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Indian Journal of Ophthalmology Jun 2022The burden of irreversible vision loss from Glaucoma continues to rise. While the disease pathogenesis is not well understood, intraocular pressure (IOP) is the only... (Review)
Review
The burden of irreversible vision loss from Glaucoma continues to rise. While the disease pathogenesis is not well understood, intraocular pressure (IOP) is the only modifiable risk factor identified to prevent glaucomatous vision loss. Medical management remains the first-line of treatment in most adult glaucomas and the evolution of medical therapy for glaucoma has followed an exponential curve. This review tracks the rapid development of new medications and drug delivery systems in the recent years. Introduction of Rho kinase inhibitors with an entirely new mechanism of action from that of the currently used anti glaucoma medications has been a significant milestone. Latanoprostene Bunod is a novel, single molecule which provides two active metabolites that work through two different pathways for reducing intra ocular pressure. Bimatoprost implants and travoprost punctum plugs attempt to ease chronic medication use in glaucoma patients. Nanotechnology is an evolving route of drug delivery. Role of cannabinoids in medical management of glaucoma remain equivocal. The relatively short term effect on IOP, the risks of developing tolerance and side effects impacting patients' neurocognitive health greatly outweigh the potential benefit. Research on Latrunculin B, Adenosine receptor agonists, Specific gene silencing and Stem cell therapy are poised to make an impact on glaucoma treatment. While there is some evidence to support the role of Brimonidine in neuroprotection, further research is needed to clarify the role of Memantine and Neurotrophins. Evidence for benefit from dietary supplementation with Alpha lipoic acid, Forskolin , and Ginko Biloba is limited.
Topics: Antihypertensive Agents; Bimatoprost; Glaucoma; Humans; Intraocular Pressure; Tonometry, Ocular
PubMed: 35647957
DOI: 10.4103/ijo.IJO_2239_21 -
Ophthalmology Jan 2016Primary open-angle glaucoma (POAG) is a highly prevalent condition worldwide and the most common cause of irreversible sight loss. The objective is to assess the... (Meta-Analysis)
Meta-Analysis Review
TOPIC
Primary open-angle glaucoma (POAG) is a highly prevalent condition worldwide and the most common cause of irreversible sight loss. The objective is to assess the comparative effectiveness of first-line medical treatments in patients with POAG or ocular hypertension through a systematic review and network meta-analysis, and to provide relative rankings of these treatments.
CLINICAL RELEVANCE
Treatment for POAG currently relies completely on lowering the intraocular pressure (IOP). Although topical drops, lasers, and surgeries can be considered in the initial treatment of glaucoma, most patients elect to start treatment with eye drops.
METHODS
We included randomized controlled trials (RCTs) that compared a single active topical medication with no treatment/placebo or another single topical medication. We searched CENTRAL, MEDLINE, EMBASE, and the Food and Drug Administration's website. Two individuals independently assessed trial eligibility, abstracted data, and assessed the risk of bias. We performed Bayesian network meta-analyses.
RESULTS
We included 114 RCTs with data from 20 275 participants. The overall risk of bias of the included trials is mixed. The mean reductions (95% credible intervals) in IOP in millimeters of mercury at 3 months ordered from the most to least effective drugs were as follows: bimatoprost 5.61 (4.94; 6.29), latanoprost 4.85 (4.24; 5.46), travoprost 4.83 (4.12; 5.54), levobunolol 4.51 (3.85; 5.24), tafluprost 4.37 (2.94; 5.83), timolol 3.70 (3.16; 4.24), brimonidine 3.59 (2.89; 4.29), carteolol 3.44 (2.42; 4.46), levobetaxolol 2.56 (1.52; 3.62), apraclonidine 2.52 (0.94; 4.11), dorzolamide 2.49 (1.85; 3.13), brinzolamide 2.42 (1.62; 3.23), betaxolol 2.24 (1.59; 2.88), and unoprostone 1.91 (1.15; 2.67).
CONCLUSIONS
All active first-line drugs are effective compared with placebo in reducing IOP at 3 months. Bimatoprost, latanoprost, and travoprost are among the most efficacious drugs, although the within-class differences were small and may not be clinically meaningful. All factors, including adverse effects, patient preferences, and cost, should be considered in selecting a drug for a given patient.
Topics: Antihypertensive Agents; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 26526633
DOI: 10.1016/j.ophtha.2015.09.005 -
Indian Journal of Ophthalmology May 2023Glaucoma is a major cause of irreversible blindness worldwide. Reducing intraocular pressure (IOP) is currently the only approach to prevent further optic nerve head... (Review)
Review
Glaucoma is a major cause of irreversible blindness worldwide. Reducing intraocular pressure (IOP) is currently the only approach to prevent further optic nerve head damage. Pharmacotherapy is the mainstay of treatment for glaucoma patients. In recent years, a significant milestone in glaucoma treatment has been a transition to prostaglandin analogs (PGAs) as the first line of drugs. The rapid shift from traditional β-blockers to PGAs is primarily due to their excellent efficacy, convenient once-a-day usage, better diurnal control of IOP, and systemic safety profiles. This review article aims to provide information regarding the various PGAs in practice and also the newer promising drugs.
Topics: Humans; Bimatoprost; Cloprostenol; Travoprost; Latanoprost; Prostaglandins F, Synthetic; Ophthalmology; Antihypertensive Agents; Amides; Prostaglandins, Synthetic; Glaucoma; Intraocular Pressure
PubMed: 37203029
DOI: 10.4103/IJO.IJO_2706_22 -
Clinical Ophthalmology (Auckland, N.Z.) 2016The preservative benzalkonium chloride (BAK) is used to preserve several topical, intraocular pressure (IOP)-lowering glaucoma medications but can cause tolerability...
INTRODUCTION
The preservative benzalkonium chloride (BAK) is used to preserve several topical, intraocular pressure (IOP)-lowering glaucoma medications but can cause tolerability concerns that may lead to decreased adherence to treatment and ultimately diminish the effectiveness of IOP control. The study aimed to determine the efficacy and tolerability of BAK-free travoprost preserved with polyquaternium-1 in glaucoma patients switched from BAK-preserved latanoprost or bimatoprost.
METHODS
This 12-week, open-label study was conducted in Europe between December 2011 and February 2013. We enrolled adult patients with open-angle glaucoma or ocular hypertension who were receiving BAK-preserved latanoprost 0.005% or bimatoprost 0.01% and, in the opinion of the investigator, would benefit from transition to BAK-free travoprost 0.004% preserved with polyquaternium-1 because of tolerability concerns. Assessments included IOP, proportion of patients with IOP ≤18 mmHg, ocular surface status, hyperemia, patient treatment preference, and adherence. Adverse events were recorded throughout the study.
RESULTS
Of the 202 patients screened, 187 patients were included in the intent-to-treat population (mean age, 66.6 years; range, 19-90 years). The mean IOP significantly reduced from baseline (17.0 mmHg) to week 6 (mean change, -1.17 mmHg; <0.001) and week 12 (-1.16 mmHg; <0.001). At week 12, more patients achieved IOP ≤18 mmHg (81.2% versus 73.3% at baseline), and ocular surface disease severity improved from baseline to week 12. Most patients preferred BAK-free travoprost (74.9%) versus their previous medication and were very confident in their adherence (84.1%). Reduced visual acuity and eye pruritus were the most common adverse events (2.5% each).
CONCLUSION
BAK-free travoprost 0.004% preserved with polyquaternium-1 was efficacious and well tolerated and may be an advantageous prostaglandin analog option for patients with open-angle glaucoma or ocular hypertension who are intolerant to BAK-preserved latanoprost or bimatoprost.
PubMed: 27799736
DOI: 10.2147/OPTH.S112711 -
Journal of Current Glaucoma Practice 2016Comparative evaluation of pharmaceutical characteristics of three marketed generic vs branded travoprost formulations. (Review)
Review
PURPOSE
Comparative evaluation of pharmaceutical characteristics of three marketed generic vs branded travoprost formulations.
MATERIALS AND METHODS
Three generic travoprost formulations and one branded (Travatan without benzalkonium chloride) formulation (10 vials each), obtained from authorized agents from the respective companies and having the same batch number, were used. These formulations were coded and labels were removed. At a standardized room temperature of 25°C, the drop size, pH, relative viscosity, and total drops per vial were determined for Travatan (Alcon, Fort Worth, TX, USA) and all the generic formulations. Travoprost concentration in all four brands was estimated by using liquid chromatography-coupled tandem mass spectrometry LCMS.
RESULTS
Out of the four formulations, two drugs (TP 1 and TP 4) were found to follow the United States Pharmacopoeia (USP) limits for ophthalmic formulation regarding drug concentration, while the remaining two drugs failed due to the limits being either above 110% (TP 2) or below 90% (TP 3). Two of them (TP 1 and TP 2) had osmolality of 313 and 262 mOsm respectively, which did not comply with the osmolality limits within 300 mOsm (+ 10%). The pH of all the formulations ranged between 4.7 and 5.9, and the mean drop size was 30.23 ± 6.03 uL. The total amount of drug volume in the bottles varied from 2.58 ± 0.15 to 3.38 ± 0.06 mL/bottle.
CONCLUSION
There are wide variations in the physical properties of generic formulations available in India. Although some generic drugs are compliant with the pharmacopeia standards, this study underscores the need for a better quality control in the production of generic travoprost formulations. How to cite this article: Wadhwani M, Mishra SK, Angmo D, Velpandian T, Sihota R, Kotnala A, Bhartiya S, Dada T. Evaluation of Physical Properties of Generic and Branded Travoprost Formulations. J Curr Glaucoma Pract. 2016;10(2):49-55.
PubMed: 27536047
DOI: 10.5005/jp-journals-10008-1201 -
Turkish Journal of Ophthalmology Apr 2020The use of benzalkonium chloride (BAC)-preserved medications is associated with ocular surface disease (OSD) that can negatively affect quality of life (QoL) in glaucoma... (Clinical Trial)
Clinical Trial
OBJECTIVES
The use of benzalkonium chloride (BAC)-preserved medications is associated with ocular surface disease (OSD) that can negatively affect quality of life (QoL) in glaucoma patients. This study aimed to compare QoL and correlate it with OSD in glaucoma patients receiving BAC-preserved and BAC-free travoprost.
MATERIALS AND METHODS
A total of 110 subjects were divided into 3 groups: 40 primary open-angle glaucoma (POAG) patients using BAC-preserved travoprost, 40 POAG patients using BAC-free travoprost, and 30 age-matched controls. All patients were assessed using a single interviewer-administered format of the Ocular Surface Disease index (OSDI) and Glaucoma Quality of Life-15 (GQL-15) questionnaires.
RESULTS
Mean GQL-15 score in the BAC group was significantly higher than in the BAC-free group (24.71±7.42 vs. 17.58±3.06; p<0.05). The mean difference in GQL-15 scores between controls and the BAC-free group (1.24) was insignificant (p>0.05). There was a strong positive correlation between OSDI scores and GQL-15 scores in all the groups (r values: BAC: 0.63, BAC-free: 0.23, controls: 0.29), with higher OSDI scores (severe OSD) associated with higher GQL-15 scores (worse QoL). Cronbach's alpha was 0.84 for GQL-15 and 0.75 for OSDI.
CONCLUSION
BAC-preserved travoprost leads to higher OSDI scores, which correlate strongly with poor QoL scores as compared to BAC-free travoprost. The use of BAC-free formulations should be encouraged to reduce the onset or worsening of OSD and impaired QoL in glaucoma patients.
Topics: Antihypertensive Agents; Benzalkonium Compounds; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Preservatives, Pharmaceutical; Quality of Life; Travoprost
PubMed: 32366084
DOI: 10.4274/tjo.galenos.2019.29000 -
Clinical Ophthalmology (Auckland, N.Z.) 2014Prostaglandins are approved by the European Glaucoma Society guidelines as first-line treatment for glaucoma. This review focuses on latanoprost, an ester prodrug of... (Review)
Review
Prostaglandins are approved by the European Glaucoma Society guidelines as first-line treatment for glaucoma. This review focuses on latanoprost, an ester prodrug of prostaglandin (PG) F2α, which was the first of the currently available topical PGF2α analogs to be launched for glaucoma or ocular hypertension and which still accounts for the majority of prescriptions. It is better absorbed than the parent compound through the cornea, and peak concentration of the active drug is in the aqueous humor 1-2 hours after topical dosing (15-30 ng/mL). Metabolism occurs mainly in the liver. Latanoprost (0.005%) has been very well studied in clinical trials and meta-analyses that show it to be generally as effective as the other PG analogs (bimatoprost, travoprost, and tafluprost) and more effective than timolol, dorzolamide, and brimonidine. Latanoprost has good short- and long-term safety and tolerability profiles. In common with other prostaglandins, it lacks systemic effects, but can cause ocular adverse events such as conjunctival hyperemia, pigmentation of the iris, periocular skin or eyelashes, hypertrichosis, and ocular surface effects or irritation. Latanoprost is significantly better tolerated than either bimatoprost or travoprost. Patients treated with latanoprost have better compliance and persist with therapy longer than those that are given other drugs. An improved formulation of latanoprost without the preservative benzalkonium chloride has recently been developed. It is as effective as conventional latanoprost, has a lower incidence of hyperemia, and can be stored at room temperature. In conclusion, latanoprost has the best efficacy-tolerability ratio of the PG analogs available for glaucoma treatment, and has good compliance and persistence. These factors should be improved further by the recent development of preservative-free latanoprost.
PubMed: 25328381
DOI: 10.2147/OPTH.S59162 -
Journal of Ophthalmology 2021Within the clinical setting, some patients have been identified as lacking in response to PGAs. This meta-analysis study aimed to evaluate the responsiveness of... (Review)
Review
AIM
Within the clinical setting, some patients have been identified as lacking in response to PGAs. This meta-analysis study aimed to evaluate the responsiveness of latanoprost, travoprost, bimatoprost, and tafluprost in OAG/OHT patients, latanoprost nonresponders (LNRs), and the IOP-reducing efficacy and safety.
METHODS
A literature search was conducted on PubMed, Embase, and the Cochrane Controlled Trials Register. The primary clinical endpoint was the number of responders at the end of the study. The secondary clinical endpoint was the IOP reduction at the endpoint from baseline. Safety evaluation included five common adverse events: conjunctival hyperemia, hypertrichosis, ocular burning, ocular itching, and foreign-body sensation.
RESULTS
Eleven articles containing ten RCTs were included in this meta-analysis study. The results highlighted that, in the OAG/OHT population, there was no statistically significant difference in the responsiveness of the four PGAs. Bimatoprost had a better IOP-reducing efficacy than latanoprost. There was no significant difference in the IOP-reducing efficacy of travoprost, latanoprost, and tafluprost. In LNRs, the responsiveness of bimatoprost, travoprost, and latanoprost did not show statistical differences. Bimatoprost reduced IOP with a greater extent than latanoprost and travoprost in LNRs, while there was no significant difference in the IOP-reducing efficacy of travoprost and latanoprost. No serious adverse events occurred with the treatment of the four PGAs. The prevalence of conjunctival hyperemia due to bimatoprost or tafluprost was significantly higher than that of latanoprost. Other adverse events had no significant difference between the four drugs.
CONCLUSION
The existing studies cannot prove that latanoprost, travoprost, bimatoprost, and tafluprost have different responsiveness in OAG/OHT patients. Switching to bimatoprost or travoprost cannot achieve a significant improvement in responsiveness in LNRs. Bimatoprost has a better IOP-reducing efficacy than latanoprost and travoprost. No serious adverse events occurred during treatment with any medication we studied.
PubMed: 34123413
DOI: 10.1155/2021/5586719 -
Clinical Ophthalmology (Auckland, N.Z.) 2015Travoprost is a prostaglandin analogue widely used for reducing intraocular pressure (IOP) in patients affected with glaucoma and ocular hypertension. It exerts its... (Review)
Review
Travoprost is a prostaglandin analogue widely used for reducing intraocular pressure (IOP) in patients affected with glaucoma and ocular hypertension. It exerts its ocular hypotensive effect through the prostaglandin FP receptors, located in the ciliary muscle and the trabecular meshwork. Several studies have shown that topical administration of travoprost induces a mean IOP reduction ranging from 25% to 32%, and sustained throughout the 24-hour cycle. When compared with timolol, travoprost is more effective at reducing IOP, while generally no difference has been found in the head-to-head comparison with other prostaglandin analogues. The fixed combination of travoprost and timolol has demonstrated a hypotensive efficacy comparable to the concomitant administration of the two drugs. Recently, a new preservative-free formulation of travoprost 0.004% has been marketed for reducing tolerability-related problems in subjects affected with ocular surface disease. Low rates of topical and systemic adverse reactions, strong ocular hypotensive efficacy, and once-a-day dosing make travoprost a first-line treatment for patients affected with elevated IOP.
PubMed: 25914522
DOI: 10.2147/OPTH.S61444