Generic Latanoprost Research Articles

Comparative study of the efficacy and safety of 0.005 % Glaumax and 0.005 % Xalatan

PURPOSE. To compare hypotensive efficiency and safety of generic latanoprost 0.005 % (Glaumax, “KEVELT AS”, Estonia) and original latanoprost 0.005 % (Xalatan, “Pfizer Inc”, USA) in glaucoma patients. METHODS. The study included patients with newly diagnosed primary open-angle glaucoma or patients with primary open-angle glaucoma on carbonic anhydrase inhibitor monotherapy 4 days after cease of treatment (the “wash-out” period). Study patients were divided into 2 groups. Group 1 consisted of 25 patients (30 eyes) with initial and advanced stages of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.15 ± 1.48 mm Hg. This group of patients was prescribed instillations of 0.005 % Glaumax eye drops 1 time per day. Group 2 also included 25 patients (30 eyes) with initial stage of newly diagnosed POAG and initial corneal-compensated IOP (IOPcc) of 25.08 ± 1.42 mm Hg. Group 2 patients were prescribed instillations of 0.005 % Xalatan eye drops 1 time per day. IOPcc was measured initially after the washout period, then 1 and 2 months after the start of the new therapy. Additionally, all patients were assessed for tear film break up time (Norn’s test) at each follow-up point. RESULTS. After 1 month, IOPcc in groups 1 and 2 was 17.36 ± 1.39 and 18.09 ± 1.45 mm Hg, respectively; after 2 month, 17.87 ± 1.30 and 18.54 mm Hg, respectively. The Norn’s test results in groups 1 and 2 after 1 month were 8 (7; 9.75) and 8 (6; 9.75) seconds, after 2 months it was 8.5 (8; 9) and 8 (7; 10) seconds, respectively, which corresponded to the initial stage of the "dry eye" syndrome. No statistically significant intergroup differences were found in any of the cases. CONCLUSION. Xalatan 0.005 and Glaumax 0.005 have comparable efficacy and tolerability, and both help achieve persistent stabilization of IOP. The option for a single-instillation regimen is convenient for the patients.

The physicochemical properties of preserved and preservative‐free latanoprost eye drops and their impact on human conjunctival goblet cells

AbstractPurposeTo investigate the impact on human conjunctival goblet cell (GC) survival and mucin release for benzalkonium chloride (BAK) preserved and preservative‐free (PF) 0.005% (w/v) latanoprost (LT) eye drops, and to compare the eye drops’ physicochemical properties.MethodsGC cultures were established from human conjunctival donor tissue. The impact of eye drops on GC survival was assessed using lactate dehydrogenase (LDH) and tetrazolium dye (MTT) colorimetric assays. Mucin release was evaluated through mucin‐specific immunostaining. pH‐value, osmolality, drop mass and surface tension for all LT eye drops were measured.ResultsAfter application with PF‐LT for 30 minutes (min), the GC survival was maintained (p = 0.7043), while all BAK‐LT eye drops reduced survival to approximately 70% (p<0.0001). Following application with PF‐LT for 30 min, mucin was found around the GC nucleus, as seen in the vehicle control, indicating no secretion. In contrast, BAK‐LT caused diffuse staining of mucin, similar to the secretagogue histamine, indicating stimulation of secretion. The pH of the BAK‐LT and PF‐LT eye drops were 6.0‐6.9 and 6.8, respectively. The osmolality was 258‐288 mOsm/kg for the BAK‐LT eye drops and 276 for PF‐LT eye drop. The mean drop mass was 26‐31 mg for the BAK‐LT eye drops and 30mg for PF‐LT. The surface tension was lower for all BAK‐LT eye drops (31.1‐32.1 mN/m) compared to PF‐LT (42 mN/m).ConclusionsPF‐LT compared to various branded and generic LT preparations containing BAK should be used to improve goblet cell tolerability and ocular surface health.

Impact of benzalkonium chloride-preserved and preservative-free latanoprost eye drops on cultured human conjunctival goblet cells upon acute exposure and differences in physicochemical properties of the eye drops

ObjectiveTo investigate the short-term impact on human conjunctival goblet cell (GC) survival and mucin release of acute exposure to benzalkonium chloride (BAK) preserved and preservative-free (PF) 0.005% (w/v) latanoprost (LT)...

Comparative Study between Generic versus Brand Latanoprost in treatment of Open Angle Glaucoma Patients

Abstract Background Glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells. Degeneration of these nerves results in cupping, a characteristic appearance of the optic disc and visual loss. Glaucoma can remain asymptomatic until it is severe, resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it. Without adequate treatment glaucoma can progress to visual disability and eventual blindness which is irreversible. Many types of glaucoma are usually controlled with daily medical treatment consisting of eye drops lowering IOP. Some do this by reducing the amount of aqueous fluid the eye makes. Others reduce pressure by helping aqueous fluid flow better through the drainage angle. A generic medicine is defined as a product having the same qualitative and quantitative composition in active ingredients, as well as the same pharmaceutical form, as the reference medicine and whose bioequivalence has been shown by adequate bioavailability studies, also its low price makes it more affordable. Aim of the Work To evaluate intra ocular pressure control and compliance of the patient using a generic prostaglandins eye drops in comparison to a brand one in the management of glaucoma patients and its safety profile, to determine the value of the generic drug in glaucoma management. Patients and Methods This is a prospective interventional cross over study was done on 30 patients recruited from Glaucoma Clinic of National Eye Center, Rod El Farag from January 2019 to July 2019. Results The mean baseline IOP of both main groups on day 0 was 23.9 ± 3.3 mmHg at 9 AM, 23.6 ± 2.7 mmHg at 1 PM, 23.6 ± 2.3 mmHg at 6 PM before treatment with original or generic latanoprost (P = 1). Both treatments reduced the IOP from baseline (day 0 of each drug) at each time-point, and for the three diurnal IOP measurements at 3 months. Original latanoprost had a greater efficacy than generic latanoprost after 3 months, Original Latanoprost reduced the IOP after 3 months of treatment by -8.6 ± 0.84 mmHg at 9.00 AM, 7.4 ± 1.2 mmHg at 1.00 PM hours and -6.4 ± 1.8 mmHg at 6.00 PM, While Generic latanoprost reduced IOP after 3 months by -7.03 ± 0.95, -5.8 ± 1.1 and -4.9 ± 1.8 mmHg, respectively. Conclusion Original latanoprost has a tendency of better efficacy and tolerability with low incidence of conjunctival hyperaemia and ocular irritation compared with the generic latanoprost in management of open angle glaucoma patient.

Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017.

Prostaglandin analogs are the most effective treatment for glaucoma, a common condition among older adults. Despite the availability of generic drugs, the costs associated with these prescription drugs are rising. To characterize Medicare prescription drug plan (PDP) formulary coverage and beneficiary out-of-pocket cost for prostaglandin analogs from 2009 to 2017 and Medicare spending on prostaglandin analogs from 2013 to 2017. This study was a retrospective analysis. We used 2009, 2013, and 2017 Medicare PDP formulary, beneficiary cost, and pricing files to determine beneficiary first-prescription out-of-pocket costs and plan coverage (unrestricted, restricted, or not covered) of branded latanoprost 0.005%, travoprost 0.004%, bimatoprost 0.03% and 0.01%, and tafluprost 0.0015% and of generic latanoprost 0.005% and generic bimatoprost 0.03%. We also used Medicare Part D spending data to determine aggregate spend in 2013 and 2017. In 2009, 92% of plans covered branded latanoprost, 83% covered branded bimatoprost; and 49% covered branded travoprost, whereas in 2017, 6% of plans covered branded latanoprost; 95% covered branded bimatoprost; and 96% covered branded travoprost. Although generic latanoprost was universally covered, generic bimatoprost was only covered by 35% of plans in 2017. Median out-of-pocket cost of branded prostaglandins without generic equivalents was $35 (IQR = $29-$40) in 2009, $45 (IQR = $42-$101) in 2013, and $90 (IQR = $45-$159) in 2017. Median out-of-pocket cost of all available generic prostaglandins was $10 (IQR = $5-$33) in 2013 and $10 (IQR = $4-$15) in 2017. In 2013, Medicare spent $733 million on prostaglandin analogs; in 2017, this increased to $1.09 billion, with $943 million (86%) spent on branded prostaglandins and $148 million (14%) spent on generics. Medicare PDP coverage of branded prostaglandins remained stable from 2009 to 2017. While median beneficiary out-of-pocket costs associated with generic prostaglandins remained stable, those associated with branded prostaglandins increased nearly 3-fold. Research reported in this publication was supported by National Heart, Lung and Blood Institute of the National Institutes of Health under Award Number T35HL007649. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health. Shah has received research support through Mayo Clinic from the U.S. Food and Drug Administration (FDA) to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative (TCPI); the Agency for Healthcare Research and Quality (U19HS024075, R01HS025164, R01HS025402, R03HS025517); and the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R56HL130496, R01HL131535), National Science Foundation, and the Patient Centered Outcomes Research Institute to develop a clinical data research network. Ross has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices (U01FD004585); the FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers of Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting (HHSM-500-2013-13018I); the Agency for Healthcare Research and Quality (R01HS022882); the National Heart, Lung and Blood Institute of the NIH (R01HS025164); and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and the Collaboration on Research Integrity and Transparency at Yale. The other authors have nothing to disclose.

Comparative Effectiveness of Generic Latanoprost Versus Branded Prostaglandin Analogs for Primary Open Angle Glaucoma

ABSTRACTPurpose: The purpose of the study is to determine the comparative effectiveness of generic latanoprost (GL) to its branded (BL) counterpart and other brand-name prostaglandin analogs (bPGAs) in preventing the need for additional therapy in the treatment of primary open angle glaucoma (POAG).Methods: Retrospective cohort study using US commercial medical claims data. All new POAG patients from 2000 to 2015 who initiated treatment with either GL or BL were included. Exclusion occurred for having less than 2 years of time in the plan prior to diagnosis, previous use of glaucoma medications, or any diagnosis of glaucoma other than POAG at any time. Analyses compared GL to BL and also to those who received any branded PGA after 2011 (when the generic became available). Cox proportional hazard regression was used to assess the hazards of filling a prescription for a second IOP-lowering medication or having surgical intervention, individually and either outcome combined.Results: A total of 6317 and 4150 POAG patients were treated with GL and BL, respectively. After 2010, 6317 GL and 3703 brand-name prostaglandin analog (bPGA) POAG patients met criteria for inclusion. After adjustment, compared to BL, the GL conferred a reduced hazard of having a glaucoma procedure performed (hazard ratio [HR] = 0.72, 95% CI: 0.62–0.84, p < 0.001) and the combined outcome (HR = 0.90, 95% CI: 0.83–0.97, p = 0.006) but was not associated with having a second IOP medication (HR = 0.95, 95% CI: 0.87–1.03, p = 0.18). Compared to the bPGAs, however, GL conferred a reduced hazard in each comparison (second IOP medication HR = 0.87, 95% CI: 0.81–0.94, p < 0.001; surgery HR = 0.70, 95% CI: 0.61–0.81, p < 0.001; combined HR = 0.85, 95% CI: 0.79–0.92, p < 0.001). Sensitivity analyses confirmed these findings.Conclusions: GL was no less and possibly more effective in preventing the need for additional intervention than branded PGAs.

The physical properties of generic latanoprost ophthalmic solutions are not identical.

To compare various characteristics of Xalatan® and five generic latanoprost ophthalmic solutions. Drop size, volume, pH values, buffer capacity, viscosity, hardness of bottles and costs were determined. Drop sizes were measured in triplicates by micropipettes, and the number of drops counted in three separate bottles of each generic product was determined. pH values were measured in triplicates by a calibrated pH meter. Buffer capacity was exploited by titrating known quantities of strong base into 2.5ml of each brand and interpolated to neutral pH. Kinematic viscosity was determined by linear regression of timed gravity flow from a vertical syringe through a 21-G cannula. The hardness of the bottles was evaluated by gradually increasing tension on a hook placed around each bottle until a drop was expelled reading the tension on an attached spring scale. Drop sizes and the number of drops in the bottles varied significantly between the generic drugs. The control value of pH in the brand version (Xalatan® ) was markedly lower compared to the generic latanoprost products. Titration of Xalatan® to neutrality required substantially more NaOH compared to the generic latanoprost products. Finally, the viscosity revealed a significant variability between brands. Remarkable differences were found in bottle shapes, bottle hardness and costs of the latanoprost generics. Generic latanoprost eye drops should not be considered identical to the original brand version as regards to drop size, volumes, pH values, buffer capacity, viscosity, hardness of bottles and costs. It is likely that these issues affect compliance and intraocular pressure (IOP)-lowering effect. Therefore, re-evaluation of the requirements for introducing generic eye drops seems reasonable.

24-Hour Efficacy and Ocular Surface Health with Preservative-Free Tafluprost Alone and in Conjunction with Preservative-Free Dorzolamide/Timolol Fixed Combination in Open-Angle Glaucoma Patients Insufficiently Controlled with Preserved Latanoprost Monotherapy.

IntroductionThe aim of the present study was to evaluate the 24-h efficacy, tolerability, and ocular surface health with preservative-free (PF) tafluprost and a PF triple drug regimen comprising tafluprost and dorzolamide/timolol fixed combination (DTFC) in open-angle glaucoma patients who were insufficiently controlled with preserved branded or generic latanoprost monotherapy and who exhibited signs or symptoms of ocular surface disease (OSD).MethodsProspective, observer-masked, crossover, comparison. Eligible consecutive open-angle glaucoma patients were randomized to either PF tafluprost or the triple PF regimen for 3 months. They were then crossed over to the opposite therapy for another 3 months. At the end of the latanoprost run-in period and after each PF treatment period, patients underwent habitual 24-h intraocular pressure (IOP) monitoring with Goldmann tonometry in the sitting position (at 10:00, 14:00, 18:00, and 22:00) and Perkins tonometry in the supine position (at 02:00 and 06:00). Tolerability and selected ocular surface parameters were evaluated at baseline and the end of each treatment period.ResultsForty-three open-angle glaucoma patients completed the trial. Mean 24-h IOP on preserved latanoprost was 22.2 ± 3.9 mmHg. Compared with latanoprost monotherapy, PF tafluprost obtained a greater reduction in mean, peak, and fluctuation of 24-h IOP including the 02:00 and 06:00 time points (P < 0.05). With the exception of 24-h fluctuation, the triple PF regimen provided significantly lower IOP parameters than latanoprost or PF tafluprost (P < 0.001). Finally, PF tafluprost therapy displayed significantly improved tear film break-up times (6.7 vs 6.0 s), corneal staining (1.3 vs 2.2), and Schirmer I test results (9.1 vs 8.2 mm) compared with the preserved latanoprost baseline (all P < 0.01). The triple PF regimen demonstrated similar tear film break-up times (6.1 vs 6.0 s) and Schirmer I test results (8.2 vs 8.2 mm) to latanoprost, but revealed a significant improvement in the corneal stain test (1.7 vs 2.2; P < 0.001).ConclusionsIn this trial PF tafluprost therapy provided statistically greater 24-h efficacy and improved tolerability compared with preserved latanoprost. The combination of PF tafluprost and PF dorzolamide/timolol fixed combination was statistically and clinically more efficacious than both monotherapies and demonstrated similar ocular surface characteristics to preserved latanoprost monotherapy.Trial registrationClinicalTrials.gov (NCT02802137).FundingSanten.

Evaluation of physical properties and dose equivalency of generic versus branded latanoprost formulations.

The purpose of this study was to comparatively evaluate the pharmaceutical characteristics of various marketed generic formulations of prostaglandin analogue latanoprost in the Indian market. Three generics of latanoprost and one branded (Xalatan) formulation (five vials each) were obtained from authorized agents from the respective commercial sourcing having the same batch number. These formulations were coded, and the labels were removed. At a standardized room temperature of 25°C, the concentration, osmolarity, drop size, pH, and total drops per vial were determined for Xalatan and all the generics of latanoprost. The concentration of various brands varied between 50.49±0.36 and 58.90±0.52µg/ml as compared to the standard labeled concentration of 50µg/ml on the latanoprost vials. The concentration of drugs in individual drop varied from 1.30±0.05 to 1.78±0.04µg/drop. The volume of drug formulation per bottle varied from 2.4±0.12 to 2.6±0.09ml/bottle. The number of drops per bottle varied from minimum of 88.60±0.10 drops to maximum of 102.0±4.3 drops across all the formulations, while the drop size varied from 25.72±2.70 to 29.97±1.38µl. The osmolarity of 2/4 drugs was within 300mOs M (±10%). The specific gravity varied between 0.98±0.01 and 1.007±0.01, while pH was between 7.05±0.004 and 7.13±0.005. Two of the generic brands were outside the United States pharmacopoeia limits (±10%) for ophthalmic formulation, with concentration exceeding the limits by 3% (p=0.151) and 8% (p=0.008), respectively. This pilot study highlights that there are significant variations in the drug concentrations and physical properties of generic latanoprost formulations. Although none of the brands had concentrations below the recommended level, two of the brands had concentrations exceeding the limits by 3 and 8%, respectively.

Generic Drugs‐ are they as good as brand‐names?

PurposeThe aim of the present study was to investigate different characteristics of six Latanoprost generics.MethodsPrize, drop size and volume in each generic were determined. The hardness of each bottle was further evaluated using a fish weight and a hook. Finally, pH was measured and the buffer capacity evaluated by addition of NaOH.ResultsPrice, drop size and volume varied significantly between the brand version (xalatan) and the generic latanoprost products. Hence, drops sized were in the range 40–47 µl and the number of drops in each generic bottle varied between 95 and 111 drops. The embalages of each latanoprost product were different in both size and hardness. The control value of pH in the brand version (Xalatan) was 5.99 ± 0.01 (mean ± SD), whereas the generic latanoprost products had significantly higher values within the range 6.70–6.82. Hence, titration of 2.5 µl Xalatan to neutrality required 70.4 ± 0.4 nmol NaOH compared to the generic latanoprost products which required within the range 28.1–33.7 nmol NaOH.ConclusionsThe present study identifies differences among latanoprost generics such as different pH values and different buffer capacities. Moreover, the emballages varies significantly, thereby leading to critical variations in the handling of the generics. Finally, the number and size of drops in each generic were different, not to mention the prize variations between the brand version and the generics. Over all, generic eye drops should not be considered identical. Therefore, re‐evaluation of the requirements for introducing generic drugs seems reasonable.

Pharmacoeconomic aspects of glaucoma therapy with prostaglandin analogues in patients with signs of ocular surface disease

Treatment of glaucoma is prevalent in modern healthcare. The standard of care at this time in the majority of glaucoma patients is to be treated with prostaglandin analogues. The aim of the present study was to compare the cost-effectiveness and the effect on the daily quality of life of preservative-free tafluprost to benzalkonium chloride (BAK) preserved latanoprost ophthalmic solutions which are present on the Russian market. In the patients with signs of ocular surface disease. Material and methods. The cost calculation was carried out on the basis of the weighted average retail price in Moscow from March 2015. The research was carried out over a 1 yeartime period. At the assessment, we assumed that clinical efficacy of the compared drugs did not differ; but at the same time the absence of the negative impact of treatment on patients’ quality of life (QoL), assessed by COMTol questionnaire, was observed in 30 % of patients treated with BAK-preserved latanoprost and in 52 % of patients treated with preservative-free tafluprost. Results and discussion. The costs of glaucoma treatment with preservative-free tafluprost and with branded BAK-preserved latanoprost are now comparable. The cost per 1 patient without the negative impact of treatment on patients’ QoL for tafluprost (Taflotan®) was 42.6 % lower than that for branded latanoprost (Xalatan®), 72.7 % higher than that for the generic latanoprost Glaumax®, and 24.3 % higher than that for the generic latanoprost Latanomol™. The analysis of the results’ sensitivity to changes in the cost of drugs in real limits demonstrated their high reliability. When taking a decision on the reimbursement for prostaglandin analogues, one should be aware that generic latanoprost ophthalmic solutions may differ significantly from the branded drug both in physical and chemical properties as well as in clinical efficacy and safety. Conclusion. Preservative-free tafluprost and branded BAK-preserved latanoprost are characterized by comparable clinical efficacy whereas preservative-free tafluprost has better tolerability. At a comparable cost of treatment, preservative-free tafluprost has a higher cost-effectiveness. This allows recommending its inclusion in regional and federal programs for the treatment of glaucoma in patients with ocular surface disease signs.

Impact of the Introduction of Generic Latanoprost on Glaucoma Medication Adherence

To assess possible changes in medication adherence to prostaglandin analog (PGA) regimens among patients with open-angle glaucoma (OAG) after the initial introduction of generic PGAs. Longitudinal cohort analysis. Patients older than 40 years with OAG continuously enrolled in a nationwide managed-care network during 2009-2012 who used PGAs. Mean adherence rates were calculated for topical PGA use during the 18 months before the introduction of generic latanoprost (September 2009-February 2011) and the 18 months after generic latanoprost became available (July 2011-December 2012). The rates were compared between persons who continued to use brand-name PGAs once generic latanoprost became available and others who switched to generic latanoprost. Multivariable logistic regression identified variables associated with an improvement or worsening of adherence of ≥25%. Mean adherence rates and odds of 25% or more improved or worsened adherence (with 95% confidence intervals [CIs]). A total of 8427 patients met the study eligibility criteria. Compared with persons switching to generic latanoprost, patients who continued taking brand name PGAs were 28% less likely to have improved adherence (odds ratio [OR], 0.72; 95% CI, 0.55-0.94) and 39% more likely to have reduced adherence (OR, 1.39; 1.04-1.86) of ≥25%. Improved adherence after the generic drug's introduction was also associated with higher monthly medication copay in the pregeneric period (P = 0.02), lower copay after introduction of the generic drug (P < 0.0001), and black race (OR, 1.25; 95% CI, 1.04-1.50). Six-hundred twelve patients (7.3%) discontinued all antiglaucoma interventions when generic latanoprost became available. Given that cost can significantly deter adherence, switching patients to generic medications may help improve patients' drug-regimen adherence. A considerable number of patients discontinued glaucoma drug use altogether when generic latanoprost became available. Ophthalmologists should work with insurers and pharmacists to prevent such discontinuation of use as generic forms of other PGA agents become available.

Glaucoma prescribing trends in England 2000 to 2012.

In 2009, the National Institute for Clinical Excellence (NICE) published guidance on the treatment of ocular hypertension and glaucoma. The aim of the present study was to describe the impact this guidance had on glaucoma prescribing and to describe recent prescribing trends in England. Prescribing cost analysis data held by NHS Business Authority for the years 2000-2012 was analysed. The number of prescriptions dispensed increased by 67% from 4.76 million in 2000 to 7.96 million in 2012. Over the same time period, drug costs increased by 88% from £55.2 million to £103.7 million. Prescriptions for prostaglandin analogues increased fourfold, while there was a threefold decrease in the use of beta-blockers. The most commonly prescribed glaucoma medication was latanoprost. The introduction of generic latanoprost in 2012 more than halved the cost associated with this medication. NICE guidance appeared to have had no effect on the total number of prescriptions or the classes of medications prescribed. The introduction of the NICE guidelines did not change glaucoma prescribing practice, although it is not clear whether this represents non-adherence to the guidelines or whether the guidelines embodied pre-existing practice.

Comparison of intraocular pressure in glaucoma subjects treated with Xalatan® versus generic latanoprost

Comparison of intraocular pressure in glaucoma subjects treated with <scp>X</scp>alatan^® versus generic latanoprost

Comparative study of the IOP‐lowering effect of Xalatan vs generic latanoprost in normal subjects

AbstractPurpose To compare the intraocular pressure (IOP)‐lowering efficacy of Xalatan with the generic latanoprost (Latanoprost EG) in normal healthy subjects.Methods 20 normal subjects were recruited in this single‐center, randomized, prospective, open label, two‐period comparative study. At the baseline visit, subjects' baseline IOP was measured in both eyes at 8am in the morning. Subjects were then administered Xalatan in the right eye and Latanoprost EG in the left eye, both at 10pm, and IOP was controlled again the following morning at 8am. The student T‐test was used to assess the level of IOP decrease significance in both groups.Results The basline IOP in all the 20 subjects was: . The IOP decrease in the first group administered with Xalatan was 3.74 + 1.9 mmHg (26.11+ 11.3 mmHg). The IOP pressure at baseline and 10 hours after Xalatan administration were respectively 14.33 + 2.1 mmHg and 10.59 + 3.9 mmHg. In the second group, eyes administered with Latanoprost EG showed a slighter IOP decrease from baseline 2.54 + 1.33 mmHg (18.18 + 4.03 mmHg) The IOP at baseline and 10 hours after Latanoprost EG were respectively 14.01 + 2.37 mmHg and 11.45 + 2.39 mmHg. This difference was significative. (p &lt;0.05)Conclusion This study showed that the magnitude of IOP lowering in normal healthy subjects with Xalatan and Latanoprost EG is different, a higher IOP lowering efficacy of Xalatan compared to Latanoprost EG. This is important in Glaucoma patients especially when they are treated with different topical drops and for whom the maximum IOP decrease, achieving of the target IOP rang, maintenance of the remaining visual field and quality of life is crucial.

Are generic topical prostanoids the way forward in the care of glaucoma patients? – No

Given below are examples of clinical scenarios that I have encountered since starting my position as a consultant in March 2012. These scenarios aim to show that the use of cheaper generic preparations may not automatically lead to a cost-saving owing to a requirement for more outpatient appointments. Latanoprost is being cited as an example because of its widespread use. Scenario 1. A patient stops using the generic latanoprost, as the bottle looks different from their usual Xalatan, but does not tell anyone until they come for their follow-up appointment. Consequence: the patient's condition has been untreated for some weeks/months with an unquantifiable effect on disease progression. The outpatient appointment is wasted, as without applanation tonometry representing a treatment state the clinician cannot make a clinical decision as to whether the treatment is effective. There are cost implications of a clinic appointment to consider (which is charged to the commissioner, who also pays for the latanoprost) along with a wasted clinic slot that may have been better utilised. Scenario 2. A patient is unable to use the generic latanoprost because of not being to hold/squeeze the bottle properly, owing to the shape of the bottle being different from usual. Consequence: as above. Scenario 3. A patient is unable to use generic latanoprost, as the bottle does not fit the compliance aid issued with the original Xalatan. Consequence: as above. Scenario 4. A patient uses too much generic latanoprost because of the bottle releasing too much medication, and the medication runs out before the repeat prescription is due. Consequence: extra costs are incurred owing to (previously unnecessary) interim prescriptions. One patient was unable to obtain extra eye drops, as their family doctor refused to provide an interim prescription. Scenario 5. A patient receives a different generic product from 1 month to the next, thereby compounding scenarios 1–4 with the same results. Patients become confused with and wary of their family doctors/pharmacists as a result of changes in packaging. Scenario 6. Generic preparations do not all have the same storage instructions. Patients who are used to storing their Xalatan at room temperature—once opened—may be incorrectly assuming that this applies to all versions of generic latanoprost. Consequence: the patient may not have been treating their glaucoma with as much active agent as usual. Scenario 7. A previously well-controlled patient on Xalatan is now switched onto generic latanoprost and is no longer controlled despite good reported compliance, adequate supply, and a suitable storage environment. Possible reasons for this loss of control include a natural decline in the patient's condition, or the generic latanoprost is not as effective as Xalatan. It is impossible to tell the cause of the patient's loss of control, although I have experienced an improvement in patients' control following a switch to a branded alternative. Whether this is due to a compliance issue or a more efficacious product is impossible to ascertain. An extra outpatient appointment has to happen to make this otherwise unnecessary change, wasting resources. Scenario 8. Dispensing errors: I have now seen two patients who were both prescribed latanoprost on a repeat basis by their family physician; both were using fixed-combination generic latanoprost and timolol and both were experiencing side effects from the use of beta-blockers; both of these cases were due to dispensing errors made by different pharmacists in different pharmacies. Both drug boxes were clearly labelled with latanoprost only. See Figure 1. Figure 1 An example of a dispensing error.

A Comparison of Active Ingredients and Preservatives Between Brand Name and Generic Topical Glaucoma Medications Using Liquid Chromatography-Tandem Mass Spectrometry

Background: This work compares the concentration of active ingredients and preservatives in commonly used brand name versus generic glaucoma medications.Materials and Methods: Active ingredient and benzalkonium chloride (BAK) concentrations in brand name latanoprost and dorzolamide-timolol were each compared to two generic counterparts using liquid chromatography–mass spectrometry at baseline and after exposure to 25°C and 50°C for 30 days. Micro flow imaging was used to quantify particulate material greater than one micron in diameter.Results: Brand name formulations contained active ingredients and BAK in concentrations that were generally in agreement with their package inserts at baseline. The two generic formulations of latanoprost contained baseline levels of active ingredients that were 10% greater than their labeled value. Generic latanoprost formulations had significant loss of active ingredient concentration after exposure to 25°C and 50°C for 30 days. Both generic and brand name dorzolamide-timolol appeared relatively resistant to degradation. BAK concentrations remained stable at 25°C but decreased in some bottles at 50°C. Bottles of both generic medications had higher levels of particulate matter compared to brand name versions.Conclusions: Exposure to temperatures at the high end of the labeled value may lead to a significant decrease in concentration of active ingredients in generic formulations that could influence clinical efficacy. Re-evaluation of intraocular pressure lowering efficacy may be indicated in glaucoma patients switching from brand name to generic formulations.

A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan ® in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension

To compare the efficacy and tolerability of Xalatan with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). This was a single-center, randomized, open label, crossover, two period comparative study. At the baseline visit, subjects were randomized to two groups. Group A received Xalatan for weeks 1-12 followed by Latoprost for weeks 13-24. Group B received Latoprost for weeks 1-12 followed by Xalatan for weeks 13-24. 30 subjects were recruited, 12 in Group A and 18 in Group B. In subjects administered Xalatan, intraocular pressure (IOP) showed a greater decrease (P < 0.001) from 23.64 +/- 3.13 mmHg at baseline to 14.29 +/- 1.61 mmHg at week 12 (fall of 9.35 +/- 3.55 mmHg, 38.66% +/- 10.29) than that seen in the Latoprost group (22.74 +/- 2.47 mmHg to 16.98 +/- 2.49 mmHg, fall of 5.76 +/- 1.41 mmHg; 25.42% +/- 5.98). In period 2 when subjects were crossed over to Xalatan from Latoprost, there was a further fall from 16.98 +/- 2.49 mmHg to 16.09 +/- 1.49 at week 24 (fall of 0.89 +/- 1.59 mmHg; 4.3% +/- 8.76). However, when subjects were crossed over to Latoprost from Xalatan, the IOP rose from 14.29 +/- 1.61 mmHg to 15.36 +/- 1.71 mmHg at week 24 (8.86% +/- 17.76). There was no significant difference in incidence of conjunctival hyperemia or any other adverse events in both the groups. The magnitude of IOP lowering in patients with POAG and OH with Xalatan and Latoprost is different. In our study, the IOP lowering with Xalatan was higher than that with Latoprost.