{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T15:54:02Z","timestamp":1777910042558,"version":"3.51.4"},"reference-count":29,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"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":[[2025,1,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>Pharmacokinetic evaluation of ocular penetration and systemic accumulation of preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      In a preclinical study, pigmented rabbits received a single ocular administration of PFB 0.01% gel (\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      = 15) or preserved bimatoprost 0.01% or 0.03% ophthalmic solution [PB 0.01% (\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      = 15) or PB 0.03% (\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      = 15)]. The aqueous humor, iris, and ciliary body were analyzed for bimatoprost+bimatoprost free acid. In a Phase 1, randomized, open-label clinical study, healthy participants received PFB 0.01% gel (\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      = 20) or PB 0.01% (\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      = 20) daily in each eye (Days 1\u201315). Bimatoprost levels in human plasma were analyzed on Days 1 and 15. All serological analyses used validated methods. Adverse events were collected throughout and ocular assessments were performed on Days 1 and 15.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      In the preclinical study, Cmax (bimatoprost+bimatoprost free acid) for PFB 0.01% gel, PB 0.01%, and PB 0.03% was 50.2, 26.3, and 59.9 ng\/mL; AUC\n                      <jats:sub>0.5\u20138\u2009h<\/jats:sub>\n                      was 134.0 ng\u00b7h\/mL, 67.0 ng\u00b7h\/mL, and 148.0 ng\u00b7h\/mL. In the clinical study, systemic exposure to bimatoprost (AUC\n                      <jats:sub>0\u2013last<\/jats:sub>\n                      ) on Days 1 and 15 was lower for PFB 0.01% gel (0.5248 and 0.5645 ng\u00b7min\/mL) than PB 0.01% (0.8461 and 0.7551 ng\u00b7min\/mL), with no systemic accumulation of bimatoprost in either group. There were no clinically important differences between groups in ocular or systemic tolerability in the clinical study and no serious adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>PFB 0.01% gel showed improved ocular penetration compared with PB 0.01%. Systemic absorption was comparable, with a favorable clinical safety profile, supporting PFB 0.01% gel as a potential treatment for glaucoma and ocular hypertension.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2024.0092","type":"journal-article","created":{"date-parts":[[2024,11,7]],"date-time":"2024-11-07T12:09:19Z","timestamp":1730981359000},"page":"8-16","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Preclinical and Clinical Pharmacokinetics of a New Preservative-Free Bimatoprost 0.01% Ophthalmic Gel to Treat Glaucoma and Ocular Hypertension"],"prefix":"10.1177","volume":"41","author":[{"given":"Carl","family":"Erb","sequence":"first","affiliation":[{"name":"Eye Clinic Wittenbergplatz, Berlin, Germany."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fotis","family":"Topouzis","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, School of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hari","family":"Jayaram","sequence":"additional","affiliation":[{"name":"Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom."},{"name":"NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, United Kingdom."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fanny","family":"Allan","sequence":"additional","affiliation":[{"name":"Laboratoires Th\u00e9a, Clermont-Ferrand, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sylvie","family":"Nissl\u00e9","sequence":"additional","affiliation":[{"name":"Laboratoires Th\u00e9a, Clermont-Ferrand, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco J.","family":"Mu\u00f1oz-Negrete","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Hospital Universitario Ram\u00f3n y Cajal, Madrid, Spain."},{"name":"Facultad de Medicina, Universidad de Alcal\u00e1, IRYCIS, Madrid, Spain."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingeborg","family":"Stalmans","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, University Hospitals UZ Leuven, Leuven, Belgium."},{"name":"Research Group of Ophthalmology, Catholic University KU Leuven, Leuven, Belgium."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,1,31]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.survophthal.2008.08.012"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1155\/2018\/1319628"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2009.12.003"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2006.094326"},{"key":"e_1_3_6_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.120.10.1286"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2007.128454"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S137537"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S59197"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41433-021-01668-x"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0b013e31825af67d"},{"key":"e_1_3_6_12_2","doi-asserted-by":"publisher","DOI":"10.1177\/112067210701700311"},{"key":"e_1_3_6_13_2","doi-asserted-by":"publisher","DOI":"10.1111\/aos.14410"},{"key":"e_1_3_6_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.preteyeres.2010.03.001"},{"key":"e_1_3_6_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0000000000002371"},{"key":"e_1_3_6_16_2","unstructured":"Association for Research in Vision and Ophthalmology. 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