{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T21:54:47Z","timestamp":1781560487122,"version":"3.54.5"},"reference-count":53,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T00:00:00Z","timestamp":1692057600000},"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":[[2023,11,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>The systemic and ocular pharmacokinetics (PK), and ocular toxicity of benzalkonium chloride (BAK)-free TearClear latanoprost ophthalmic solution, 0.005% formulation (TC-002) were evaluated. TC-002 is designed to selectively capture BAK at the time of drug administration; therefore, the dose delivered to the eye contains no quantifiable level of preservative.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      The systemic and ocular PK of TC-002 were compared to a BAK containing reference listed drug (RLD, Xalatan\u2122) over a 24-h period, after a single topical ocular dose to 1 eye of male Dutch Belted (DB) rabbits (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20093\/timepoint). Latanoprost acid concentrations were measured in plasma and ocular tissues. The ocular toxicity was evaluated in a separate study and included toxicokinetic evaluation of TC-002 after once daily topical ocular dosing into each eye of DB rabbits (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u20098\/group) for at least 28 days. Toxicity endpoints included ophthalmic and clinical evaluations, necropsy, and microscopic evaluation of ocular tissues.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Average ratios of\n                      <jats:italic toggle=\"yes\">C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      values for TC-002\/RLD ranged from 0.6 to 1.6, and\n                      <jats:italic toggle=\"yes\">C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      and area under the concentration-time curve of last observed concentration (AUC\n                      <jats:sub>last<\/jats:sub>\n                      ) exposures to latanoprost acid were similar (&lt;2-fold) between the 2 treatments. In the 28-day study, the\n                      <jats:italic toggle=\"yes\">T<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      was achieved in both groups in &lt;0.5\u2009h. There were no abnormal ocular findings.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>TC-002 with no quantifiable preservative or BAK-containing RLD exhibited similar ocular and systemic PK profiles. TC-002 was well tolerated and comparable to RLD. TC-002 retains the safety and PK characteristics of RLD without the added concern of long-term exposure of the eye to preservatives.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2023.0050","type":"journal-article","created":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T17:00:54Z","timestamp":1692118854000},"page":"622-630","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetic and Ocular Toxicity Evaluation of Latanoprost Ophthalmic Solution, 0.005%, with Preservative Level Reduced to Below the Limit of Quantitation"],"prefix":"10.1177","volume":"39","author":[{"given":"Srini","family":"Venkatesh","sequence":"first","affiliation":[{"name":"TearClear, Princeton, NJ, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Richardson","sequence":"additional","affiliation":[{"name":"Iuvo Bioscience, Rush, New York, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,8,15]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2022.07.007"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.joco.2018.07.003"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.preteyeres.2010.03.001"},{"key":"e_1_3_5_5_2","first-page":"1575","article-title":"Challenges in the clinical measurement of ocular surface disease in glaucoma patients","volume":"5","author":"Pflugfelder SC","year":"2011","unstructured":"Pflugfelder SC, , Baudouin C. 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