Bimatoprost 300micrograms/ml / Timolol 5mg/ml eye drops 0.4ml unit dose preservative free

Netarsudil has been approved for lowering elevated intraocular pressure (IOP), showing effectiveness through two distinct mechanisms. It is also effective when used in combination with other therapies to enhance outcomes. This study aims to compare the drug's effectiveness with other treatments, both as a standalone and in combination therapies, while also assessing potential adverse effects to evaluate its overall safety and suitability. We systematically searched PubMed, Cochrane, Web of Science, and Scopus till the 7th of October. Data from eligible studies were extracted and combined using a frequentist network meta-analysis, presented as mean differences (MDs) for continuous outcomes and risk ratios (RRs) along with their 95% confidence intervals (CIs). We used the Cochrane risk-of-bias (ROB) tool to assess the quality of the included RCTs. Netarsudil 0.02%/latanoprost 0.005% fixed-dose combination (FDC) q.d. was the most effective in reducing IOP in one-, two-, and six-week follow-ups in addition to the three-month follow-up. The netarsudil-containing medication was associated with higher adverse events compared to other arms. Netarsudil 0.02%/latanoprost 0.005% FDC q.d. and bimatoprost 0.03%/timolol 0.5% FDC emerged as the most effective therapies for lowering IOP, with each showing significant advantages at different follow-up points. Both FDCs achieved substantial reductions in IOP and a high proportion of patients reaching target IOPs. However, safety profiles indicate that traditional therapies like latanoprost 0.005% and timolol 0.5% may have fewer side effects, including lower incidences of blurred vision, conjunctival hemorrhage, and conjunctival hyperemia.

Abstract licence: CC BY

Abstract Objective To compare the efficacy and safety of two fixed combination, preservative-free eye drops (bimatoprost 0.01% in combination with either timolol 0.1% or 0.5%) in a gel formulation, with bimatoprost 0.03%/timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods Phase II, randomized, investigator-masked, multicenter, 3-arm parallel group (Eudract No. 2017-002823-46). Eighty-six patients aged ≥18 years with OAG or OHT, with intraocular pressure (IOP) initially controlled for at least 6 months by a combination therapy of a dual prostaglandin and timolol or insufficiently controlled by first-line monotherapy were included. Patients were randomized to receive T4030a (bimatoprost 0.01%/timolol 0.1%; N = 29), T4030c (bimatoprost 0.01%/timolol 0.5%; N = 29) or bimatoprost 0.03%/timolol 0.5% (N = 28), administered once daily in the evening for 12 weeks. Primary endpoint was defined as change in IOP from day 1 to week 12 measured at 08:00 (±1 h). Further efficacy, safety and pharmacokinetic endpoints were assessed as secondary outcomes. Results The mean change in IOP from baseline to week 12 was −9.8 ± 2.1 mmHg for T4030a, −10.1 ± 2.5 mmHg for T4030c and −10.0 ± 2.8 mmHg for bimatoprost 0.03%/timolol 0.5%. All treatments were well tolerated with no safety issues identified in any group. In patients treated with T4030a, the systemic concentration of timolol was significantly lower after 12 weeks than in patients treated with T4030c or bimatoprost 0.03%/timolol0.5%. Conclusions These study results suggest that the preservative-free ophthalmic formulation of T4030a (bimatoprost 0.01%/timolol 0.1%) can be regarded as a useful tool in the therapeutic management of OAG and OHT.

Abstract licence: CC BY-NC-ND 4.0

PurposeTo assess the non-inferiority of a preservative-free fixed combination of timolol, dorzolamide, and brimonidine (TDB-FC/PF) compared to the same fixed combination with preservatives or concomitant therapy for treating patients with uncontrolled primary open-angle glaucoma (POAG).Patients and methodsThis Phase III study included 80 eyes from 43 patients randomized to receive TDB-FC/PF (preservative-free), TDB-FC (with preservatives), or TDB (triple therapy separately with preservatives) over 90 days. Follow-up visits took place at 2 and 4 weeks, and at 2 and 3 months. A mixed-effects model was used for the analysis. The primary outcome was intraocular pressure (IOP), measured at 9:00 a.m. and 11:00 a.m. Tolerability was assessed using the Ocular Comfort Index (OCI) and by evaluating conjunctival hyperemia and corneal staining. Safety assessments included best-corrected visual acuity, chemosis, visual fields, cup-to-disc ratio, central corneal thickness, and adverse event recording.ResultsAfter three months of treatment, the mean IOP decreased by 7.7, 8.3, and 8.3 mmHg at 9:00 a.m. and by 9.3, 9.8, and 9.6 mmHg at 11:00 a.m. for TDB-FC/PF, TDB-FC, and TDB, respectively (p = 0.624 and 0.753). The TDB-FC group showed a significant increase in conjunctival hyperemia severity at 2 and 4 weeks (p = 0.044 and 0.034, respectively). No significant differences were observed among groups for OCI, ocular surface staining, or safety parameters.ConclusionTDB-FC/PF effectively lowers IOP and is comparable to preserved fixed combinations or triple therapy in effectiveness. It is well tolerated, has a favorable safety profile, and offers the benefits of preservative-free formulations, which can enhance adherence in patients with POAG who need multiple medications.Trial registrationClinicalTrials.gov identifier, NCT03193333.

Abstract licence: CC BY-NC