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Expert Opinion on Emerging Drugs Volume 8, 2003 - Issue 1
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Review

Emerging drugs for ophthalmic diseases

Gary D Novack PharmaLogic Development, Inc., 17 Bridgegate Drive, San Rafael, CA 94903-1093, USA
Pages 251-266 | Published online: 02 Mar 2005

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  • •Summary of the safety profile of new glaucoma medications, especially in the elderly.
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  • •Initial report of the efficacy of an intravitreal delivery system in a controlled study; in this case, ganciclovir for CMV retinitis.
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  • ••Classic article quantifying corticosteroid-induced glaucoma.
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  • •Key article on the concept of 'soft drug' development.
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  • ••Key report of one of the first National EyeInstitute-sponsored, multi-centred trials, and a major impact on ophthalmology.
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  • •Very large, controlled, prospective study of the impact of antioxidants on macular degeneration.
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  • NOVACK GD: Financing new drug development in ophthalmology. Glaucoma (2000) 9:195–199.
  • LICHTER PR, MUSCH DC, GILLESPIE BW et al.: Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery. Ophthalmology (2001) 108:1943–1953.
  • •Large controlled study of surgery versus medicine for initial therapy of glaucoma.
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  • •Large controlled study of medicine versus no treatment for therapy of ocular hypertension.
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  • STEVENSON D, TAUBER J, REIS BL: Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate to severe dry eye disease: a dose-ranging, randomized trial. Ophthalmology (2000) 107:967–974.
  • SALL K, STEVENSON OD, MUNDORF TK, REIS BL: Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase III Study Group. Ophthalmology (2000) 107(4):631–639.
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  • MUNDASAD MV, NOVACK GD, ALLGOOD VE, EVANS RM, GORDEN JC, YERXA BR: Ocular safety of IN5365 ophthalmic solution: a P2Y2 agonist, in healthy subjects. .1 Ocul Pharmacol Ther. (2001) 17(2):173–179.
  • YERXA BR, MUNDASAD M, SYLVESTER RN, GORDEN JC, COOPER M, KELLERMAN DJ: A Double-masked, randomized, placebo-controlled, rising-dose study of multiple ocular instillations of IN5365 ophthalmic solution in patients with mild to moderate dry eye disease. In: Lacrimal Gland, Tear Film and Dry Eye Syndromes 3: Advances M Experimental Medicine and Biology Sullivan DA, Stern ME, Tsubota K, Dartt DA, Sullivan RM, Bromberg BB (Eds), Kluwer Academic/Plenum Press, New York, NY (2002):1251–1257.
  • FOULKS GN: Challenges and pitfalls in clinical trials of treatments for dry eye. The Ocular Surface (2003) 1(1):20–30.
  • ••Complete overview of the issues inconducting clinical trials in dry eye therapy.
  • NOVACK GD: Pharmacological treatments for dry eye: a worthwhile investment! Cornea (2002) 21:4–5.
  • POGUE BW, REDMOND RW, TRIVEDI N, HASAN T: Photophysical properties of tin ethyl etiopurpurin I (SnET2) and tin octaethylbenzochlorin (SnOEBC) in solution and bound to albumin. Photochem. Photobiol (1998) 68(6):809–815.
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  • THE EYETECH STUDY GROUP: Preclinical and Phase IA clinical evaluation of an anti-VEGF pegylated aptamer (EYE001) for the treatment of exudative age-related macular degeneration. Retina (2002) 22(2):143–152.
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  • NO AUTHORS LISTED: Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD): interim (Month 6) analysis of clinical efficacy and safety. The Anecortave Acetate Clinical Study Group. Retina (2003).
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  • JAFFE GJ, BEN-NUN J, GUO H, DUNN JP, ASHTON P: Fluocinolone acetonide sustained drug delivery device to treat severe uveitis. Ophthalmology (2000) 107:2024–2033.
  • MAMINISHKIS A, JALICKEE S, BLAUG SA et al.: The P2Y(2) receptor agonist IN537217 stimulates RPE fluid transport M vitro and retinal reattachment in rat. Invest. Ophthalmol Vis. Sci. (2002) 43(11):3555–3566.
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  • NOVACK GD, EVANS R: Commercially available ocular hypotensive products: preservative concentration, stability, storage, and in-life utilization. J. Glaucoma (2001) 10(6) :483–486.

Websites

  • http://cms.hhs.gov/statistics/feeforservice/ ProcCodes00.pdf Medicare leading part B procedure codes based on allowed charges calendar year 2000, Dec 11 2002.
  • http://www.doh.gov.uk/nhsexec/ refcosts.htm Reference costs 2002, Jan 3 2003.
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