Travoprost 40micrograms/ml / Timolol 5mg/ml eye drops

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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Purpose: To assess real-world efficacy and safety of standalone travoprost intracameral implant (iDose TR) implantation by a US glaucoma surgeon in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods: This non-randomized, retrospective, unmasked, consecutive case series included all cases of standalone iDose TR implantation from a single US glaucoma surgeon since the product’s approval by the US Food and Drug Administration (FDA) in December 2023. Patients were pseudophakic, had OAG or OHT, and had undergone prior SLT and/or bimatoprost intracameral implant injection (Durysta). Intraocular pressure (IOP), medications, and adverse events were evaluated through 3 months postoperatively. Results: All patients (n=65 eyes) were implanted with iDose TR and experienced no intraoperative complications. In the consistent cohort of eyes with 3-month follow-up data (n=54), mean IOP reduced from 19.6± 3.8 mmHg preoperatively to 13.1± 2.5 mmHg at 3 months (33.2% reduction, p=0.001). The percentage of eyes with IOP ≤ 15 mmHg increased from 11.1% preoperatively to 83.3% at 3 months (p=0.001). Mean number of IOP-reducing medications reduced from 0.28± 0.71 preoperatively to 0.0± 0.0 at 3 months (100% reduction; p=0.006). The percentage of eyes off topical medication increased from 85% preoperatively to 100% at 3 months. One eye was reported to have mild iritis at 1– 2 weeks postoperatively, and was treated with a topical prednisolone acetate taper. No secondary procedures occurred in any eye. Conclusion: Standalone implantation of the travoprost intracameral implant yielded statistically and clinically significant IOP and medication reductions through 3 months in eyes with prior SLT and/or bimatoprost intracameral implant injection with favorable safety. Plain Language Summary: This short-term real-world consecutive case series assesses the efficacy and safety of the novel travoprost intracameral implant (iDose TR) in actual clinical practice. Clinically and statistically significant reductions in intraocular pressure (IOP; 33.2% reduction) and topical medications were achieved, together with favorable safety. After the procedure, there was over a seven-fold increase in the percentage of eyes with IOP ≤ 15 mmHg, and 100% of eyes were free of topical medications (versus 85.2% preoperatively). This publication is the first real-world study in the literature to-date on this novel technology. Keywords: medication, pharmaceutical, implant, prostaglandin, glaucoma, iDose

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BACKGROUND/AIMS: To compare the efficacy and safety of a new preservative-free bimatoprost 0.01%/timolol 0.1% fixed combination (BTFC) eye gel with those of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (BTFC eye drops) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: In this phase III, international, multi-centre, randomised, parallel group, investigator-masked study, patients receiving a first-line monotherapy, having insufficiently controlled intraocular pressure (IOP) and requiring dual therapy were randomised to receive either BTFC eye gel or BTFC eye drops once daily for 12 weeks. The primary efficacy endpoint was the change in IOP from baseline to week 12 at 08:00 in the assessed eye. Further efficacy and safety endpoints were assessed as secondary outcomes. RESULTS: The mean±SD change in IOP from baseline to week 12 at 08:00 was -10.96±3.43 mmHg for the BTFC eye gel group and -11.14±3.56 mmHg for the BTFC eye drop group. The least-squares mean difference (BTFC eye gel minus BTFC eye drops) was -0.04±0.24 mmHg (95% CI -0.51 to 0.43 mmHg), with the upper bound of the 95% CI lower than the predefined margin of +1.5 mmHg at week 12 at 08:00. Similar IOP-lowering efficacy was demonstrated at all other timepoints. The safety profile was comparable between the treatment groups. No patients in the BTFC eye gel group discontinued the study due to a treatment-related adverse event compared with 8 (2.9%) patients in the BTFC eye drop group. CONCLUSION: Low-concentration BTFC eye gel can be considered as a safe and effective treatment in the therapeutic management of glaucoma and OHT.

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Glaucoma is one of the leading causes of blindness and its prevalence increases with age. The most common form, primary open-angle glaucoma, is a chronic, slowly progressive optic neuropathy characterised by the loss of retinal ganglion cells and their axons, leading to irreversible visual field loss. Elevated intraocular pressure (IOP) is the only modifiable risk factor for glaucoma. Reducing IOP to a level that is safe for the patient's eye has been shown to slow disease progression. Lowering IOP in open-angle glaucoma is achieved by eye drops, selective laser trabeculoplasty (SLT) and/or surgery. Many patients are treated with IOP-lowering eye drops, which require lifelong continuous instillation. However, as with other chronic, asymptomatic diseases, adherence to glaucoma treatment is poor for various reasons and is associated with faster disease progression. The purpose of this review is to discuss several sustained-release systems that have been investigated to reduce IOP over time, to address barriers to adherence and improve quality of life. Among these, non-invasive drug-eluting delivery systems such as contact lenses, punctal plugs, and conjunctival ocular inserts have not reached the market. Currently, only two intracameral implants have been approved by the Food and Drug Administration for single use due to corneal safety issues. The biodegradable bimatoprost implant releases the drug continuously for 4-6 months, and its effect on IOP may extend for up to 2 years in 25% of patients. The non-biodegradable intracameral implant releases travoprost for 36 months, when it needs to be removed. However, additional data are needed to assess safety following repeated administration, as well as in broader patient populations and in combination with other treatment approaches such as SLT. Several other biodegradable intracameral implants that release prostaglandin analogues are undergoing clinical trials. In the future, intraocular implants containing genetically modified cells that secrete neurotrophic factors may potentially offer an IOP-independent neuroprotective strategy, complementing existing IOP-lowering implants in glaucoma management.

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The increasing incidence of glaucoma and other ophthalmic diseases associated with elevated intraocular pressure has spurred the development of improved treatment strategies and therapies, aiming for better patient adherence and reduced treatment burden. While travoprost, a highly effective topical prostaglandin FP analogue, is frequently prescribed for patients with increased intraocular pressure, it presents challenges such as complex dosing regimens, poor adherence, and an increased risk of side effects stemming from chronic topical use. This comprehensive narrative review systematically investigates the contemporary status of travoprost intraocular implant, a device specifically engineered for sustained drug delivery to overcome the limitations of conventional topical travoprost formulations.The review synthesizes findings from studies discussing these implants and critically analyses the safety, efficacy profiles and patient tolerability detailed, including the two recent Phase 3 trials that led to its FDA approval, contextualizing them against other treatment modalities and therapies.While the advent of the iDose TR device marks a significant mark in the treatment and management of glaucoma and OHT, this review briefly explores other avenues for building on this technology and its potential impact on the future of glaucoma care.

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This retrospective study evaluated real-world outcomes of standalone iDose TR intracameral travoprost implant administration. Sixty-five consecutive standalone iDose TR implantations performed by a single surgeon were analyzed. Patients were pseudophakic, had a diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT), and had a history of a prior non-filtering glaucoma procedure (e.g., selective laser trabeculoplasty [SLT] or bimatoprost intracameral implant) performed beyond the preceding 6 months. Intraocular pressure (IOP) and medications were measured for 12 months postoperatively. Subgroup analysis was stratified by history of SLT treatment and glaucoma severity. If target IOP was not attained, secondary minimally invasive glaucoma surgery was performed instead of reinitiating or adding medication, according to the surgeon’s standard practice. The analysis was by intention to treat. At 12 months, mean IOP reduced significantly to 14.0 ± 2.9 mmHg from a baseline of 20.0 ± 4.0 mmHg (−28%, p &lt; 0.001). Eyes with IOPs ≤ 18, ≤15, and ≤12 mmHg increased significantly vs. baseline (36.9% to 92.3%, 10.8% to 73.8%, and 3.1% to 35.4%, respectively; all p &lt; 0.001), and 89.2% of the eyes were medication-free vs. 87.7% preoperatively. Mean 12-month IOP reduction showed nonsignificant differences between eyes with or without prior SLT (−26% and −31%, respectively; p = 0.907) and among mild/OHT, moderate, or severe glaucoma eyes (−28%, −23%, and −34%, respectively; p = 0.085). Postoperatively, one case each of transient corneal edema and retinal edema were observed, which self-resolved without sequelae. Thus, standalone travoprost implant administration significantly reduced IOP over 12 months in OAG and OHT, while maintaining a low medication burden. Similar IOP reductions were observed regardless of prior SLT treatment and glaucoma severity.

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Topical prostaglandin analogs (PGAs) are recommended as first-line therapy for the treatment of glaucoma. However, many patients do not achieve adequate IOP control with monotherapy and require additional agents. Combination therapy involving the use of two individual eye drops makes the medication instillation regimen complex, often leading to reduced adherence to treatment. Lack of adherence leads to poor outcomes. Fixed combinations of glaucoma pharmacotherapies can simplify the dosing regimen, increase adherence, and improve the quality of life (QoL). Latanoprost 0.005% and timolol maleate 0.5% fixed combination (LTFC) was the first PGA/βeta-blocker (BB) combination, launched in the European Union in 2001, and continues to be widely used. Studies have reported improved QoL and patient satisfaction with LTFC compared to monotherapy or other combination therapies. A high level of satisfaction with LTFC concerning tolerability and good adherence has also been reported. In several studies comparing LTFC with other monotherapies, LTFC consistently showed a higher reduction in intraocular pressure (IOP). Some studies have also shown that LTFC leads to a greater reduction in IOP than other combination therapies. Thus, LTFC can be useful in the management of patients with inadequate IOP control on monotherapy.

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Background: The present study assesses the effectiveness and tolerability of preservative-free travoprost in patients with primary open-angle glaucoma (POAG), focusing on intraocular pressure (IOP) reduction and ocular surface health over a six-month period. Methods: The study was prospectively designed and conducted at the University General Hospital of Alexandroupolis, Greece. A total of 45 patients diagnosed with either POAG or ocular hypertension (OHT) were included in the study; all were either newly diagnosed or had previously discontinued prostaglandin therapy due to intolerance. Of these, 39 participants completed the study. All subjects were administered preservative-free travoprost once daily. Clinical evaluations were conducted at baseline (T0), and at 1 month (T1), 3 months (T3), 6 months (T6) and 12 months (T12) following treatment initiation. The primary outcomes encompassed reductions in intraocular pressure (IOP), Schirmer test values, tear break-up time (TBUT), conjunctival hyperemia, as well as measurements of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness. Visual field parameters were also assessed. Results: A significant reduction in IOP was observed at T1, T3, T6 and T12 compared to baseline (p &lt; 0.01). Schirmer test scores improved significantly from T0 to all subsequent time points (p &lt; 0.01). Conjunctival hyperemia decreased significantly across follow-ups, while TBUT showed no significant change (p &gt; 0.05). No significant changes were noted in mean deviation (MD), pattern standard deviation (PSD), RNFL, or GCC thickness over six months. Conclusion: Preservative-free travoprost effectively reduces IOP while improving ocular surface health, particularly in tear production and conjunctival hyperemia.

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