Topical Prostaglandin Analogues Research Articles

Cystoid Macular Edema Related to Uncomplicated Cataract Surgery and Topical Prostaglandin Analogs: A Systematic Review of Randomized Controlled Trials

Cystoid Macular Edema Related to Uncomplicated Cataract Surgery and Topical Prostaglandin Analogs: A Systematic Review of Randomized Controlled Trials

Evaluation of the Effect of Topical Prostaglandin Analog Treatment on Orbital Structures in Open-Angle Glaucoma with Computed Tomography

Background/Objectives: This study aims to evaluate the computed tomography (CT) scans of glaucoma patients using prostaglandin analogs (PGA) in one eye, investigate findings associated with prostaglandin-associated periorbitopathy (PAP), and compare these findings with those of the contralateral eyes. Methods: Patients with open-angle glaucoma who had CT images of the orbital region taken for another reason at least one month after starting PGA treatment in one eye were included in the study. Enophthalmos measurements from thin-slice CT images, along with 3D volume measurements of orbital fat tissue, periorbital muscles, and the optic nerve, were performed. Ophthalmological examination findings and treatment information were collected. The values were compared with those of the contralateral eyes of the same patients not using PGA. Intraclass correlation coefficients (ICCs) were computed to evaluate measurement repeatability. Results: Forty patients were included in the study. Among them, 29 (72.5%) used latanoprost, 9 (22.5%) used bimatoprost, and 2 (5%) used travoprost. The mean enophthalmos values on the treated side (15.5 ± 2.0 mm) were lower than on the untreated side (16.1 ± 1.4 mm), but this difference was not statistically significant (p = 0.07). In 29 patients (72.5%), enophthalmos measurements were smaller on the treated side, with 7 patients (17.5%) showing a difference of 2 mm or more. No significant correlation was found between the duration of PGA use and enophthalmos measurements (p = 0.768 r = −0.048). Additionally, no significant differences were found in orbital fat volume, total extraocular muscle volume, and optic nerve volume (p > 0.05). ICC values demonstrated excellent reliability (ICC > 0.75) for all measurements. Conclusions: We did not find significant differences in enophthalmos measurements, orbital fat volume, total muscle volume, and optic nerve volume between the PGA-treated and untreated eyes.

Recurrence following ptosis repair surgery: a multivariate analysis of risk factors

ABSTRACT Purpose To identify and evaluate the risk factors for ptosis repair failure. Methods Retrospective, case-controlled study evaluating adult patients with ptosis who underwent ptosis surgery by external levator advancement/resection (ELR) or Müller muscle conjunctival resection (MMCR) with at least 3 months postoperative follow-up. Regression analyses were performed of ptosis repair outcomes comparing preoperative and perioperative risk factors for failure. Results A total of 240 patients (404 eyelids) met the inclusion criteria for the study. Surgical outcomes were measured categorically by success rate and measured quantitively over time using Kaplan–Meier survival analysis. Success was categorically achieved in 101/112 (90%) eyelids after MMCR and 231/292 (79%) eyelids after ELR (p = .0088). Success as measured over 5 years of follow-up was significantly better in eyelids following MMCR compared to ELR (p = .0469). In terms of surgical failure, the following variables were found to be predictive in order of decreasing risk: chronic topical prostaglandin use, chronic topical corticosteroid use, surgical approach, lower preoperative margin reflex distance 1, prior intraocular surgery, age, lower preoperative levator function, concomitant blepharoplasty, presence of a glaucoma filtering bleb, and female gender. Conclusions Ptosis repair surgery is a complex and challenging procedure. This study provides the largest comparative analysis of ELR versus MMCR to date with findings suggesting MMCR to be more a successful surgery than ELR. Topical prostaglandin analogue use appears to be the highest known risk factor for MMCR and ELR ptosis repair failure.

Does the Visual Field Improve After Initiation of Intraocular Pressure Lowering in the United Kingdom Glaucoma Treatment Study?

PurposeEvidence to support the hypothesis that visual field (VF) status can improve after initiation of intraocular pressure (IOP) reducing treatment is controversial. We take advantage of participant eligibility data from the United Kingdom Glaucoma Treatment Study (UKGTS) to test this hypothesis in newly diagnosed glaucomatous patients randomised to IOP lowering therapy or placebo. DesignMulticentre, randomised, triple-masked, placebo-controlled trial. ParticipantsNewly diagnosed open-angle glaucoma patients in the UKGTS with eligibility and baseline data (n = 202 and n = 205 participants from the treatment and placebo groups, respectively). MethodsUKGTS eligibility data, including two reliable VFs (Humphrey 24-2 SITA Standard) and IOP measurements were compared to UKGTS trial baseline data acquired after allocation to treatment (topical prostaglandin analog) or placebo eye drops. Mean change in VF mean deviation (MD) and proportion of eyes that improved MD by more than different thresholds were compared across this interval in the treatment and placebo groups. Secondary analyses included stratifying the groups by level of IOP, level of VF loss and age along with pointwise analyses including change in subsets of VF locations. Main outcome measureMean change in VF MD. ResultsMean (standard deviation [SD]) time between eligibility/baseline visits and reduction in IOP was 12 (3) weeks and 4.8 (4.2) and 1.0 (3.6) mmHg for the treated and placebo eyes, respectively. Mean (SD) change in MD was almost the same for the treated (-0.03 (1.45) dB) and placebo groups (+0.08 (1.72) dB) (P=0.47). Proportion of participants with an MD improvement of 1 dB or more were similar for both groups (P=0.25). No association was found between MD improvement and magnitude of IOP lowering. Stratifying data by IOP, level of VF loss and age did not reveal any differences between the treated and placebo groups and neither did any of the pointwise VF analyses. ConclusionInitial short-term VF changes in the treatment and placebo arms of UKGTS were the same. In these newly diagnosed patients (non-advanced glaucoma) we found no evidence to support the hypothesis that VF status improves after initial lowering of IOP by medical therapy.

Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension.

This study was conducted to analyze and compare the intraocular pressure (IOP) treatment effect of the slow-eluting (SE) travoprost intracameral implant to the IOP treatment effect of topical prostaglandin analog (PGA) monotherapy in a subgroup of subjects who were on pre-study PGA monotherapy prior to enrollment in the two pivotal phase 3 trials of the travoprost intracameral implant. A combined study population of 133 subjects from two phase 3 trials, who were on topical PGA monotherapy at screening, subsequently underwent a washout period from their topical PGA, and then were randomized and administered an SE travoprost intracameral implant. The subjects were analyzed for the IOP treatment effects of the pre-study topical PGA monotherapy and the in-study SE travoprost intracameral implant. Paired t-tests were used to compare the difference in screening minus post-washout baseline IOP versus month 3 minus post-washout baseline IOP. The IOP-lowering efficacy in eyes administered an SE travoprost intracameral implant was compared to the IOP lowering in the same eyes while on a topical PGA monotherapy prior to study entry. Pre-study topical PGA monotherapy and the SE travoprost intracameral implant demonstrated IOP treatment effects of -5.76mmHg and -7.07 mmHg, respectively. The IOP-lowering treatment effect was significantly greater by 1.31mmHg for the SE travoprost intracameral implant relative to pre-study PGA monotherapy (95% confidence interval: -2.01, -0.60; P = 0.0003). The SE travoprost intracameral implant demonstrated superior IOP-lowering treatment effect versus pre-study topical PGA monotherapy with a superiority margin that was both statistically significant and clinically meaningful. The greater IOP reduction from baseline while on the SE implant versus pre-study topical PGA monotherapy may be a reflection of the optimized adherence and continuous elution of PGA therapy into the anterior chamber achieved with the SE travoprost intracameral implant. ClinicalTrials.gov identifiers, NCT03519386 and NCT03868124.

Bimatoprost SR for Glaucoma Therapy Implanted at the Slit-Lamp in a Real-World Setting.

To characterize clinical outcomes following a single administration of bimatoprost SR in eyes with glaucoma in a real-world setting implanted at the slit-lamp. Tertiary care Glaucoma practice, Glaucoma Associates of Texas, Dallas, Texas. Retrospective interventional case series. Data were analyzed from consecutive patients receiving a single bimatoprost SR implant from the time of its approval to the time of data collection. All eyes were implanted at the slit-lamp. Eyes with less than 1 month of follow-up were excluded. The primary outcome was median time to next intraocular pressure (IOP)-lowering intervention. Mean IOP and medication use, and changes from baseline, were also assessed through 12 months of follow-up. Overall 129 eyes of 81 patients were analyzed. Following bimatoprost SR administration (replacing a topical prostaglandin analogue [PGA] in most eyes), the median survival time without any further IOP-lowering interventions was between 6-9 months. Mean IOP remained unchanged from baseline at month 1 (consistent with switch from topical to intracameral PGA therapy) and began to rise at month 3. At month 12, 40.5% of eyes (52 eyes) remained intervention-free, mean medication reduction was 0.5 medications per eye, and 27.8% of eyes (36 eyes) were medication-free. Adverse events were uncommon and most were transient and resolved with or without intervention. This real-world analysis of bimatoprost SR use for glaucoma therapy complements Phase 3 study findings and demonstrates that the implant can safely provide medication reduction through 6 months in most eyes and through 12 months in almost 40% of eyes.

Enhancing the hypotensive effect of latanoprost by combining synthetic phosphatidylcholine liposomes with hyaluronic acid and osmoprotective agents

The first line of glaucoma treatment focuses on reducing intraocular pressure (IOP) through the prescription of topical prostaglandin analogues, such as latanoprost (LAT). Topical ophthalmic medicines have low bioavailability due to their rapid elimination from the ocular surface. Nanotechnology offers innovative ways of enhancing the ocular bioavailability of antiglaucoma agents while reducing administration frequency. This study aims to combine LAT-loaded synthetic phosphatidylcholine liposomes with hyaluronic acid (0.2% w/v) and the osmoprotectants betaine (0.40% w/v) and leucine (0.90% w/v) (LAT-HA-LIP) to extend the hypotensive effect of LAT while protecting the ocular surface. LAT-HA-LIP was prepared as a mixture of 1,2-dioleoyl-sn-glycero-3-phosphocholine and 1,2-dimyristoyl-sn-glycero-3-phosphocholine, cholesterol and α-tocopherol acetate. LAT-HA-LIP exhibited high drug-loading capacity (104.52 ± 4.10%), unimodal vesicle sizes (195.14 ± 14.34 nm) and a zeta potential of -13.96 ± 0.78 mV. LAT-HA-LIP was isotonic (284.00 ± 1.41 mOsm L−1), had neutral pH (7.63 ± 0.01) and had suitable surface tension (44.07 ± 2.70 mN m−1) and viscosity (2.69 ± 0.15 mPa s−1) for topical ophthalmic administration. LAT-HA-LIP exhibited optimal in vitro tolerance in human corneal and conjunctival epithelial cells. No signs of ocular alteration or discomfort were observed when LAT-HA-LIP was instilled in albino male New Zealand rabbits. Hypotensive studies revealed that, after a single eye drop, the effect of LAT-HA-LIP lasted 24 h longer than that of a marketed formulation and that relative ocular bioavailability was almost three times higher (p < 0.001). These findings indicate the potential ocular protection and hypotensive effect LAT-HA-LIP offers in glaucoma treatment.Graphical abstract

One-year experience with latanoprostene bunod ophthalmic solution 0.024% in clinical practice: A retrospective observational study.

We evaluated the IOP-lowering efficacy and safety of latanoprostene bunod (LBN) ophthalmic solution 0.024% (Vyzulta®), the first topical nitric oxide-donating prostaglandin analog (PGA), in clinical practice. A retrospective medical chart review from July 2021 to July 2023 of patients with open-angle glaucoma receiving LBN with at least 1 year follow-up was conducted. All included patients received LBN 0.024% as a replacement for a PGA, with examinations at 1-, 3-, 6-and 12-months follow-up. Main outcome measures were IOP, retinal nerve fiber layer thickness, visual fields before/after LBN use and adverse effects. Subgroup analysis with glaucoma types and PGA use were performed for additional IOP reduction after LBN use. Among 78 included patients, 47 patients (81 eyes), 60% with open-angle glaucoma (OAG) remained on LBN throughout 12-month follow-up. Baseline IOP was 18.2±4.2 mm Hg, and Prostaglandin analog (PGA)-IOP was 14.4 ± 3.0 mm Hg (21% mean IOP reduction). After switched to LBN, mean additional IOP reduction was 1.0 mm Hg at month 1, and the greatest reduction was 1.6 mm Hg (8.8% additional mean IOP reduction) at month 12 (P<0.0001). Subgroup analysis (NTG, 73%) showed that mean additional IOP reduction at month 12 was 1.3±2.0 mm Hg in NTG group and 2.1±3.2 mm Hg in POAG group (7.7% vs. 8.7% additional IOP reduction rates, P = 0.23). Subgroup analysis of PGA use at month 12 was 1.8±2.3 mm Hg in tafluoprost group and 0.5±1.7 mm Hg in travoprost group (9.5% vs.2.6% additional IOP reduction rates, P = 0.02). Tolerable ocular adverse effects included irritation (n = 16, 19.8%), mild conjunctival hyperemia (n = 11, 13.6%), dark circles (n = 4, 4.9%) and blurred vision (n = 2, 2.5%). There were no significant visual field and retinal nerve fiber layer thickness changes after 12 months of treatment with LBN 0.024%. Although high intolerable adverse effects including conjunctival hyperemia and eye irritation happened in the first month, remaining sixty percent of patients exhibited statistically significant additional IOP reductions in the replacement of other PGAs during 12 months of clinical use of LBN 0.024%.

Effect of retrobulbar prostaglandin analog injection on orbital fat in rats.

Periorbital fat atrophy is a known side effect of topical prostaglandin analogs (PA). This side effect may have implications in the treatment of diseases like thyroid orbitopathy. In this in vivo study we aimed to evaluate the effects of retrobulbar injection of three different PAs on orbital fat. Eighteen adult male Wistar-albino rats were divided into three groups of six animals. 0.1ml of 0.03% bimatoprost, 0.005% latanoprost, or 0.005% travoprost was injected into the right orbits and saline was injected into the left orbits, as controls. Both orbits were exenterated after 3weeks. Histological cross-sections were analyzed using ImageJ image analysis software. Intraconal adipocyte density was calculated. There was no significant difference in the adipocyte density between the PA injected orbits and the control side in each of the three groups. When calculations from all three groups were analyzed together, again the difference in the adipocyte density between the PA injected orbits and the control side was not significant. No significant fat atrophy was noted in this rat model three weeks after retrobulbar injection of PAs. To evaluate retrobulbar injection of PA as a potential therapy for orbital diseases with fat proliferation, in vivo studies in different animal models, higher concentrations of PA, or longer follow-up duration are required.

Headache associated with travoprost

Background: Putative adverse effects of prostaglandin analogs in patients treated for glaucoma include periocular skin darkening, herpes simplex keratitis, cystoid macular edema, iritis, and headaches. Here, we report a case of migraine headache after a travoprost administration and discuss the role of prostaglandin analogs in migraine-like headaches.&#x0D; Case Presentation: A 70-year-old man visited the hospital complaining of pain, redness, and sensitivity to light for 1 week associated with gradual loss of vision in the right eye after cataract surgery, which had been performed 2 years prior. After the examination, the patient was diagnosed with pseudophakic bullous keratopathy and advised to undergo optical penetrating keratoplasty of the right eye. On postoperative day 3, his intraocular pressure (IOP) was 30 mmHg at 10:00 AM in the right eye. A single dose of 0.004% travoprost was instilled in the right eye on the same day. His IOP decreased to 16 mmHg at 2:00 PM. The next day, he presented with migraine-like headache that had started within 1 h after the instillation the previous night. Unremarkable neurological examination and neuroimaging suggested that travoprost had caused the migraine. Although the headache gradually resolved, it reappeared after the administration of other prostaglandins. Trabeculectomy was performed on the right side. The IOP was controlled, and the headache was resolved.&#x0D; Conclusions: This case indicates a potential causal relationship between topical prostaglandin analogs and migraine-like headaches, as evidenced by symptom resolution upon discontinuation. However, large-scale studies including control groups are required to prove a causal relationship between topical prostaglandin analog administrations and headache development.

Corneal Biomechanical Measures for Glaucoma: A Clinical Approach.

Over the last two decades, there has been growing interest in assessing corneal biomechanics in different diseases, such as keratoconus, glaucoma, and corneal disorders. Given the interaction and structural continuity between the cornea and sclera, evaluating corneal biomechanics may give us further insights into the pathogenesis, diagnosis, progression, and management of glaucoma. Therefore, some authorities have recommended baseline evaluations of corneal biomechanics in all glaucoma and glaucoma suspects patients. Currently, two devices (Ocular Response Analyzer and Corneal Visualization Schiempflug Technology) are commercially available for evaluating corneal biomechanics; however, each device reports different parameters, and there is a weak to moderate agreement between the reported parameters. Studies are further limited by the inclusion of glaucoma subjects taking topical prostaglandin analogues, which may alter corneal biomechanics and contribute to contradicting results, lack of proper stratification of patients, and misinterpretation of the results based on factors that are confounded by intraocular pressure changes. This review aims to summarize the recent evidence on corneal biomechanics in glaucoma patients and insights for future studies to address the current limitations of the literature studying corneal biomechanics.

Predictive Value of Dynamic Corneal Response Parameters Evaluated with Scheimpflug High-Speed Video (Corvis ST) on the Visual Field Progression in Prostaglandin Treated Ocular Hypertension and Open-Angle Glaucoma Patients.

The aim of this work is to compare the Corvis ST stress-strain index (SSI) and highest concavity (HC) parameters at baseline and 1month after initiating monotherapy with prostaglandin analogues (PGs) in eyes showing visual field (VF) progression or stability. In this prospective, single-center, observational study, newly diagnosed and treatment-naïve OAG patients were examined at baseline and 1month after beginning monotherapy with topical PGs monotherapy. Goldmann applanation tonometry pressure readings, Corneal Hysteresis (ORA-CH), and the Corvis ST measurements were obtained at both visits. VF progression (Humphrey) was evaluated based on data from 6 years of follow-up after the baseline visit. Stress-strain index (SSI) and HC parameters in progressing (P) and non-progressing (NP) eyes were the main outcome measures. Sixty-three eyes were analyzed; mean age was 64.63 ± 11.26years; 47 eyes were NP and 16 eyes were P according to the event analysis performed by the Humphrey device. There were no significant differences in IOP, CCT, or Corvis parameters between NP and P groups at baseline. Nevertheless, at 1 month, the SSI index was 1.60 ± 0.34 vs. 1.80 ± 0.34 (p = 0.003) in NP vs. P eyes, respectively. HC parameters were different between the groups at 1 month (p < 0.05) suggesting an increased scleral rigidity in the P group. There was no significant difference in IOP between groups at 1 month. The Corvis ST provides a corneal rigidity index (SSI) that seems to be related to VF progression when measured 1 month after initiating PGs monotherapy. Differences in HC parameters, indicative of increased scleral stiffness, are also evident at 1 month on latanoprost in the P eyes.

Pregnancy outcomes in the medical management of glaucoma: An international multicenter descriptive survey.

To determine if glaucoma medications are associated with pregnancy and/or postnatal complications. Multicenter descriptive survey. Subjects were female patients 18-45 years who were previously pregnant with a diagnosis of glaucoma or ocular hypertension prior to pregnancy. Chart review queried diagnosis, glaucoma severity, and race. Survey questions were asked for each pregnancy and queried pregnancy age, medications used, and pregnancy outcomes/complications. 114 pregnancies of 56 patients (mean 2.0 pregnancies per patient) were included. Three pregnancies with therapeutic abortion were excluded from further analysis. Mean age during pregnancy was 29.1 ± 5.7 years. Of the 111 pregnancies, 20 (18.0%) used no medications and 91 (82.0%) used at least one medication. Medications were topical carbonic anhydrase inhibitors (n = 45), beta-blockers (n = 55), alpha-agonists (n = 56), and prostaglandin analogues (n = 28). Outcomes were: preterm contractions/labour (6.3%), miscarriage (4.5%), stillbirth (4.5%), induction of labour (11.9%), emergency/unplanned caesarean delivery (13.9%), neonatal intensive care unit (NICU) stay (15.8%), congenital anomalies (8.1%), and low birth weight (10.9%). Fisher exact test assessed outcome associations with individual agents, use of any agent, and different number of agents. Alpha-agonist use was associated with NICU stay: 25.5% rate (p = 0.012) in alpha-agonist use. Most of the alpha-agonist use NICU stays occurred in pregnancies with third trimester use. All other associations were not statistically significant. The data from this survey suggest an overall favourable safety profile for topical glaucoma medications in pregnancy, but further investigation is needed. Caution should be employed regarding third trimester alpha-agonist use owing to association with NICU stay.

The efficacy of topical prostaglandin analogs for hair loss: A systematic review and meta-analysis.

Prostaglandin analogs have been found to have more versatile uses: treatment of open-angle glaucoma, high intraocular pressure, vitiligo, and other treatments. And prostaglandin analogs have been found to have an important role in the hair growth cycle. However, prostaglandin analogs have not been sufficiently studied for hair (including hair, eyelashes, and eyebrows) regeneration. In this study, a systematic review and meta-analysis of topical prostaglandin analogs on hair loss was performed. The purpose of this meta-analysis is to determine the efficacy and safety of topical prostaglandin analogs for treating hair loss. We searched PubMed, Embase, and Cochrane Library databases comprehensively. Data were pooled using Review Manager 5.4.1, and subgroup analyses were performed if necessary. There were six randomized controlled trials included in this meta-analysis. All studies compared prostaglandin analogs with placebo, and one trial consisted of two sets of data. The results showed that prostaglandin analogs could significantly improve the hair length and density (p < 0.001). As far as adverse events are concerned, there was no significant difference between the experimental group and the control group. In patients with hair loss, the topical prostaglandin analogs have better therapeutic efficacy and safety than placebo. However, the best dose and frequency of experimental treatment require further studies.

Improvement of Prostaglandin-Associated Periorbitopathy after Discontinuing Treatment.

To report that the periorbital changes induced by prostaglandin analogue (PGA) eye drops are partially reversible after discontinuing treatment. Nine patients with prostaglandin-associated periorbitopathy seen in a referral oculoplastic practice were included in this study, eight with unilateral glaucoma and one with bilateral open-angle glaucoma. All of them had been treated with topical PGA for at least one year, before the treatment was discontinued for cosmetic reasons. In all cases, there were evident periocular differences between the treated eye and the fellow eye, consisting mainly of deepening of the upper eyelid sulcus and eyelid fat pad reduction. One year after discontinuing the PGA eye drops, improvement of these features was observed. Clinicians and patients should be aware of the side effects of topical PGA therapy on periorbital tissues, and that these side effects can partially regress after discontinuation of the medication.

Effect of Topical Prostaglandin Analogue Therapy on Central Corneal Thickness: A Systematic Review.

To investigate whether prostaglandin analogue (PGA) eyedrops have a significant effect on central corneal thickness (CCT), we conducted a systematic search of literature published from 2000 to 2021. Among the studies conducted on topical PGA therapy in open-angle glaucoma or ocular hypertension patients over 18 years old, prospective studies with CCT change as an outcome were included. A single-arm meta-analysis was conducted to assess the overall effect on CCT, and subgroup analysis according to exposure time of PGA eyedrops was also performed. We counted the number of articles that reported on severe events (CCT reduction of 25 μm or more) and obtained their proportion. The methodological quality was assessed by the McHarm tool. Twenty-two reports of prospective studies were selected. The results of the single-arm meta-analysis showed very high heterogeneity. Still, in subgroup analysis, when PGA was used for more than 6 months, heterogeneity was low, and a significant decrease in CCT was observed. Severe events were reported in two reports and occurred in 3.8% to 14.8% of participants. PGA eyedrop use may cause a clinically significant CCT decrease, requiring CCT follow-up.

Glaucoma management in pregnancy, how safe glaucoma medication are?

AbstractPurpose: does the use of glaucoma medication during pregnancy can affect the outcome of pregnancy.Methods: Multicenter descriptive survey, for female patients age 18–45, who got pregnant while suffer from glaucoma. Charts reviewed for diagnosis, glaucoma severity, and race. Survey questions; they were asked for each pregnancy happened while they suffered from glaucoma about, pregnancy age, medications used, and patient‐reported pregnancy outcomes and complications. Main Outcome Measures: were patient‐reported and included pregnancy result; childbirth, miscarriage, stillbirth, therapeutic abortion (TAB)], method of delivery, occurrence of preterm labor, and other patient‐reported complications.Results: 114 pregnancies of 56 patients (mean 2.0 pregnancies per patient) were included. Three pregnancies with ended with TAB were excluded from further analysis. Mean age during pregnancy was 29.1 ± 5.7 years. Of the 111 pregnancies, 20 (18.0%) used no medications, 28 used one medication (25.2%), 38 used two (34.2%), 20 used three (18.0%), and 5 used four (4.5%). Medications used were topical carbonic anhydrase inhibitors (CAIs; n = 45), beta‐blockers (BB; n = 55), alpha‐agonists (AA; n = 56), and prostaglandin analogues (PGA; n = 28). Outcome rates in the overall cohort were: pre‐term contractions/labor in 6.3%, miscarriage (pregnancy loss ≤20 weeks) in 4.5%, stillbirth (pregnancy loss &gt;20 weeks) in 4.5%, induction of labor for vaginal delivery in 11.9%, emergency caesarean delivery in 13.9%, neonatal intensive care unit (NICU) stay in 15.8%, congenital anomalies in 8.1%, and low birth weight in 10.9%. Fisher exact test was performed to assess associations of complications with individual agents, use of any agent, and different number of agents. AA use was associated with NICU stay, with a rate of 25.5% in the AA group, and most of the AA use NICU stays occurred in pregnancies with third trimester AA use. All other associations were not statistically significant.Conclusions: This survey suggests an overall favourable safety profile for topical glaucoma medications in pregnancy. So, glaucoma medications can be used during pregnancy, but caution should be employed regarding third trimester AA use owing to an association with NICU stay.

Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from Ophthalmology Clinics in Italy.

IntroductionThe VISIONARY study examined the intraocular pressure (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) in a real-world setting. The country-level data reported herein comprise the largest and first observational study of PF tafluprost/timolol FC therapy in Italy.MethodsAn observational, multicenter, prospective study included adult Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) demonstrating insufficient response or poor tolerability with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Treatment was switched to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the absolute mean IOP change from baseline at Month 6. Exploratory and safety endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom severity and reporting of adverse events (AEs).ResultsOverall, 160 OAG/OHT patients were included. Mean ± standard deviation IOP was reduced from 19.6 ± 3.6 mmHg at baseline to 14.5 ± 2.6 mmHg at Month 6 (reduction of 5.1 ± 3.7 mmHg; 24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values for mean IOP change of ≥20%, ≥25%, ≥30% and ≥35%, respective Month 6 responder rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were significantly reduced in severity from baseline at Month 6. Two non-serious and mild AEs were reported during the study period, among which, one AE was treatment-related (eyelash growth). ConclusionItalian OAG and OHT patients demonstrated a significant IOP reduction from baseline at Week 4 that was maintained over a 6-month period following a switch from topical PGA or beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most ocular signs and symptoms was significantly reduced during the study period, and PF tafluprost/timolol FC was generally well tolerated.

Association between personality traits and experience of adverse periocular reactions to topical prostaglandin analogues

BackgroundAesthetically unappealing adverse periocular reactions to prostaglandin (PG) eye-drops are a major challenge in glaucoma treatment. This study analysed the personality traits of patients with glaucoma based on a five-factor...

Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment.

IntroductionThe VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy.MethodsA European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6.ResultsThe subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7 (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF-latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup (p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users (p < 0.001).ConclusionPF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively.Clinical Study NumberEuropean Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02166-6.