{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T19:16:12Z","timestamp":1782414972675,"version":"3.54.5"},"reference-count":19,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T00:00:00Z","timestamp":1754006400000},"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":[[2025,8,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>To characterize the safety profile of cenegermin through an analysis of postmarket adverse events (AEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The U.S. Food and Drug Administration adverse event reporting system was queried for AEs associated with cenegermin use between 2019 and 2023. Demographic information was collected. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to determine adverse reactions that were significantly more likely to be caused by cenegermin use compared with other ophthalmical topicals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Most AEs occurred in females (65.16%). The most common AEs were eye pain (46.94%), irritation (14.46%), and ocular hyperemia (9.8%). Of 34 eye disorders that were found to be associated with cenegermin use, the ones with the highest odds ratios were periorbital pain [ROR: 25.34, confidence interval (CI): 20.70\u201331.01, PRR: 16.45], eyelid pain (ROR: 22.96, CI: 19.39\u201327.19, PRR: 15.50), and eye pain (ROR: 20.02, CI: 18.77\u201321.35, PRR: 16.08). Patients taking cenegermin were significantly more likely to develop eye disorders (ROR: 2.21, CI: 2.12\u20132.31, PRR: 1.46), but were not more likely to develop disorders of other system organ classes. In terms of patient outcomes, patients taking cenegermin were at higher risk for hospitalization (ROR: 16.39, CI: 12.84\u201320.94, PRR: 12.17) and surgery (ROR: 9.57, CI: 6.14\u201314.93, PRR: 8.01).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Postmarket surveillance of cenegermin demonstrates that eye pain and irritation are the most common AEs. Involvement of other organ systems is highly unlikely. Patients using topical cengermin should be counseled accordingly.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2025.0023","type":"journal-article","created":{"date-parts":[[2025,5,7]],"date-time":"2025-05-07T05:02:02Z","timestamp":1746594122000},"page":"339-346","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Real-World Safety Profile of Cenegermin Per FDA Adverse Event Reporting System"],"prefix":"10.1177","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4321-7536","authenticated-orcid":false,"given":"Hassaam S.","family":"Choudhry","sequence":"first","affiliation":[{"name":"Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingzhuo","family":"Pei","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0583-4058","authenticated-orcid":false,"given":"David","family":"Mothy","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Scarfuto","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahzad I.","family":"Mian","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, University of Michigan Medical School, Ann Arbor, Michigan, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,8,11]]},"reference":[{"key":"e_1_3_5_2_2","volume-title":"StatPearls","author":"Adams BS","year":"2023","unstructured":"Adams BS, , Patel AR. Cenegermin. In: StatPearls. StatPearls Publishing: Treasure Island, FL; 2023."},{"issue":"11","key":"e_1_3_5_3_2","first-page":"659","article-title":"Pharmaceutical approval update","volume":"43","author":"Kaufman MB","year":"2018","unstructured":"Kaufman MB. Pharmaceutical approval update. P T, 2018; 43(11):659\u2013661.","journal-title":"P T"},{"key":"e_1_3_5_4_2","volume-title":"StatPearls","author":"Feroze KB","year":"2023","unstructured":"Feroze KB, , Patel BC. Neurotrophic Keratitis. In: StatPearls. 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Available from: https:\/\/open.fda.gov\/data\/faers\/"},{"key":"e_1_3_5_14_2","unstructured":"Introductory Guide MedDRA Version 21.0; 2018. Available from: https:\/\/admin.meddra.org\/sites\/default\/files\/guidance\/file\/intguide_21_0_english.pdf [Last accessed: February23 2024]."},{"key":"e_1_3_5_15_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200023060-00004"},{"key":"e_1_3_5_16_2","volume-title":"Drugs and Lactation Database (LactMed\u00ae)","year":"2018","unstructured":"Cenegermin. In: Drugs and Lactation Database (LactMed\u00ae). National Institute of Child Health and Human Development: Bethesda, MD; 2018."},{"key":"e_1_3_5_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajoc.2022.101488"},{"key":"e_1_3_5_18_2","doi-asserted-by":"publisher","DOI":"10.2147\/EB.S117261"},{"key":"e_1_3_5_19_2","doi-asserted-by":"publisher","DOI":"10.1055\/a-1274-3675"},{"key":"e_1_3_5_20_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-022-23726-4"}],"container-title":["Journal of Ocular Pharmacology and Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jop.2025.0023","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jop.2025.0023","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jop.2025.0023","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T14:47:05Z","timestamp":1777646825000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jop.2025.0023"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,1]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,8,1]]}},"alternative-id":["10.1089\/jop.2025.0023"],"URL":"https:\/\/doi.org\/10.1089\/jop.2025.0023","relation":{},"ISSN":["1080-7683","1557-7732"],"issn-type":[{"value":"1080-7683","type":"print"},{"value":"1557-7732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,1]]}}}