 1996 1998 2001 2003 2005 2008 2010 Year

CHMP SA Ophth Procedures by Year

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Breakdown of SA procedures by Anatomical Therapeutic area

AS 38% IOP 22% PS 31% Uveitis 9%

. +D D 33 6 75 100 20 40 60 80 100 AS IOP PS Uveitis

SA Questions on Functional Endpoints by Anatomical Therapeutic area

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Wet AMD 2006 Ranibizumab LUCENTIS Vitreous Haemorrhage 2007 Ovine hyaluronidase VITRAGAN IOP 2006 Bimatroprost/timolol GANFORT IOP 2006 Travoprost/timolol maleate DUOTRAV Wet AMD 2006 Anecortave acetate RETAANE Wet AMD 2005 Pegaptanib sodium MACUGEN Allergic conjunctivitis 2002 Olopatadine OPATANOL Anterior segment x INN2 PRODUCT Y IOP 2001 Travoprost TRAVATAN IOP 2001 Bimatoprost LUMIGAN Sicca Syndrome. 2001 Cevimeline hydrochloride EVOXAC Wet AMD 2000 Verteporfin VISUDYNE CMV retinitis 1999 Fomivirsen VITRAVENE IOP 1999 Brinzolamide AZOPT Anterior segment x INN1 PRODUCT X Allergic conjunctivitis 1998 Emedastine EMADINE CMV retinitis 1996 Ganciclovir VITRASERT CMV retinitis 1996 Cidofovir VISTIDE Therapeutic area MAA Year INNCommonName PRODUCTNAME

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IOP 2010 Latanoprost XALATAN ANTERIOR SEGMENT x 0))* PRODUCT C LEBER'S OPTIC NEUROPATHY Ongoing SAN IDEBENONE WET AMD Ongoing VEGF-TRAP EYLEA UVEITIS 2010 Voclosporin LUVENIQ VEIN OCCLUSION MACULAR OEDEMA 2010 Dexamethasone OZURDEX VERNAL KERATOCONJUNCTIVITIS 2008 Ciclosporine VEKACIA POST CATARACT PAIN AND INFLAMMATION 2011 Bromfenac YELLOX POST CATARACT PAIN AND INFLAMMATION 2007 Nepafenac NEVANAC IOP 2008 Brinzolamide / timolol AZARGA UVEITIS 2007 Flucinolone acetonide RETISERT DIABETIC RETINOPATHY 2007 Ruboxistaurin ARXXANT

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Year of MAA validation

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30% 23% 40% 7% AS IOP PS Uveitis

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