Travoprost 40micrograms/ml eye drops

Objective: To evaluate and compare the effectiveness and safety of latanoprost, bimatoprost, travoprost, and tafluprost in lowering intraocular pressure (IOP) in individuals with glaucoma or ocular hypertension. Methods: We searched PubMed, Embase, Web of Science, and the Cochrane Library for randomized controlled trials (RCTs) published up to April 2025 comparing latanoprost, bimatoprost, travoprost, and tafluprost in adults with glaucoma or ocular hypertension. Primary outcomes were IOP reduction and conjunctival hyperemia. We assessed study quality using the Cochrane Risk of Bias 2.0 tool. Evidence certainty was evaluated with the CINeMA framework. A Bayesian network meta-analysis was conducted in RStudio. This review is registered with PROSPERO (CRD420251034803). Results: 25 RCTs published between 2001 and 2024, involving 4,045 participants, were included. All studies compared monotherapy with latanoprost, bimatoprost, travoprost, or tafluprost. Among these, bimatoprost showed the most effective reduction in intraocular pressure compared to latanoprost [mean difference (MD) 0.69; 95%confidence interval (CI) 0.28-1.1; SUCRA 95.6%; moderate confidence]. It also performed significantly better than travoprost (MD 0.64; 0.14-1.09; 39.2%; low confidence). No other comparisons showed statistically significant differences. Overall, the quality of evidence for this outcome ranged from low to moderate. In terms of safety, 16 trials, including 3,119 participants, reported on conjunctival hyperemia. Both bimatoprost [odds ratio (OR) 3.3; 2.5-4.5; 18.4%, high confidence] and travoprost (0.46; 0.33-0.63; 55%, high confidence) were associated with a higher risk of hyperemia compared to latanoprost. Bimatoprost also posed a significantly greater risk than travoprost (1.51; 1.06-2.16, high confidence). Conclusion: Bimatoprost provided the greatest IOP reduction but carried a higher risk of conjunctival hyperemia. Latanoprost and tafluprost offered balanced efficacy with better tolerability, making them suitable for patients with mild disease. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251034803.

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Intracameral prostaglandin implants represent a novel approach to managing intraocular pressure (IOP) in glaucoma patients, potentially addressing adherence issues associated with topical medications. This systematic review and meta-analysis evaluated the comparative safety and efficacy of intracameral prostaglandin implants versus topical timolol in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A systematic review and meta-analysis. We systematically searched PubMed, Embase, and Web of Science from inception to September 15, 2024. Randomized controlled trials (RCTs) comparing intracameral prostaglandin implants with topical timolol in adult patients with OAG or OHT were included. Primary outcomes were mean difference (MD) in IOP reduction and adverse events. Risk of bias was assessed using the Revised Cochrane risk-of-bias tool (RoB-2) at the outcome level, and certainty of evidence was evaluated using GRADE methodology. Seven articles from 5 unique RCTs (2,600 participants) were included. Intracameral prostaglandin implants demonstrated early superiority in IOP reduction, which converged with timolol by 12 weeks. At 10 days, implants showed greater IOP reduction compared to timolol (MD -0.942 mmHg, 95% CI -1.174 to -0.710). At 2 weeks (MD -0.787 mmHg, 95% CI -0.969 to -0.605) and 6 weeks (MD -0.317 mmHg, 95% CI -0.589 to -0.045), the difference remained statistically significant but diminished. By 12 weeks, the difference was no longer significant (MD -0.055 mmHg, 95% CI -0.276 to 0.166). Subgroup analyses suggested the 15 μg bimatoprost dose maintained efficacy longer than 10 μg or 75 μg travoprost doses. Adverse events were more common with implants than timolol, particularly conjunctival hyperemia, eye pain, and iritis. Corneal endothelial cell density decreased more with implants than timolol after 3-20 months (MD -201.640 cells/mm², 95% CI -284.697 to -118.583). Substantial heterogeneity (I² = 98-100%) was observed, warranting cautious interpretation. Intracameral prostaglandin implants are an effective alternative to timolol, offering early IOP reduction advantages that equilibrate over time. While the absolute IOP reduction (< 1 mmHg) falls below typical clinical significance thresholds, implants may offer advantages through improved treatment adherence. The benefit-risk assessment favors lower-dose implants, with the 15 μg bimatoprost implant showing the most sustained efficacy. Longer-term safety monitoring is warranted, particularly regarding corneal effects.

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INTRODUCTION: This prospective, multicenter, randomized, double-masked pivotal phase 3 trial evaluated the efficacy and safety of the travoprost intracameral SE-implant (slow-eluting implant, the intended commercial product) and FE-implant (fast-eluting implant, included primarily for masking purposes) compared to twice-daily (BID) timolol ophthalmic solution, 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: The trial enrolled adult patients with OAG or OHT with an unmedicated mean diurnal intraocular pressure (IOP) of ≥ 21 and unmedicated IOP ≤ 36 mmHg at each diurnal timepoint (8 A.M., 10 A.M., and 4 P.M.) at baseline. The eligible eye of each patient was administered an SE-implant, an FE-implant or had a sham administration procedure. Patients who received an implant were provided placebo eye drops to be administered BID and patients who had the sham procedure were provided timolol eye drops to be administered BID. The primary efficacy endpoint, for which the study was powered, was mean change from baseline IOP at 8 A.M. and 10 A.M. at day 10, week 6, and month 3. Non-inferiority was achieved if the upper 95% confidence interval (CI) on the difference in IOP change from baseline (implant minus timolol) was < 1.5 mmHg at all six timepoints and < 1 mmHg at three or more timepoints. The key secondary endpoint was mean change from baseline IOP at 8 A.M. and 10 A.M. at month 12. Non-inferiority at month 12 was achieved if the upper 95% CI was < 1.5 mmHg at both timepoints. Safety outcomes included treatment-emergent adverse events (TEAEs) and ophthalmic assessments. RESULTS: A total of 590 patients were enrolled at 45 sites and randomized to one of three treatment groups: 197 SE-implant (the intended commercial product), 200 FE-implant, and 193 timolol. The SE-implant was non-inferior to timolol eye drops in IOP lowering over the first 3 months, and was also non-inferior to timolol at months 6, 9, and 12. The FE-implant was non-inferior to timolol over the first 3 months, and also at months 6 and 9. Of those patients who were on glaucoma medication at screening, a significantly greater proportion of patients in the SE- and FE-implant groups (83.5% and 78.7%, respectively) compared to the timolol group (23.9%) were on fewer topical glaucoma medications at month 12 compared to screening (P < 0.0001, chi-square test). TEAEs, mostly mild, were reported in the study eyes of 39.5% of patients in the SE-implant group, 34.0% of patients in the FE-implant group and 20.1% of patients in the timolol group. CONCLUSIONS: The SE-travoprost intracameral implant demonstrated non-inferiority to timolol over 12 months whereas the FE-implant demonstrated non-inferiority over 9 months. Both implant models were safe and effective in IOP lowering in patients with OAG or OHT. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03519386.

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Prostaglandin analogs (PGA’s) or ocular hypotensive lipids are a significant class of medications primarily used in the management of glaucoma and ocular hypertension. Since their introduction in the late 20 th century, these compounds have revolutionized treatment protocols, offering a potent and effective means of lowering intraocular pressure (IOP). By mimicking the activity of naturally occurring prostaglandins, these analogs enhance the outflow of aqueous humor from the eye, thus reducing IOP and preventing damage to the optic nerve. Their role in clinical practice has expanded due to their relatively favorable side effect profile and once-daily dosing regimen, which promotes patient adherence. This review article delves into the pharmacodynamics and pharmacokinetics of the PGA’s, including latanoprost, bimatoprost, travoprost, tafluprost, and unoprostone. In addition, this article explores the molecular mechanisms underlying their therapeutic effects, the latest clinical trial data, and comparative studies that highlight their relative benefits and limitations. By synthesizing current knowledge and recent advancements, this article aims to provide a comprehensive overview for healthcare professionals, researchers, and students interested in the evolving landscape of glaucoma treatment.

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PURPOSE: A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication. METHODS: Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (n = 49). IOP was measured at baseline, day 1-2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters. RESULTS: Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months. CONCLUSION: The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.

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AIM: The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials designed to assess the efficacy and safety of the travoprost intracameral implant (slow-eluting [SE] implant in development as a new therapeutic and fast-eluting [FE] implant included for masking purposes) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: Subjects with OAG or OHT, on 0-3 intraocular pressure (IOP)-lowering medications, baseline unmedicated mean diurnal IOP of ≥ 21 mmHg, and IOP ≤ 36 mmHg at each baseline diurnal timepoint, received either a travoprost implant and twice-daily (BID) placebo eye drops or BID timolol 0.5% eye drops and a sham procedure. Subjects were followed through 12 months and assessed for IOP, reduction in topical IOP-lowering medications, and safety parameters including treatment-emergent adverse events (TEAEs). IOP at 8AM was prospectively collected at all study visits through 12 months and diurnal IOP, measured at 8AM, 10AM, and 4PM, was prospectively collected at baseline, day 10, week 6, and months 3 and 12. RESULTS: A total of 1150 subjects were randomized (385 FE implant, 380 SE implant, and 385 sham/timolol) across the two trials. Statistical non-inferiority to timolol and clinically relevant reductions in 8AM IOPs were demonstrated at month 12. In more detail, both implant groups demonstrated statistical non-inferiority to timolol and clinically relevant reductions from baseline in mean diurnal IOP at all visits over the 12-month evaluation period when diurnal IOP was collected. Additionally, both implant groups demonstrated robust treatment effect based on 8AM average IOP from day 10 through the specified visit which ranged from day 10 to month 12 from 6.9 to 8.5 mmHg in the FE implant group; 6.8 to 8.5 mmHg in the SE implant group; and 7.3 to 7.5 mmHg in the sham/timolol group. With regards to reduction in topical pharmacotherapy, at month 12, 77.6% of FE and 81.4% of SE implant eyes were completely free of all topical IOP-lowering medications and a significantly greater proportion of FE and SE implant eyes (89.9% and 93.0%) versus sham/timolol eyes (66.9%) were on the same or fewer topical IOP-lowering medications compared with pre-study (p < 0.0001). Furthermore, of subjects on topical IOP medications at screening, a significantly greater proportion of FE implant (80.2%) and SE implant (85.1%) eyes versus sham/timolol (22.8%) eyes were on fewer topical IOP-lowering medications at month 12 compared with pre-study (p < 0.0001). Lastly, of SE implant eyes on same or fewer topical IOP-lowering medications at month 12, the average through month 12 decreased by 0.9 medications, and of those SE implant eyes on fewer topical IOP-lowering medications compared with pre-study, the average through month 12 decreased by 1.4 medications. The most common TEAEs related to study treatment were hyperemia (conjunctival or ocular), iritis, and IOP increased. CONCLUSION: The travoprost intracameral implant demonstrated robust IOP-lowering efficacy that was sustained and statistically non-inferior to timolol over the entire 12 months, resulting in a significant reduction in topical IOP-lowering medication use, with the majority of SE implant eyes remaining completely free of all topical IOP-lowering medications. In addition, the implant demonstrated a favorable safety and tolerability profile based on this pooled 12-month analysis of two pivotal trials. TRIAL REGISTRATION: ClinicalTrials.gov identifiers NCT03519386 (registered May 09, 2018) and NCT03868124 (registered March 08, 2019).

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To date, the ophthalmic application of liquid crystalline nanostructures (LCNs) has not been thoroughly reconnoitered, yet they have been extensively used. LCNs are primarily made up of glyceryl monooleate (GMO) or phytantriol as a lipid, a stabilizing agent, and a penetration enhancer (PE). For optimization, the D-optimal design was exploited. A characterization using TEM and XRPD was conducted. Optimized LCNs were loaded with the anti-glaucoma drug Travoprost (TRAVO). Ex vivo permeation across the cornea, in vivo pharmacokinetics, and pharmacodynamic studies were performed along with ocular tolerability examinations. Optimized LCNs are constituted of GMO, Tween® 80 as a stabilizer, and either oleic acid or Captex® 8000 as PE at 25 mg each. TRAVO-LNCs, F-1-L and F-3-L, showed particle sizes of 216.20 ± 6.12 and 129.40 ± 11.73 nm, with EE% of 85.30 ± 4.29 and 82.54 ± 7.65%, respectively, revealing the highest drug permeation parameters. The bioavailability of both attained 106.1% and 322.82%, respectively, relative to the market product TRAVATAN®. They exhibited respective intraocular pressure reductions lasting for 48 and 72 h, compared to 36 h for TRAVATAN®. All LCNs exhibited no evidence of ocular injury in comparison to the control eye. The findings revealed the competence of TRAVO-tailored LCNs in glaucoma treatment and suggested the potential application of a novel platform in ocular delivery.

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