Drugs / Travoprost

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) IDOSE TR — 2026-01-27 fda.gov ↗
Label expansion US (FDA) TRAVATAN Z — 2010-08-31 fda.gov ↗
Label expansion US (FDA) TRAVATAN — 2003-02-13 fda.gov ↗
Approved EU (EMA) Travatan — 2001-11-27 europa.eu ↗
Approved US (FDA) TRAVATAN — 2001-03-16 fda.gov ↗

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT04360174 Apr 2018 → May 2021 ocular hypertension, open-angle glaucoma Ocular Therapeutix, Inc. Completed No outcome recorded
Phase 1 NCT01845038 Apr 2013 → Mar 2014 glaucoma Ocular Therapeutix, Inc. Completed No outcome recorded
Phase 1 NCT01658839 Jan → Jul 2013 glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 210 trials
Phase 2 NCT07075718 Jun 2025 → Mar 2028 expected glaucoma Glaukos Corporation Recruiting No outcome recorded
Phase 2 NCT06152861 Nov 2023 → Aug 2024 ocular hypertension, open-angle glaucoma Glaukos Corporation Unknown No outcome recorded
Phase 2 NCT05335122 Mar 2022 → Jan 2024 ocular hypertension, open-angle glaucoma Ocular Therapeutix, Inc. Completed No outcome recorded
Phase 2 NCT06582732 Mar 2021 → Nov 2023 ocular hypertension, open-angle glaucoma Glaukos Corporation Completed No outcome recorded
Phase 2 NCT04615403 Nov 2020 → Feb 2022 open-angle glaucoma Glaukos Corporation Completed No outcome recorded
Phase 2 NCT02754596 Mar 2016 → Aug 2017 open-angle glaucoma Glaukos Corporation Completed No outcome recorded
Phase 2 NCT02371746 Jan 2015 → Feb 2019 glaucoma Envisia Therapeutics Completed No outcome recorded
Phase 2 NCT01298687 Feb → Apr 2011 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 2 NCT00637130 Oct 2007 → Jan 2008 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 2 NCT00527501 Aug → Dec 2007 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 329 trials · 1 met primary · 1 missed
Phase 3 NCT07495852 Feb 2026 → Jun 2028 expected glaucoma Glaukos Corporation Recruiting No outcome recorded
Phase 3 NCT06061718 Sep 2023 → Mar 2024 ocular hypertension, open-angle glaucoma Glaukos Corporation Unknown No outcome recorded
Phase 3 NCT03868124 Sep 2018 → Jun 2022 ocular hypertension, open-angle glaucoma Glaukos Corporation Completed No outcome recorded
Phase 3 NCT03519386 Jul 2018 → Apr 2022 ocular hypertension, open-angle glaucoma Glaukos Corporation Completed Met primary
Phase 3 NCT04061044 Jul 2018 → Feb 2020 open-angle glaucoma Ocular Therapeutix, Inc. Completed No outcome recorded
Phase 3 NCT02914509 Nov 2016 → Mar 2019 ocular hypertension, open-angle glaucoma Ocular Therapeutix, Inc. Completed Missed primary
Phase 3 NCT02390284 Sep 2015 → Oct 2024 glaucoma University of Miami Terminated No outcome recorded
Phase 3 NCT01652664 Sep 2012 → Mar 2014 glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 3 NCT01453855 Nov 2011 → Aug 2012 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 3 NCT01452009 Nov → Dec 2011 ocular hypertension, open-angle glaucoma Alcon Research Withdrawn No outcome recorded
Phase 432 trials · 2 met primary
Phase 4 NCT07228221 Jan 2026 → Aug 2031 expected open-angle glaucoma Jonathon Myers Recruiting No outcome recorded
Phase 4 NCT06848946 Jan 2025 → Aug 2026 overdue cataract 50 with or without glaucoma, ocular hypertension, open-angle glaucoma Glaukos Corporation Recruiting No outcome recorded
Phase 4 NCT06066645 Sep 2023 → May 2027 expected open-angle glaucoma Glaukos Corporation Recruiting No outcome recorded
Phase 4 NCT04577027 Jan 2021 → Jan 2022 vitiligo Assiut University Unknown No outcome recorded
Phase 4 NCT02796560 Jul 2016 → Sep 2017 ocular hypertension, open-angle glaucoma University of Sherbrooke Completed No outcome recorded
Phase 4 NCT03966560 Jan 2014 → Jan 2015 open-angle glaucoma Afyon Kocatepe University Hospital Completed No outcome recorded
Phase 4 NCT02003391 Dec 2013 → May 2015 ocular hypertension, open-angle glaucoma Alcon Research Completed Met primary
Phase 4 NCT01995136 Sep 2013 → Jun 2014 low tension glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 4 NCT01664039 Sep 2012 → Jun 2014 glaucoma, ocular hypertension Alcon Research Completed No outcome recorded
Phase 4 NCT01510145 Feb 2012 → May 2013 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase not applicable5 trials
— NCT01711177 Oct 2012 → Mar 2013 open-angle glaucoma University of Montreal Completed No outcome recorded
— NCT01491867 Dec 2011 → Oct 2012 glaucoma, ocular hypertension Semmelweis University Completed No outcome recorded
— NCT01361841 Jan 2009 → Jan 2012 ocular hypertension, open-angle glaucoma Centre de recherche du Centre hospitalier universitaire de Sherbrooke Unknown No outcome recorded
— NCT00441181 Jan → Dec 2008 neovascular glaucoma Federal University of São Paulo Withdrawn No outcome recorded
— NCT00435058 Sep 2005 → Apr 2006 glaucoma University of Sao Paulo Completed No outcome recorded
Phase not stated1 trial
— NCT04962009 Sep 2021 → Jul 2022 ocular hypertension Mati Therapeutics Inc. Completed No outcome recorded
Comparator or background therapy41 trials
Phase 1 NCT03965052 Comparator Apr → Jul 2019 glaucoma Laboratorios Sophia S.A de C.V. Completed No outcome recorded
Phase 2 NCT02312544 Comparator Nov 2014 → Sep 2015 glaucoma, ocular hypertension Ocular Therapeutix, Inc. Completed No outcome recorded
Phase 2 NCT02140060 Comparator Jun → Nov 2014 ocular hypertension, open-angle glaucoma Alcon Research Completed No outcome recorded
Phase 2 NCT01789736 Comparator Feb → Jun 2013 ocular hypertension, open-angle glaucoma Aerie Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01474135 Comparator Dec 2011 → Apr 2012 glaucoma, ocular hypertension Aerie Pharmaceuticals Completed No outcome recorded

News releases announcing trial results or a regulatory action · 28

DateIssuerRelease
2026-10-09 Glaukos Corporation Results Glaukos Announces Positive Topline Results from Phase 4 Prospective Randomized Controlled Clinical Trial Evaluating iDose® TR in Combination with Cataract Surgery glaukos.com ↗
The study achieved its primary efficacy endpoint, with iDose TR demonstrating statistically significant superiority in the reduction of mean diurnal intraocular pressure (IOP) when administered in conjunction with cataract surgery compared to cataract surgery alone.
2026-01-28 Glaukos Corporation Regulatory Glaukos Announces US FDA Approval of NDA Supplement Allowing for Re-Administration of iDose® TR glaukos.com ↗
2025-12-01 Alembic Pharmaceuticals Ltd. Regulatory 18th December, 2025 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution).
2025-01-14 Glaukos Corporation Results Glaukos Announces Positive Clinical Updates for its iDose® Sustained-Release Procedural Pharmaceutical Platform glaukos.com ↗
In addition,iDose TR continued to demonstrate excellent tolerability and a favorable safety profile through 36 months across both Phase 3 trials.
2024-05-06 Lupin Limited Regulatory Lupin Receives Approval from U.S. FDA for Travoprost Ophthalmic Solution USP lupin.com ↗
Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004%(Ionic Buffered Solution), to market a generic equivalent to the reference listed drug (RLD)Travatan Z® Ophthalmic Solution, 0.004%, of Sandoz Inc.
2024-04-06 Ocular Therapeutix, Inc. Results Ocular Therapeutix™ Announces Positive Phase 2 PAXTRAVA™ Glaucoma Data at the American Society of Cataract and Refractive Surgery 2024 Annual Meeting ocutx.com ↗
Ocular is very pleased to report positive six-month topline results for PAXTRAVA in the Phase 2 glaucoma study.
2023-12-14 Glaukos Corporation Regulatory Glaukos Announces FDA Approval of iDose®TR (travoprost intracameral implant) glaukos.com ↗
2023-05-05 Glaukos Corporation Regulatory Glaukos Announces FDA Acceptance of NDA Submission for iDose TR glaukos.com ↗
“The acceptance of the iDose TR NDA represents another important step in bringing this potential game-changing therapy one step closer to patients who may need a new treatment alternative,” said Thomas Burns, Glaukos chairman and chief executive officer.
2023-02-27 Glaukos Corporation Regulatory Glaukos Submits New Drug Application to U.S. FDA for iDose TR glaukos.com ↗
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iDose® TR.
2023-01-10 Glaukos Corporation Results Glaukos Announces Positive Results for iDose TR Exchange Trial, Highlighting Favorable Safety and Tolerability glaukos.com ↗
Results from the exchange trial demonstrated a second administration of iDose TR and removal of the original iDose TR implant was safe and well-tolerated, with the second iDose TR demonstrating a favorable safety profile over a 12-month evaluation period.
2022-09-07 Glaukos Corporation Results Glaukos Announces Positive Topline Outcomes for Both Phase 3 Pivotal Trials of iDose TR, Achieving Primary Efficacy Endpoints and Demonstrating Favorable Tolerability and Safety Profiles glaukos.com ↗
2022-01-11 Glaukos Corporation Results Glaukos’ iDose®TR Demonstrates Sustained IOP Reduction and Favorable Safety Profile Over 36 Months in Phase 2b Study glaukos.com ↗
today announced that its iDose® TR sustained-release travoprost implant continued to provide sustained substantial reductions in intraocular pressure (IOP) in a 36-month analysis of the 36-month Phase 2b clinical trial conducted under a U.S. Investigational New Drug (IND) protocol.

All press releases naming this drug 38 releases

DateIssuerRelease

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 125 sources stand behind the page.

FieldValueCited text
Known as travoprost “To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate...” NCT02312544 ↗
119

“a topical prostaglandin analogue eye drop. (latanoprost 0.005% 1 gtts in study eye qhs OR travoprost 0.004% 1 gtts in study eye qhs OR bimatoprost 0.01% 1 gtts in study eye qhs...” NCT01535768 ↗

“To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle...” NCT04360174 ↗

“Travacom(R) is a combination topical ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by complementary mechanisms of action.” NCT01159756 ↗

“Patients were surveyed using the Ocular Surface Disease Index (OSDI) to evaluate OSD symptoms prior to changing to travoprost BAK-free dosed once every evening.” PMID 19668762 ↗ Sep 2008

“Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.” NCT00690794 ↗

“Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)” NCT01168414 ↗

“Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed” NCT05241938 ↗

“travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily” NCT00912054 ↗

“OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release” NCT01845038 ↗

“Generic name: Travoprost * Distinctive denomination: Bristrio® (PRO-179)” NCT03965052 ↗

Show 109 more sources

Known as ENV515-1 “ENV515-1 Travoprost XR” NCT02371746 ↗
Known as ENV515-3 “ENV515-3 Travoprost XR” NCT02371746 ↗
Known as ENV515-3-2 “ENV515-3-2 Travoprost XR” NCT02371746 ↗
Known as Gen 2 Travoprost Intracameral Implant “Drug: Gen 2 Travoprost Intracameral Implant” NCT07075718 ↗
Known as iDose TR “iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery” NCT06848946 ↗
Known as OTX-TIC “To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle...” NCT04360174 ↗
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“OTX-TIC (travoprost) intracameral implant” NCT05335122 ↗

Known as OTX-TP “To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate...” NCT02312544 ↗
Known as TRAV “BAK-free travoprost 0.004% (TRAV) and BAK 0.02%-preserved bimatoprost 0.01% (BIM) during late-day time points in patients with open-angle glaucoma or ocular hypertension.” PMID 25432143 ↗ Nov 2014
Known as Travatan “Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)” NCT00758342 ↗
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“Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution)” NCT00471068 ↗

“Travatan/travoprost 0.004% ophthalmic solution one drop qhs for one year” NCT00705757 ↗

“Travoprost Ophthalmic Solution, 0.004% (Travatan), a prostaglandin” NCT00121147 ↗

“Generic name: Travoprost * Distinctive denomination: Travatan®” NCT03965052 ↗

“Travoprost 0.004% Ophthalmic Solution (Travatan)” NCT00763061 ↗

“Drug: Travoprost 0.004% (Travatan)” NCT00762645 ↗

NCT04868175 ↗

NCT00980473 ↗

NCT00767494 ↗

Known as TRAVATAN PQ (Travoprost ophthalmic solution with PQ, 0.004%) “TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%)” NCT02419508 ↗
Known as Travatan TM “Three of these are commonly used in North America: latanoprost (Latanoprost T, Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).” NCT01361841 ↗
Known as Travatan Z “PURPOSE: To compare the duration of action of travoprost ophthalmic solution 0.004% (Travatan Z) formulated without benzalkonium chloride (BAK) to travoprost ophthalmic...” PMID 18414108 ↗ Apr 2008
1

“Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy” NCT00444665 ↗

Known as Travatan(R) Z “Travatan(R) Z(travoprost ophthalmic solution)” NCT01474135 ↗
Action Activate “Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor agonist” PMID 11589866 ↗ Oct 2001
Modality Other / unclassified “Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor agonist” PMID 11589866 ↗ Oct 2001
Route Topical “1 drop each eye once daily” NCT00051168 ↗