{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T15:53:36Z","timestamp":1777910016472,"version":"3.51.4"},"reference-count":43,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T00:00:00Z","timestamp":1696118400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Ocular Pharmacology and Therapeutics"],"published-print":{"date-parts":[[2023,10,1]]},"abstract":"<jats:p>\n                    The dynamic and continuously evolving field of ophthalmology necessitates rigorous regulatory oversight in the United States. This review outlines the multifaceted Food and Drug Administration's (FDA) approval process for ophthalmic products, detailing the classifications, pathways, and regulatory compliance for devices, drugs, biologics, and combination products. Particular emphasis is placed on distinct frameworks for Class I, II, and III devices, as well as regulations for drugs, biologics, and combination products. The organizational structure of the FDA is detailed, with highlights on specific Ophthalmology oversight divisions, historical regulatory evolution, and initiatives such as Patient-Focused Drug Development. An in-depth examination of the regulatory journey, ranging from initial research to post-marketing surveillance, includes practical guidance through stages such as Pre-Investigational New Drug\/Pre-Submission consultations, clinical trials, new drug application\/biologics license application\/premarket approval submissions, and FDA advisory committee interactions. The article underscores the importance of early interactions with the health authorities, interdisciplinary team collaboration, adherence to current standards, and the anticipation of policy changes to ensure patient safety. It concludes with an analysis of 4 key FDA-approved ophthalmic products, including Eylea\n                    <jats:sup>\u00ae<\/jats:sup>\n                    , Luxturna\n                    <jats:sup>\u00ae<\/jats:sup>\n                    , Alphagan P\n                    <jats:sup>\u00ae<\/jats:sup>\n                    , and the Raindrop\n                    <jats:sup>\u00ae<\/jats:sup>\n                    Near Vision Inlay, detailing their contributions to ophthalmic care and offering valuable insights into their respective clinical trials, regulatory pathways, and potential implications. These case studies are included to illustrate both successful and failed ophthalmic product launches, thereby highlighting the importance of alignment with regulatory compliance.\n                  <\/jats:p>","DOI":"10.1089\/jop.2023.0071","type":"journal-article","created":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T15:12:06Z","timestamp":1696518726000},"page":"572-582","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Eyes on the Prize: Decoding the Ophthalmic Product Regulations and Intricacies of the U.S. Food and Drug Administration Approval"],"prefix":"10.1177","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2463-1742","authenticated-orcid":false,"given":"Khemraj","family":"Hirani","sequence":"first","affiliation":[{"name":"Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mylarrao","family":"Bansinath","sequence":"additional","affiliation":[{"name":"Independent Product Development Consultant, North Brunswick, New Jersey, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rahul","family":"Mittal","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joana R.N.","family":"Lemos","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Adis","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Priyanka","family":"Poojari","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane Margaret","family":"Igoe","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcio R.","family":"Soares","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3759-647X","authenticated-orcid":false,"given":"Sanjoy","family":"Bhattacharya","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roy E.","family":"Weiss","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2023,10,17]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"U.S. Food and Drug Administration: FDA 101: An Overview of FDA's Regulatory Review and Research Activities. 2022. 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