Abstract
This chapter strives to provide an understanding of the overall drug product approval process and highlights the key points that a sponsor needs to focus on in order to successfully develop and market a posterior ocular segment drug. Furthermore, the chapter reviews the product summary basis of approvals for two recently approved and marketed products namely Ozurdex™, a dexamethasone containing intraocular drug delivery system for the treatment of macular edema following branch or central retinal vein occlusion (BRVO or CRVO) and Lucentis™, a recombinant, humanized monoclonal IgG1 antibody antigen-binding fragment (Fab) indicated for neovascular (wet) age-related macular degeneration (ARMD). The importance of scientific dialogue between the sponsor and the corresponding health agency is emphasized and encouraged.
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References
Clark AF, Yorio T (2003) Ophthalmic drug discovery. Nat Rev Drug Discov 2(6):448–459
Draft FDA Guidance for Industry: Adaptive design clinical trials for drugs and biologics. Feb 2010 (http://www.fda.gov/downloads/Drugs/guidancecomplianceregulatoryinformation/guidances/ucm201790.pdf)
Draft FDA Guidance for Industry: Applications covered by Section 505(b)(2). Oct 1999 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf)
Drug Approval Package: LUCENTIS™ (Ranibizumab) Injection. Approval Date – 06/30/2006
Drug Approval Package: OZURDEX™ (Dexamethasone Intravitreal Implant). Approval Date – 06/17/2009
Drugs @ FDA available on the FDA Website at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Edelman JL, Lutz D, Castro MR (2005) Corticosteroids inhibit VEGF-induced vascular leakage in a rabbit model of blood-retinal and blood-aqueous barrier breakdown. Exp Eye Res 80(2):249–258
FDA Guidance for Industry, Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products, November 1995 (http://www.fda.gov/downloads/Drugs/Guidance-ComplianceRegulatoryInformation/Guidances/ucm071597.pdf)
FDA Guidance for Industry: Formal Meetings with Sponsors and Applicants for PDUFA Products. Feb 2000 (http://www.fda.gov/cder/guidance/index.htm).
Ghodes DM, Balamurugan A, Larsen BA, Maylahn C (2005) Age-related eye diseases: an emerging challenge for public health professionals. Prev Chronic Dis 2(3):A17
Gordon DM (1959a) Dexamethasone in ophthalmology. Am J Ophthalmol 48:656–660
Gordon DM (1959b) Dexamethasone in ophthalmic disorders. Ann N Y Acad Sci 82:1008–1011
Gryziewicz JL, Whitcup SM (2006) Regulatory issues in drug delivery to the eye. In: Intraocular drug delivery, 1st edn
Gryziewicz L (2005) Regulatory aspects of drug approval for macular degeneration. Adv Drug Deliv Rev 57(14):2092–2098
Lee SS, Robinson MR (2009) Novel drug delivery systems for retinal diseases: a review. Opthalmic Res 41(3):124–135
Marra M, Gukasyan HJ, Raghava S, Kompella UB (2007) 2nd Ophthalmic drug development and delivery summit. Expert Opin Drug Deliv 4(1):77–85
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© 2011 American Association of Pharmaceutical Scientists
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Kulkarni, A.A. (2011). Regulatory Considerations in Product Development for Back of the Eye. In: Kompella, U., Edelhauser, H. (eds) Drug Product Development for the Back of the Eye. AAPS Advances in the Pharmaceutical Sciences Series, vol 2. Springer, Boston, MA. https://doi.org/10.1007/978-1-4419-9920-7_19
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DOI: https://doi.org/10.1007/978-1-4419-9920-7_19
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