24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients
Objective The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG). Methods...
Gespeichert in:
| Veröffentlicht in: | Drugs (New York, N.Y.) N.Y.), 2020-02, Vol.80 (2), p.167-179 |
|---|---|
| Hauptverfasser: | , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 179 |
|---|---|
| container_issue | 2 |
| container_start_page | 167 |
| container_title | Drugs (New York, N.Y.) |
| container_volume | 80 |
| creator | Craven, E. Randy Walters, Thomas Christie, William C. Day, Douglas G. Lewis, Richard A. Goodkin, Margot L. Chen, Michelle Wangsadipura, Veronica Robinson, Michael R. Bejanian, Marina |
| description | Objective
The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
Methods
This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (
N
= 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
Results
At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
Conclusions
Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364 |
| doi_str_mv | 10.1007/s40265-019-01248-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7007425</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2356726994</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-37372ec2e906ea1246a4ad2182070958c3c08a6a3162b6a017177ea384d1c3ae3</originalsourceid><addsrcrecordid>eNp9UUtPXCEUJqZNndr-ARcNSTd2QeV14bJpopPWTqLRWLsmR4ZxMHdgBrgm_fdFx1rduAAC53ucw4fQPqNfGaX6sEjKVUcoM21x2RO6gyaMaUOY6egbNKHtmSil9C56X8rt_dV05h3aFazvZafkBG24JGcp1iW-WELxeHY4m-HpEGJwMOCrHNqeFvg4rKCmdU6l4l9jqRCin5NLP_gH0mo9QKz44AXs8gsOEZ8MMLq0AnwBNfhYywf0dgFD8R8fzz30-8f3q-lPcnp-MpsenRIntaxEaKG5d9wbqjy08RRImHPWc6qp6XonHO1BgWCKXyugTDOtPYhezpkT4MUe-rbVXY_XKz93zTvDYNe59Zj_2ATBvqzEsLQ36c7q9reSd03g86NATpvRl2pv05hj69ly0SnNlTGyofgW5drUJfvFkwOj9j4mu43JtpjsQ0yWNtKn5709Uf7l0gBiCyitFG98_u_9iuxfPYadEA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2356726994</pqid></control><display><type>article</type><title>24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Craven, E. Randy ; Walters, Thomas ; Christie, William C. ; Day, Douglas G. ; Lewis, Richard A. ; Goodkin, Margot L. ; Chen, Michelle ; Wangsadipura, Veronica ; Robinson, Michael R. ; Bejanian, Marina</creator><creatorcontrib>Craven, E. Randy ; Walters, Thomas ; Christie, William C. ; Day, Douglas G. ; Lewis, Richard A. ; Goodkin, Margot L. ; Chen, Michelle ; Wangsadipura, Veronica ; Robinson, Michael R. ; Bejanian, Marina ; Bimatoprost SR Study Group ; for the Bimatoprost SR Study Group</creatorcontrib><description>Objective
The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
Methods
This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (
N
= 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
Results
At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
Conclusions
Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364</description><identifier>ISSN: 0012-6667</identifier><identifier>EISSN: 1179-1950</identifier><identifier>DOI: 10.1007/s40265-019-01248-0</identifier><identifier>PMID: 31884564</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Absorbable Implants ; Aged ; Antihypertensive Agents - administration & dosage ; Antihypertensive Agents - adverse effects ; Antihypertensive Agents - therapeutic use ; Bimatoprost - administration & dosage ; Bimatoprost - adverse effects ; Bimatoprost - therapeutic use ; Biodegradability ; Biodegradation ; Clinical trials ; Controlled release ; Dose-Response Relationship, Drug ; Drug dosages ; Evaluation ; Eye ; Female ; Glaucoma ; Glaucoma - diagnosis ; Glaucoma - drug therapy ; Humans ; Hypertension ; Injections, Intraocular ; Internal Medicine ; Internet resources ; Intraocular pressure ; Intraocular Pressure - drug effects ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Original ; Original Research Article ; Patients ; Pharmacology/Toxicology ; Pharmacotherapy ; Pressure effects ; Prospective Studies ; Safety ; Safety measures ; Surgery ; Time Factors ; Transplants & implants ; Treatment Outcome</subject><ispartof>Drugs (New York, N.Y.), 2020-02, Vol.80 (2), p.167-179</ispartof><rights>The Author(s) 2019</rights><rights>Copyright Springer Nature B.V. Feb 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-37372ec2e906ea1246a4ad2182070958c3c08a6a3162b6a017177ea384d1c3ae3</citedby><cites>FETCH-LOGICAL-c474t-37372ec2e906ea1246a4ad2182070958c3c08a6a3162b6a017177ea384d1c3ae3</cites><orcidid>0000-0002-2077-659X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40265-019-01248-0$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40265-019-01248-0$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,315,781,785,886,27926,27927,41490,42559,51321</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31884564$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Craven, E. Randy</creatorcontrib><creatorcontrib>Walters, Thomas</creatorcontrib><creatorcontrib>Christie, William C.</creatorcontrib><creatorcontrib>Day, Douglas G.</creatorcontrib><creatorcontrib>Lewis, Richard A.</creatorcontrib><creatorcontrib>Goodkin, Margot L.</creatorcontrib><creatorcontrib>Chen, Michelle</creatorcontrib><creatorcontrib>Wangsadipura, Veronica</creatorcontrib><creatorcontrib>Robinson, Michael R.</creatorcontrib><creatorcontrib>Bejanian, Marina</creatorcontrib><creatorcontrib>Bimatoprost SR Study Group</creatorcontrib><creatorcontrib>for the Bimatoprost SR Study Group</creatorcontrib><title>24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients</title><title>Drugs (New York, N.Y.)</title><addtitle>Drugs</addtitle><addtitle>Drugs</addtitle><description>Objective
The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
Methods
This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (
N
= 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
Results
At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
Conclusions
Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364</description><subject>Absorbable Implants</subject><subject>Aged</subject><subject>Antihypertensive Agents - administration & dosage</subject><subject>Antihypertensive Agents - adverse effects</subject><subject>Antihypertensive Agents - therapeutic use</subject><subject>Bimatoprost - administration & dosage</subject><subject>Bimatoprost - adverse effects</subject><subject>Bimatoprost - therapeutic use</subject><subject>Biodegradability</subject><subject>Biodegradation</subject><subject>Clinical trials</subject><subject>Controlled release</subject><subject>Dose-Response Relationship, Drug</subject><subject>Drug dosages</subject><subject>Evaluation</subject><subject>Eye</subject><subject>Female</subject><subject>Glaucoma</subject><subject>Glaucoma - diagnosis</subject><subject>Glaucoma - drug therapy</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Injections, Intraocular</subject><subject>Internal Medicine</subject><subject>Internet resources</subject><subject>Intraocular pressure</subject><subject>Intraocular Pressure - drug effects</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Pressure effects</subject><subject>Prospective Studies</subject><subject>Safety</subject><subject>Safety measures</subject><subject>Surgery</subject><subject>Time Factors</subject><subject>Transplants & implants</subject><subject>Treatment Outcome</subject><issn>0012-6667</issn><issn>1179-1950</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9UUtPXCEUJqZNndr-ARcNSTd2QeV14bJpopPWTqLRWLsmR4ZxMHdgBrgm_fdFx1rduAAC53ucw4fQPqNfGaX6sEjKVUcoM21x2RO6gyaMaUOY6egbNKHtmSil9C56X8rt_dV05h3aFazvZafkBG24JGcp1iW-WELxeHY4m-HpEGJwMOCrHNqeFvg4rKCmdU6l4l9jqRCin5NLP_gH0mo9QKz44AXs8gsOEZ8MMLq0AnwBNfhYywf0dgFD8R8fzz30-8f3q-lPcnp-MpsenRIntaxEaKG5d9wbqjy08RRImHPWc6qp6XonHO1BgWCKXyugTDOtPYhezpkT4MUe-rbVXY_XKz93zTvDYNe59Zj_2ATBvqzEsLQ36c7q9reSd03g86NATpvRl2pv05hj69ly0SnNlTGyofgW5drUJfvFkwOj9j4mu43JtpjsQ0yWNtKn5709Uf7l0gBiCyitFG98_u_9iuxfPYadEA</recordid><startdate>20200201</startdate><enddate>20200201</enddate><creator>Craven, E. Randy</creator><creator>Walters, Thomas</creator><creator>Christie, William C.</creator><creator>Day, Douglas G.</creator><creator>Lewis, Richard A.</creator><creator>Goodkin, Margot L.</creator><creator>Chen, Michelle</creator><creator>Wangsadipura, Veronica</creator><creator>Robinson, Michael R.</creator><creator>Bejanian, Marina</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7QO</scope><scope>7RV</scope><scope>7TK</scope><scope>7U7</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-2077-659X</orcidid></search><sort><creationdate>20200201</creationdate><title>24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients</title><author>Craven, E. Randy ; Walters, Thomas ; Christie, William C. ; Day, Douglas G. ; Lewis, Richard A. ; Goodkin, Margot L. ; Chen, Michelle ; Wangsadipura, Veronica ; Robinson, Michael R. ; Bejanian, Marina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-37372ec2e906ea1246a4ad2182070958c3c08a6a3162b6a017177ea384d1c3ae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Absorbable Implants</topic><topic>Aged</topic><topic>Antihypertensive Agents - administration & dosage</topic><topic>Antihypertensive Agents - adverse effects</topic><topic>Antihypertensive Agents - therapeutic use</topic><topic>Bimatoprost - administration & dosage</topic><topic>Bimatoprost - adverse effects</topic><topic>Bimatoprost - therapeutic use</topic><topic>Biodegradability</topic><topic>Biodegradation</topic><topic>Clinical trials</topic><topic>Controlled release</topic><topic>Dose-Response Relationship, Drug</topic><topic>Drug dosages</topic><topic>Evaluation</topic><topic>Eye</topic><topic>Female</topic><topic>Glaucoma</topic><topic>Glaucoma - diagnosis</topic><topic>Glaucoma - drug therapy</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Injections, Intraocular</topic><topic>Internal Medicine</topic><topic>Internet resources</topic><topic>Intraocular pressure</topic><topic>Intraocular Pressure - drug effects</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Patients</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacotherapy</topic><topic>Pressure effects</topic><topic>Prospective Studies</topic><topic>Safety</topic><topic>Safety measures</topic><topic>Surgery</topic><topic>Time Factors</topic><topic>Transplants & implants</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Craven, E. Randy</creatorcontrib><creatorcontrib>Walters, Thomas</creatorcontrib><creatorcontrib>Christie, William C.</creatorcontrib><creatorcontrib>Day, Douglas G.</creatorcontrib><creatorcontrib>Lewis, Richard A.</creatorcontrib><creatorcontrib>Goodkin, Margot L.</creatorcontrib><creatorcontrib>Chen, Michelle</creatorcontrib><creatorcontrib>Wangsadipura, Veronica</creatorcontrib><creatorcontrib>Robinson, Michael R.</creatorcontrib><creatorcontrib>Bejanian, Marina</creatorcontrib><creatorcontrib>Bimatoprost SR Study Group</creatorcontrib><creatorcontrib>for the Bimatoprost SR Study Group</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Drugs (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Craven, E. Randy</au><au>Walters, Thomas</au><au>Christie, William C.</au><au>Day, Douglas G.</au><au>Lewis, Richard A.</au><au>Goodkin, Margot L.</au><au>Chen, Michelle</au><au>Wangsadipura, Veronica</au><au>Robinson, Michael R.</au><au>Bejanian, Marina</au><aucorp>Bimatoprost SR Study Group</aucorp><aucorp>for the Bimatoprost SR Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients</atitle><jtitle>Drugs (New York, N.Y.)</jtitle><stitle>Drugs</stitle><addtitle>Drugs</addtitle><date>2020-02-01</date><risdate>2020</risdate><volume>80</volume><issue>2</issue><spage>167</spage><epage>179</epage><pages>167-179</pages><issn>0012-6667</issn><eissn>1179-1950</eissn><abstract>Objective
The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
Methods
This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (
N
= 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
Results
At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
Conclusions
Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>31884564</pmid><doi>10.1007/s40265-019-01248-0</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-2077-659X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0012-6667 |
| ispartof | Drugs (New York, N.Y.), 2020-02, Vol.80 (2), p.167-179 |
| issn | 0012-6667 1179-1950 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7007425 |
| source | MEDLINE; SpringerNature Journals |
| subjects | Absorbable Implants Aged Antihypertensive Agents - administration & dosage Antihypertensive Agents - adverse effects Antihypertensive Agents - therapeutic use Bimatoprost - administration & dosage Bimatoprost - adverse effects Bimatoprost - therapeutic use Biodegradability Biodegradation Clinical trials Controlled release Dose-Response Relationship, Drug Drug dosages Evaluation Eye Female Glaucoma Glaucoma - diagnosis Glaucoma - drug therapy Humans Hypertension Injections, Intraocular Internal Medicine Internet resources Intraocular pressure Intraocular Pressure - drug effects Male Medicine Medicine & Public Health Middle Aged Original Original Research Article Patients Pharmacology/Toxicology Pharmacotherapy Pressure effects Prospective Studies Safety Safety measures Surgery Time Factors Transplants & implants Treatment Outcome |
| title | 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-18T10%3A39%3A06IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=24-Month%20Phase%20I/II%20Clinical%20Trial%20of%20Bimatoprost%20Sustained-Release%20Implant%20(Bimatoprost%20SR)%20in%20Glaucoma%20Patients&rft.jtitle=Drugs%20(New%20York,%20N.Y.)&rft.au=Craven,%20E.%20Randy&rft.aucorp=Bimatoprost%20SR%20Study%20Group&rft.date=2020-02-01&rft.volume=80&rft.issue=2&rft.spage=167&rft.epage=179&rft.pages=167-179&rft.issn=0012-6667&rft.eissn=1179-1950&rft_id=info:doi/10.1007/s40265-019-01248-0&rft_dat=%3Cproquest_pubme%3E2356726994%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2356726994&rft_id=info:pmid/31884564&rfr_iscdi=true |