Ophthalmology and Therapy最新文献

{"title":"Is Multiwavelength Photobiomodulation Effective and Safe for Age-Related Macular Degeneration? A Systematic Review and Meta-Analysis.","authors":"Kai-Yang Chen, Hung Kuan Lee, Hoi-Chun Chan, Chi-Ming Chan","doi":"10.1007/s40123-025-01119-w","DOIUrl":"https://doi.org/10.1007/s40123-025-01119-w","url":null,"abstract":"<p><strong>Introduction: </strong>This systematic review and meta-analysis compares the complications and effects of photobiomodulation (PBM) therapy with sham treatment in patients with age-related macular degeneration (AMD). AMD is a leading cause of visual impairment in older adults, with current treatments primarily focusing on symptom management. PBM therapy is emerging as a potential intervention to improve clinical and anatomical outcomes in patients with AMD, necessitating a comparative analysis with sham treatment to determine its efficacy and safety.</p><p><strong>Methods: </strong>A systematic search was conducted across PubMed/Medline, Google Scholar and the Cochrane Library from inception to January 13, 2025. Randomised controlled trials (RCTs) meeting predefined inclusion criteria were selected. Meta-analysis employed random-effects models. The risk of bias in the included studies was assessed using Cochrane tools.</p><p><strong>Results: </strong>A total of six studies, comprising 360 patients and 477 eyes, focused on PBM for dry AMD. Five studies were eligible for meta-analysis. Best-corrected visual acuity (BCVA) showed no significant improvement with PBM (SMD - 0.30, 95% CI - 0.85 to 0.26, p = 0.30), with high heterogeneity (I² = 83%). Macular drusen volume also showed no significant change (SMD - 0.08, 95% CI - 0.52 to 0.37, p = 0.74), with moderate heterogeneity (I² = 48%). A single study reported no significant effect on geographic atrophy (SMD - 0.28, 95% CI - 1.26 to 0.71, p = 0.58). Central subfield thickness (SMD 0.11, 95% CI - 0.25 to 0.47, p = 0.58) and microperimetry (SMD - 0.02, 95% CI - 0.48 to 0.44, p = 0.94) also showed no significant changes. The adverse events analysis indicated a statistically significant increase in adverse events in the sham group within 6 months (RR 0.48, 95% CI 0.29-0.82, p = 0.007), while the overall effect on adverse events was non-significant (RR 1.04, 95% CI 0.51-2.12, p = 0.91, I² = 78%). Qualitative analysis suggested that PBM might enhance quality of life and clinical and anatomical outcomes compared to sham treatment.</p><p><strong>Conclusion: </strong>This meta-analysis suggests that, to date, there are no significant clinical benefits of PBM therapy for patients with AMD. Further long-term studies are needed to establish its clinical relevance and safety profile.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Varenicline Nasal Spray for the Treatment of Dry Eye Disease Following Corneal Collagen Crosslinking.","authors":"Tanner J Ferguson, David Durgan, Travis Whitt, Russell J Swan","doi":"10.1007/s40123-025-01118-x","DOIUrl":"https://doi.org/10.1007/s40123-025-01118-x","url":null,"abstract":"<p><strong>Introduction: </strong>To evaluate the safety and effectiveness of a varenicline solution nasal spray 0.03 mg (VNS) in reducing signs and symptoms of dry eye disease following corneal collagen cross-linking (CXL).</p><p><strong>Methods: </strong>Subjects undergoing CXL were randomized to VNS (study) or vehicle (control) twice daily and initiated treatment with VNS 28 days prior to the procedure with continued use for 28 days following the procedure. After starting treatment, subjects were seen on the day of surgery and postoperatively at days 2, 3, 4, 7 and 28. The primary outcome measure was the change in the National Eye Institute Visual Function Questionnaire (NEI-VFQ)-25, a dry eye questionnaire, from baseline to day 28. The second primary outcome measure was the mean area change of corneal epithelial healing following the CXL procedure. The secondary outcome measures for this study were the eye dryness score (EDS), degree of fluorescein staining and supplemental artificial tear usage.</p><p><strong>Results: </strong>Twelve subjects were enrolled in the study group and eight in the control group. At day 28, the NEI-VFQ-25 questionnaire demonstrated an improvement from baseline in the study group and a reduction in the control group, but the between-group comparison was not statistically significant (p > 0.05). There was a directional trend toward faster mean change of epithelial healing in the study group, but the difference was not statistically significant at any time point. There were four total adverse events, all of which were mild in nature and resolved without sequelae.</p><p><strong>Conclusions: </strong>VNS is an attractive treatment option for patients following CXL. Patients hoping to avoid punctal occlusion or additional use of topical medications following a procedure such as CXL may be well suited for a neurostimulator treatment option like VNS that spares the ocular surface.</p><p><strong>Trial registration: </strong>Registered with clinicaltrials.gov (NCT05136924).</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of a Deep Learning Model for Diabetic Retinopathy on Patients with Young-Onset Diabetes.","authors":"Antonio Tan-Torres, Pradeep A Praveen, Divleen Jeji, Arthur Brant, Xiang Yin, Lu Yang, Preeti Singh, Tayyeba Ali, Ilana Traynis, Dushyantsinh Jadeja, Rajroshan Sawhney, Dale R Webster, Naama Hammel, Yun Liu, Kasumi Widner, Sunny Virmani, Pradeep Venkatesh, Jonathan Krause, Nikhil Tandon","doi":"10.1007/s40123-025-01116-z","DOIUrl":"https://doi.org/10.1007/s40123-025-01116-z","url":null,"abstract":"<p><strong>Introduction: </strong>While many deep learning systems (DLSs) for diabetic retinopathy (DR) have been developed and validated on cohorts with an average age of 50s or older, fewer studies have examined younger individuals. This study aimed to understand DLS performance for younger individuals, who tend to display anatomic differences, such as prominent retinal sheen. This sheen can be mistaken for exudates or cotton wool spots, and potentially confound DLSs.</p><p><strong>Methods: </strong>This was a prospective cross-sectional cohort study in a \"Diabetes of young\" clinic in India, enrolling 321 individuals between ages 18 and 45 (98.8% with type 1 diabetes). Participants had fundus photographs taken and the photos were adjudicated by experienced graders to obtain reference DR grades. We defined a younger cohort (age 18-25) and an older cohort (age 26-45) and examined differences in DLS performance between the two cohorts. The main outcome measures were sensitivity and specificity for DR.</p><p><strong>Results: </strong>Eye-level sensitivity for moderate-or-worse DR was 97.6% [95% confidence interval (CI) 91.2, 98.2] for the younger cohort and 94.0% [88.8, 98.1] for the older cohort (p = 0.418 for difference). The specificity for moderate-or-worse DR significantly differed between the younger and older cohorts, 97.9% [95.9, 99.3] and 92.1% [87.6, 96.0], respectively (p = 0.008). Similar trends were observed for diabetic macular edema (DME); sensitivity was 79.0% [57.9, 93.6] for the younger cohort and 77.5% [60.8, 90.6] for the older cohort (p = 0.893), whereas specificity was 97.0% [94.5, 99.0] and 92.0% [88.2, 95.5] (p = 0.018). Retinal sheen presence (94% of images) was associated with DME presence (p < 0.0001). Image review suggested that sheen presence confounded reference DME status, increasing noise in the labels and depressing measured sensitivity. The gradability rate for both DR and DME was near-perfect (99% for both).</p><p><strong>Conclusion: </strong>DLS-based DR screening performed well in younger individuals aged 18-25, with comparable sensitivity and higher specificity compared to individuals aged 26-45. Sheen presence in this cohort made identification of DME difficult for graders and depressed measured DLS sensitivity; additional studies incorporating optical coherence tomography may improve accuracy of measuring DLS DME sensitivity.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bilateral In Vivo Confocal Microscopic Changes of the Corneal Subbasal Nerve Plexus in Patients with Acute Herpes Zoster Ophthalmicus.","authors":"Barbara Della Franca, Rémi Yaïci, Aleksandra Matuszewska-Iwanicka, Simona Nandrean, Ralf Gutzmer, Hans-Joachim Hettlich","doi":"10.1007/s40123-025-01112-3","DOIUrl":"https://doi.org/10.1007/s40123-025-01112-3","url":null,"abstract":"<p><strong>Introduction: </strong>Unilateral herpes zoster ophthalmicus (HZO) results in bilateral corneal denervation in patients with corneal involvement, which correlates with corneal sensation loss. The study aimed to analyze bilateral corneal nerve changes in patients with acute unilateral HZO and no keratitis compared with healthy controls.</p><p><strong>Methods: </strong>This was a prospective, single-center study. Using in vivo confocal microscopy (IVCM) and an automatized single image analysis software (ACCmetrics, University of Manchester, UK), seven corneal nerve parameters, including corneal nerve fiber density (CNFD; no/mm²), corneal nerve branch density (CNBD; no/mm²), corneal nerve fiber length (CNFL; mm/mm²), corneal nerve total branch density (CTBD; no/mm²), corneal nerve fiber area (CNFA; mm²/mm²), corneal nerve fiber width (CNFW; mm/mm²), and corneal nerve fiber fractal dimension (CFracDim) were analyzed. Additionally, central corneal sensitivity was measured.</p><p><strong>Results: </strong>Forty-six patients with HZO and 49 controls were recruited and compared. In the HZO group, ipsilateral and contralateral eyes presented a significant decrease (p < 0.001) in all seven IVCM parameters compared with controls: CNFD (13.25 ± 5.23 and 15.24 ± 4.70 vs. 23.54 ± 6.54), CNBD (14.67 ± 9.03 and 16.59 ± 7.98 vs. 31.72 ± 17.89), CNFL (8.42 ± 2.83 and 9.06 ± 2.69 vs. 13.08 ± 4.02), CTBD (27.11 ± 13.71 and 23.58 ± 12.69 vs. 46.88 ± 24.90), CNFA (0.0044 ± 0.002 and 0.0042 ± 0.001 vs. 0.0056 ± 0.002), CNFW (0.0213 ± 0.003 and 0.0221 ± 0.003 vs. 0.0222 ± 0.001) and CFracDim (1.39 ± 0.06 and 1.38 ± 0.06 vs. 1.45 ± 0.05). In the ipsilateral HZO eye group, a positive Hutchinson sign or a reduced corneal sensitivity was associated with more extensive corneal denervation. A significant negative correlation was found between patient age and CNFD (rho = - 0.312, p < 0.002), CNFL (rho = - 0.295, p = 0.004), and CFracDim (rho = - 0.284, p = 0.005).</p><p><strong>Conclusions: </strong>Unilateral HZO in patients without apparent keratitis leads to bilateral subbasal nerve plexus alteration in the early days after disease onset, especially in those with a positive Hutchinson sign. Early follow-up of patients with HZO and bilateral application of preservative-free artificial tears during the initial months of symptom onset may help reduce the risk of developing neurotrophic keratopathy (NTK).</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Minimal Gas Vitrectomy and As-Needed Positioning Duration for Idiopathic Macular Holes.","authors":"Yodpong Chantarasorn, Thanaporn Kritfuangfoo, Itsara Pokawattana, Kornwipa Hemarat, Chosita Tangjitwilaikul","doi":"10.1007/s40123-025-01114-1","DOIUrl":"https://doi.org/10.1007/s40123-025-01114-1","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to investigate postoperative outcomes of minimal gas vitrectomy (MGV) combined with a reduced period of gas-fovea contact in the management of idiopathic full-thickness macular holes (MHs).</p><p><strong>Methods: </strong>This retrospective cohort study included patients who underwent surgery for MHs with minimal hole diameters of 250-800 µm and categorized them into two groups: conventional fluid-gas exchange (FGX) (38 eyes) and MGV (28 eyes), with FGX replaced by a 1.0-1.2 mL injection of pure sulfur hexafluoride after internal limiting membrane peeling. Postoperatively, patients in the MGV group were kept in a face-down position, switching to face-forward or no positioning (pseudophakia) once MH closure was confirmed by optical coherence tomography, performed every few days during the first postoperative week. The maximum duration of face-down positioning was 5 days.</p><p><strong>Results: </strong>Most baseline characteristics were comparable between the two groups except for the proportion of combined cataract surgery and the use of non-expansile gas, which were higher in the FGX group. Prone positioning time in the MGV group was shorter than that in the control group (3.8 days vs. 11.9 days). Subfoveal fluid pocket was present in 73.0% and 5.2% of eyes in the MGV and FGX groups, respectively. Twenty-seven eyes (96.4%) in the MGV group showed MH closure within 3 months. At 12 months, compared to the FGX group, the MGV group exhibited less disruption of the ellipsoidal zone (28.5% vs. 57.8%), superior visual acuity (0.33 ± 0.18 vs. 0.54 ± 0.28), and comparable MH closure rates.</p><p><strong>Conclusion: </strong>In the treatment of medium-sized MHs, when compared to the FGX method, the use of a smaller volume of gas tamponade may be associated with earlier photoreceptor restoration. This method individualized prone positioning period without an immediate impact on central vision post surgery.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Geographic Atrophy Secondary to Subclinical Angioid Streaks in Age-Related Macular Degeneration: Progression of the Disease at 2-Year Follow-Up.","authors":"Riccardo Sacconi, Simone Marra, Elena Spada, Federico Beretta, Matteo Menna, Stefano Menecozzi, Francesco Bandello, Giuseppe Querques","doi":"10.1007/s40123-025-01111-4","DOIUrl":"https://doi.org/10.1007/s40123-025-01111-4","url":null,"abstract":"<p><strong>Introduction: </strong>The purpose of the study is to characterize the rate of progression of geographic atrophy (GA) areas in patients with age-related macular degeneration (AMD) with subclinical angioid streaks (AS), compared to patients with AMD without subclinical AS.</p><p><strong>Methods: </strong>This is a retrospective, longitudinal, case-control study. Among a cohort of patients with AMD, we selected patients with GA with subclinical AS and followed them for a 2-year follow-up. An age- and sex-matched control group with GA secondary to AMD without subclinical AS was selected. Demographics and differences in the GA progression between the two groups were analyzed.</p><p><strong>Results: </strong>Among 60 eyes of 60 patients affected by GA secondary to AMD, 20 eyes of 20 patients (mean age 82 ± 5 years old) were included in the subclinical AS group, whereas 40 eyes of 40 patients (mean age 79 ± 6 years old, p = 0.077) were in the control group. All 20 eyes of subclinical AS group showed reticular pseudodrusen at the baseline compared to 73% of patients without AS (p = 0.002). In the subclinical AS group, 90% of eyes showed peripapillary atrophy in comparison to 63% in the control group (p = 0.026). Subclinical AS eyes showed a significantly lower subfoveal choroidal thickness in comparison to the control group (124 ± 60 μm vs. 161 ± 84 μm, respectively, p = 0.043). At 2-year follow-up, the rate of progression was higher in the patients with subclinical AS; the yearly growth rate was 0.41 ± 0.17 mm/year after the square root transformation in the subclinical AS group, in comparison to 0.32 ± 0.14 mm/year in the control group (p = 0.017).</p><p><strong>Conclusions: </strong>Patients with subclinical AS showed a more aggressive phenotype of GA in comparison to AMD patients without subclinical AS, characterized by a higher rate of progression of GA areas during a 2-year follow-up.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143616711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In Vitro Activity of Bacteriophages Against Ocular Methicillin-resistant S. aureus Isolates Collected in the US.","authors":"Camille André, Mathieu Medina, Camille Kolenda, Leslie Blazière, Emilie Helluin, Gregory Resch, Paulo J M Bispo, Frédéric Laurent","doi":"10.1007/s40123-025-01113-2","DOIUrl":"https://doi.org/10.1007/s40123-025-01113-2","url":null,"abstract":"<p><strong>Introduction: </strong>Methicillin-resistant Staphylococcus aureus (MRSA) is a leading cause of sight-threatening infections in the US. These strains pose a significant challenge in managing ocular infections, as they frequently exhibit resistance to first-line empirical antibiotics. To assess the potential of bacteriophages as innovative topical therapies for treatment of recalcitrant ocular infections, we evaluated the in vitro antimicrobial activity of a set of anti-S. aureus phages against a collection of ocular MRSA clinical isolates collected in the US.</p><p><strong>Methods: </strong>The host range of six phages (V4SA2, V1SA9, V1SA12, V1SA19, V1SA20 and V1SA22) was assessed using the spot assay on a panel of 50 multidrug-resistant (MDR) ocular MRSA isolates selected to be representative of clones circulating in the US. Subsequently, liquid culture-based host range assay was performed for the three most active phages using different multiplicity of infection (MOI of 10^-2, 1 or 100 phages/bacteria).</p><p><strong>Results: </strong>In total, 90.0% of bacterial isolates were susceptible to at least one of the six phages. The spot host range assay showed that phages V1SA19, V1SA20 and V1SA22 had the broadest spectrum, being active against 86%, 84% and 82% of the isolates, respectively, including the MDR-MRSA CC5 and the community-associated CC8 lineages. A phage dose effect was observed across the liquid culture-based host range assay.</p><p><strong>Conclusion: </strong>Phages V1SA19, V1SA20 and V1SA22 exhibited high antimicrobial activity against ocular MRSA. Bacteriophages represent a promising anti-infective strategy in ophthalmology that could be explored for improved topical therapy of recalcitrant MRSA infections.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143616712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of an Eyelid Pressure Patch Concomitantly with a Decellularized Dehydrated Amniotic Membrane for Ocular Surface Disease Management.","authors":"Kyle Linsey","doi":"10.1007/s40123-025-01094-2","DOIUrl":"10.1007/s40123-025-01094-2","url":null,"abstract":"<p><strong>Introduction: </strong>Persistent corneal epithelial defects (PCEDs) occur when conditions like dry eye disease (DED), neurotrophic keratitis (NK), and limbal stem cell deficiency impair corneal healing, leading to risks of infection, scarring, or perforation. Decellularized, dehydrated pure amniotic membrane basement membrane (AMBM) supports healing by promoting cell adhesion, growth, and inflammation reduction. Eyelid pressure patching helps stabilize the AMBM, protects the cornea, and enhances its therapeutic effects.</p><p><strong>Methods: </strong>This retrospective study analyzed 144 eyes treated with either a single-layer or three-layer decellularized AMBM combined with a 24-h eyelid pressure patch.</p><p><strong>Results: </strong>Of the patients included, 90% received a single-layer AMBM and 10% a three-layer AMBM. In the single-layer group, 100% of cases showed complete healing and AMBM dissolution. In the three-layer group, 100% showed corneal staining improvement, but 20-30% of the AMBM remained undissolved. No patients reported experiencing pain, discomfort, or infection.</p><p><strong>Conclusions: </strong>Combining eyelid pressure patching with amniotic membrane treatment is a safe and effective approach for healing persistent corneal epithelial defects.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"573-584"},"PeriodicalIF":2.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11825428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Efficacy of Lotilaner Ophthalmic Solution (0.25%) in Treating Demodex Blepharitis: Pooled Analysis of Two Pivotal Trials.","authors":"Elizabeth Yeu, James D Paauw, Patrick Vollmer, Gregg J Berdy, William E Whitson, John Meyer, Blake Simmons, Jared D Peterson, Laura M Periman, Blair E Boehmer, Marc R Bloomenstein, Walter O Whitley, Cecelia Koetting, Kavita Dhamdhere, Sesha Neervannan, Joseph B Ciolino","doi":"10.1007/s40123-024-01089-5","DOIUrl":"10.1007/s40123-024-01089-5","url":null,"abstract":"<p><strong>Introduction: </strong>Lotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis.</p><p><strong>Methods: </strong>Pooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with ≤ 10 collarettes (grade 0 or 1 collarettes) at day 43.</p><p><strong>Results: </strong>Overall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to ≤ 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable.</p><p><strong>Conclusions: </strong>Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"555-571"},"PeriodicalIF":2.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11825414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Interval Progression and Adherence to Observe-and-Plan Regimen for Neovascular Age-Related Macular Degeneration Treated with Aflibercept 2 mg.","authors":"Leyla Turan, Andreas Arnold-Vangsted, Morten la Cour, Delila Hodzic-Hadzibegovic, Javad N Hajari, Oliver N Klefter, Miklos Schneider, Yousif Subhi","doi":"10.1007/s40123-025-01095-1","DOIUrl":"10.1007/s40123-025-01095-1","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment burden of anti-vascular endothelial growth factor (VEGF) therapy for neovascular age-related macular degeneration (AMD) can be reduced with the Observe-and-Plan (O&P) regimen, which allows for an individualized treatment while reducing the number of injections and assessment visits. In this study, we evaluate detailed characteristics of treatment interval adjustment through individual follow-ups and evaluate adherence to the O&P regimen in a real-world setting in one of the largest centers in Europe.</p><p><strong>Methods: </strong>This was a retrospective cohort study of treatment-naïve eyes with neovascular AMD that were treated with intravitreal aflibercept 2 mg in an O&P regimen who had persisting exudation after completion of loading dose. We evaluated decisions on adjustment of treatment intervals and adherence to the O&P regimen from a total of 5 follow-up visits. Data from visits and decision on treatment intervals were extracted from a treatment database.</p><p><strong>Results: </strong>A total of 561 eyes were eligible for this study. Treatment intervals gradually increased from a 4-weeks interval (loading dose) to a wide distribution of intervals from 4-weeks to 12-weeks, and at the 5th follow-up 24.9% were followed without any treatment. In total, 209 eyes (49.5%) at the 5th follow-up (of 422 eyes present at the 5th follow-up) adhered to the treatment algorithm.</p><p><strong>Conclusion: </strong>Aflibercept 2 mg in an O&P treatment regimen leads to a variety of treatment intervals, and some eyes may be overtreated. An important proportion of eyes deviate from the intended O&P treatment regimen. Our study contributes to understanding real-world implications of personalized treatment regimens.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"585-597"},"PeriodicalIF":2.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11825433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143080307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}