Ambati J, Ambati BK, Yoo SH, Ianchulev S, Adamis AP. Age-related macular degeneration: etiology, pathogenesis, and therapeutic strategies. Surv Ophthalmol. 2003;48:257–93.

Article  PubMed  Google Scholar 

Ferris FLI, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984;102:1640–2.

Article  PubMed  Google Scholar 

Solomon SD, Lindsley KB, Vedula SS, Krzystlik MG, Hawkins BS. Anti-vascular endothelial growth factor for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2019;3(Mar):CD005139.

PubMed  Google Scholar 

Rosenberg D, Deonarain DM, Gould J, Sothivannan A, Philips MR, Sarohia GS, et al. Efficacy, safety, and treatment burden of treat-and-extend versus alternative anti-VEGF regimens for nAMD: a systematic review and meta-analysis. Eye (Lond). 2022;37:6–16.

Article  PubMed  Google Scholar 

Bressler NM, Kaiser PK, Do DV, Nguyen QD, Park KH, Woo SJ, et al. Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review. (1879-3304 (Electronic)).

Batran RA-O, Elmoshneb M, Hussein AA-O, Hussien OM, Adel F, Elgarhy R, et al. Biosimilars: science, implications, and potential outlooks in the Middle East and Africa. (1177-5475 (Print)).

European Medicines Agency. Biosimilar medicines: marketing authorisation. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/biosimilar-medicines-marketing-authorisation.

U.S. Food & Drug Administration. Review and Approval. Available at: https://www.fda.gov/drugs/biosimilars/review-and-approval.

US Food and Drug Administration. Questions and answers on biosimilar development and the BPCI Act guidance for industry. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act-guidance-industry.

Ministry of Health, Labour and Welfare. Guidelines for the quality, safety and efficacy assurance of follow‐on biologics. Available at: www.pmda.go.jp/files/000153851.pdf.

European Medicines Agency. Guideline on similar biological medicinal products. Available at: www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-first-version_en.pdf.

Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020;5:CD012208.

PubMed  Google Scholar 

Sunaga T, Maeda M, Saulle R, Ng SM, Sato MT, Hasegawa T, et al. Anti-vascular endothelial growth factor biosimilars for macular degeneration. Cochrane Database Syst Rev. 2024;6:CD015804.

PubMed  Google Scholar 

Klein R, Klein BE, Linton KL. The beaver dam eye study. Ophthalmol. 1992;99:933–43.

Article  CAS  Google Scholar 

Okada M, Mitchell P, Finger RP, Eldem B, Talks SJ, Hirst C, et al. Nonadherence or nonpersistence to intravitreal injection therapy for neovascular age-related macular degeneration:: a mixed-methods systematic review. Ophthalmol. 2021;128:234–47.

Article  Google Scholar 

Mehta H, Kim LN, Mathis T, Zalmay P, Ghanchi F, Amoaku WM, et al. Trends in real-world neovascular amd treatment outcomes in the UK. Clin Epidemiol. 2020;14:3331–42.

Google Scholar 

Hernán MA, Wang W, Leaf DE. Target trial emulation: a framework for causal inference from observational data. JAMA. 2022;328:2446–7.

Article  PubMed  Google Scholar 

Franklin JM, Patorno E, Desai RJ, Glynn RJ, Martin D, Quinto K, et al. Emulating randomized clinical trials with nonrandomized real-world evidence studies. Circulation. 2021;143:1002–13.

Article  PubMed  Google Scholar 

Gallivan MD, Garcia KM, Torres AZ, Lum F, Li C, Mbagwu M, et al. Emulating VIEW 1 and VIEW 2 clinical trial outcome data using the American Academy of ophthalmology IRIS registry. Ophthalmic Surg Lasers Imaging Retin. 2023;54:6–14.

Article  Google Scholar 

Thomas DS, Lee AY, Müller PL, Schwartz R, Olvera-Barrios A, Warwick AN, et al. Contextualizing single-arm trials with real-world data: An emulated target trial comparing therapies for neovascular age-related macular degeneration. Clin Transl Sci. 2021;14:1166–75.

Article  CAS  PubMed  PubMed Central  Google Scholar