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1. Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study

Author

Oddone, F., Tanga, L., Kothy, P., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Zimina, M., Erichev, V., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Aguirrec, I. R., Lopez-Lopez, F., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Medina, J. G., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Kirwan, J., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Male, 030213 general clinical medicine, Intraocular pressure, genetic structures, Ocular hypertension, Timolol, Glaucoma, 0302 clinical medicine, Prostaglandins, Synthetic, Medicine, Pharmacology (medical), Prospective Studies, Open-angle glaucoma, media_common, Original Research, Aged, 80 and over, Fixed-dose combination, General Medicine, Middle Aged, Drug Combinations, Tolerability, 030220 oncology & carcinogenesis, Female, Glaucoma, Open-Angle, medicine.drug, medicine.medical_specialty, medicine.drug_class, Tonometry, Ocular, 03 medical and health sciences, Preservative-free topical medication, Ophthalmology, Humans, media_common.cataloged_instance, European union, Antihypertensive Agents, Intraocular Pressure, Aged, business.industry, Preservatives, Pharmaceutical, Prostaglandins F, Tafluprost, Correction, medicine.disease, eye diseases, sense organs, Prostaglandin analogue, business
Abstract

Introduction: A non-interventional, multicenter, European, prospective evaluation of the effectiveness, tolerability, and safety of a topical preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular hypertension (OHT) demonstrating insufficient response to topical beta-receptor blockers or prostaglandin analogue (PGA) monotherapy. Methods: Mean intraocular pressure (IOP) change from baseline was measured at study visits following a switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change at month 6. Change from baseline concerning ocular signs and symptoms was also explored. Results: Analyses included 577 patients (59.6% female). Mean age (SD) was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p < 0.0001 for all visits). At month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% cutoff values for mean IOP, respectively. Significant reductions were observed concerning corneal fluorescein staining (p < 0.0001), dry eye symptoms, irritation, itching, and foreign body sensation (p < 0.001 for each parameter). Conjunctival hyperemia was significantly reduced at all study visits (p < 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) were reported, one of which was serious (status asthmaticus). Most AEs were mild to moderate in severity, and the majority had resolved or were resolving at the end of the study period. Conclusion: In clinical practice, PF tafluprost/timolol FC provided statistically and clinically significant IOP reductions in patients with OAG and OHT insufficiently controlled on or intolerant to PGA or beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and was maintained over the 6-month study period. Key symptoms of ocular surface health improved. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number, EUPAS22204.

Published
2020

2. Correction to: 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 (Advances in Therapy, (2022), 39, 8, (3501-3521), 10.1007/s12325-022-02166-6)

Author

Oddone, F., Kirwan, J., Lopez-Lopez, F., Zimina, M., Fassari, C., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Erichev, V., Adbulaeva, E., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Rodriguez-Agirretxe, I., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Pharmacology (medical), General Medicine
Abstract

The authors would like to acknowledge missing data for all prior latanoprost users as a whole. The following sentence has been added to the manuscript (page 8, first paragraph): Mean (SD) reduction from baseline at Month 6 for users of all latanoprost formulations (preserved and PF) was 6.1 (4.25) mmHg (25.9%; p\0.0001). The authors have also prepared a table to summarise the change in intraocular pressure following a switch to the preservative-free tafluprost/timolol fixed-dose combination from all latanoprost formulations (preserved and preservative-free formulations). See Table 1 below.(Table Preseneted.) .The original article has been corrected.

Published
2022

3. 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

Author

Oddone, F., Kirwan, J., Lopez-Lopez, F., Zimina, M., Fassari, C., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Erichev, V., Adbulaeva, E., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Rodriguez-Agirretxe, I., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Subjects
Adult, Hyperemia, Tafluprost/timolol fixed-dose combination, Ocular hypertension, VISIONARY study, Travoprost, Preservative-free topical medication, Prostaglandin analogue monotherapy, Humans, Pharmacology (medical), Prospective Studies, Chronic, Open-angle glaucoma, Antihypertensive Agents, Intraocular Pressure, Real-world evidence, Prostaglandins A, Fatigue Syndrome, Chronic, Prostaglandins F, Glaucoma, General Medicine, Beta-blocker monotherapy, Fatigue Syndrome, Drug Combinations, Bimatoprost, Open-Angle, Timolol, Latanoprost, Glaucoma, Open-Angle
Abstract

Introduction: The 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. Methods: A 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. Results: The 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

Published
2022

4. Correction to: Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study (Advances in Therapy, (2020), 37, 4, (1436-1451), 10.1007/s12325-020-01239-8)

Author

Oddone, F., Tanga, L., Kothy, P., Hollo, G., Faschinger, C., Chen, E., Nemeth, G., Bator, G., Tsorbatzoglou, A., Acs, T., Ferencz, M., Sohajda, Z., Toth, J., Volner, V., Vogt, G., Biro, Z., Facsko, A., Nemes, J., Berta, A., Elek, I., Ng, E., Rossi, G., Rossetti, L., Vetrugno, M., Iester, M., Marchini, G., Scorcia, V., Staurenghi, G., Cagini, C., Salgarello, T., Bettin, P., Figus, M., Scuderi, G. L., De Cilla, S., Grundmane, I., Linavska, N., Volksone, L., Laganovska, G., Baumane, K., Lemij, H., Gundersen, K. G., Zimina, M., Erichev, V., Karlova, E., Zakharova, E., Panova, I., Malyugin, B., Aguirrec, I. R., Lopez-Lopez, F., Valladares, A. M., del Castillo, J. B., Gimenez, R., Vallejo, M. P., Garcia-Medina, J. J., Lopez, A. A., Torregrosa, S., Loscos, J., Kolko, M., Ansari, E., Broadway, D., Claridge, K., Ruben, S., Kirwan, J., Nita, A., Smith, M., Moosavi, A., King, A. J. W., and Kinsella, M.

Published
2020

8. A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension

Author

Topouzis, F., Melamed, S., Danesh-Meyer, H., Wells, A. P., Kozobolis, V. :., Wieland, H., Andrew, R., Wells, D., Kozobolis, V. P., Maskaleris, G., Detorakis, E., Anastasopoulos, E., Pappas, T., Kandarakis, A., Koutroumanos, J., Aspiotis, M., Pappa, C., Vaikoussis, E., Paschalidis, T., Bournas, P., Kazatzis, N., Goldberg, I., Graham, S., Healey, P., Rait, J. L., Bank, A., Healey, P. R., Crowston, J., Guzowski, M., Covar, R., Lee, A., Jen-Wano, Azar, Stadion, P., Lizin, F., De Groot, V., Schraepen, P., Reyntjens, B., Kestelyn-Stevens, A. -M., Witters, F., Teesalu, P., Kuus, I., Oll, M., Aamer, U., Alas, E., Pastak, M., Delbosc, B. Y. C., Gerstenberger, A., Jungmann, P., Hamacher, L. T., Hellmair, U., Bayer, A. U. M., Foerster, W., Christ, T., Reibaldi, A., Uva, M., Longo, A., Lombardo, D., Trimarchi, F., Milano, G., Clemente, A., Rossi, M. G., Scatassi, I., Montemurro, F., Grignolo, F. M., Brogliatti, B., Rolle, T., Favero, C., Giacosa, E., Fornero, A., Goldenfeld, M., Verbin, H., Vilner, Z., Knaan, R., Moroz, I., Geyer, O., Segev, E., Kurtz, S., Neudorfer, M., Shemesh, G., Zayit, S., Volksone, L., Karlsone, L., Laganovska, G., Baumane, K., Egite, I., Januleviciene, I., Kuzmiene, L., Riley, A., Bedggood, A., Long, H., Ashraff, N., Abrantes, P. A. L., Reina, M., Silva, J. P., Ilharco, J., Chew, P. T. K., Thean, L., Lim, B. A., Manuel, J., Loon, S. C., Tan, C., Yeong, S. M., Seah, S. K. L., Oen, F., Husain, R., Hoh, S. T., Tin, A., Sánchez, J. G., Feijoo, J. G., De La Casa, J. M. M., Gómez, A. C., López, F. M. H., Llorens, V. P., Júlvez, L. P., Martínez, M. L. G., Póvez, J. M. L., Arias-Puente, A., Carrasco, C., Del Carmen, M., García, Y., Alba, A., Gurdiel, E., Dorronzoro, E., Muniesa, M. J., D. -W., Lu, Clearkin, L. G., and Patwala, Y.

Subjects
travoprost/timolol, glaucoma, intraocular pressure
Published
2007

9. A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension

Author

Topouzis, F., Melamed, S., Danesh-Meyer, H., Wells, A. P., Kozobolis, V., Wieland, H., Andrew, R., Wells, D., Kozobolis, V. P., Maskaleris, G., Detorakis, E., Anastasopoulos, E., Pappas, T., Kandarakis, A., Koutroumanos, J., Aspiotis, M., Pappa, C., Vaikoussis, E., Paschalidis, T., Bournas, P., Kazatzis, N., Goldberg, I., Stuart Graham, Healey, P., Rait, J. L., Bank, A., Healey, P. R., Crowston, J., Guzowski, M., Covar, R., Lee, A., Jen-Wan, Azar, D., Stadion, P., Lizin, F., Groot, V., Schraepen, P., Reyntjens, B., Kestelyn-Stevens, A. -M, Witters, F., Teesalu, P., Kuus, I., Oll, M., Aamer, U., Alas, E., Pastak, M., Delbosc, B. Y. C., Gerstenberger, A., Jungmann, P., Hamacher, L. T., Hellmair, U., Bayer, A. U. M., Foerster, W., Christ, T., Reibaldi, A., Uva, M., Longo, A., Lombardo, D., Trimarchi, F., Milano, G., Clemente, A., Rossi, M. G., Scatassi, I., Montemurro, F., Grignolo, F. M., Brogliatti, B., Rolle, T., Favero, C., Giacosa, E., Fornero, A., Goldenfeld, M., Verbin, H., Vilner, Z., Knaan, R., Moroz, I., Geyer, O., Segev, E., Kurtz, S., Neudorfer, M., Shemesh, G., Zayit, S., Volksone, L., Karlsone, L., Laganovska, G., Baumane, K., Egite, I., Januleviciene, I., Kuzmiene, L., Riley, A., Bedggood, A., Long, H., Ashraff, N., Abrantes, P. A. L., Reina, M., Silva, J. P., Ilharco, J., Chew, P. T. K., Thean, L., Lim, B. A., Manuel, J., Loon, S. C., Tan, C., Yeong, S. M., Seah, S. K. L., Oen, F., Husain, R., Hoh, S. T., Tin, A., Sánchez, J. G., Feijoo, J. G., La Casa, J. M. M., Gómez, A. C., López, F. M. H., Llorens, V. P., Júlvez, L. P., Martínez, M. L. G., Póvez, J. M. L., Arias-Puente, A., Carrasco, C., Del Carmen, M., García, Y., Alba, A., Gurdiel, E., Dorronzoro, E., Muniesa, M. J., Lu, D. -W, Clearkin, L. G., and Patwala, Y.

10. Adjunctive use of tafluprost with timolol provides additive effects for reduction of intraocular pressure in patients with glaucoma

Author

Evgenii Alekseevich Egorov, Ropo, A., Erichev, V., Astakhov, Y., Alekseev, V., Takhchidi, K., Zhaboedov, G., Pasechnikova, N., Kaljurand, K., Palumaa, K., Lagnovska, G., Eugeny, E. E. A., Staritskaya, T. V., Evgen Evna, E. T., Borisovna, R. T., Sheremetyeva, S. S., Oganezova, J. G., Petrovich, E. V., Vagizona, Y. L., Sergueevich, A. Y., Alekseevna, D. G., Borisovna, L. A., Kasimovna, A. L., Victorovich, P. A., Levko, M., Martynova, E., Kolotov, A., Mironova, E. M., Proshina, O. I., Kozlova, E. E., Sochinskaya, V. K., Grishina, T. S., Zhaboedov, G. D., Petrenko, O. V., Tymoshenkova, O. V., Vitovska, O. P., Kurilina, O. I., Parkhomenko, O. G., Pasechnokova, N. V., Korol, A. R., Klyuev, G. O., Romodanova, K. S., Nevska, A., Padanevych, E., Pastak, M., Seljagina, N., Somma, K., Laganovska, G., and Baumane, K.

11. Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-related Macular Degeneration: A Phase 3 Randomized Trial.

Author

Hamouz J, Nowosielska A, Święch-Zubilewicz A, Abengoechea S, Baumane K, Vajas A, Siewierska M, Veselovsky M, Veith M, Kerényi Á, Mange S, Baidya K, Laganovska G, Jürgens I, Papp A, Gosai J, Štefanickova J, Han M, Fryczkowski P, Zalewski D, Wang J, and Wei W

Abstract

Objective: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis®, in patients with neovascular age-related macular degeneration (nAMD)., Design: This was a multi-center, double-blinded, randomized controlled phase 3 trial., Subjects, Participants, and Controls: Treatment-naïve patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab., Methods, Intervention, or Testing: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every four weeks for 48 weeks., Main Outcome Measures: The primary endpoint was change in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 compared to baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49., Results: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n=308) and the reference ranibizumab group (n=308). The mean improvement of BCVA was +6.3±9.13 ETDRS letters in the QL1205 group and +7.3±8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI) [-2.23, 0.13] and 95% CI [-2.46, 0.36] of the difference between the two treatment groups (P=0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups., Conclusions: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD., (Copyright © 2024. Published by Elsevier Inc.)

Published
2024
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12. Aflibercept Biosimilar MYL-1701P vs Reference Aflibercept in Diabetic Macular Edema: The INSIGHT Randomized Clinical Trial.

Author

Bressler SB, Barve A, Ganapathi PC, Beckmann K, Apte RS, Marcus DM, Baumane K, Agarwal S, Oleksy P, Reichstein DA, Patel SS, Ernest J, Dégi R, Gupta V, Kishino G, Kamei M, and Loganathan S

Subjects
Humans, Male, Double-Blind Method, Female, Middle Aged, Treatment Outcome, Aged, Vascular Endothelial Growth Factor A antagonists & inhibitors, Tomography, Optical Coherence, Recombinant Fusion Proteins therapeutic use, Recombinant Fusion Proteins administration & dosage, Receptors, Vascular Endothelial Growth Factor administration & dosage, Diabetic Retinopathy drug therapy, Diabetic Retinopathy diagnosis, Diabetic Retinopathy physiopathology, Macular Edema drug therapy, Macular Edema physiopathology, Macular Edema diagnosis, Intravitreal Injections, Visual Acuity physiology, Angiogenesis Inhibitors administration & dosage, Angiogenesis Inhibitors therapeutic use, Angiogenesis Inhibitors adverse effects, Biosimilar Pharmaceuticals therapeutic use, Biosimilar Pharmaceuticals adverse effects
Abstract

Importance: Biosimilars may be lower-cost alternatives to originator biologic products, potentially offering expanded access or reduced economic burden, but have not been evaluated with aflibercept in diabetic macular edema (DME)., Objective: To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME., Design, Setting, and Participants: This was a double-masked, randomized clinical trial that included participants at 77 centers across the US, Europe, Japan, and India. Included in the analysis were individuals 18 years and older with type 1 or type 2 diabetes with central DME and best-corrected visual acuity (BCVA) letter score of 73 to 38 in the study eye using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Study data were analyzed from October to December 2021., Interventions: Formulations of MYL-1701P (0.5-mg vial) or reference aflibercept every 4 weeks for 5 consecutive intravitreal injections, followed by every 8 weeks through week 52., Main Outcomes and Measures: The primary outcome was the adjusted difference in least squares mean (SE) change from baseline BCVA letter score at week 8 with an equivalence margin of -3 to +3 letters. Secondary outcomes included change in central subfield thickness (CST), BCVA, number of injections over 52 weeks, incidence of adverse events (AEs), and antidrug antibodies (ADAs)., Results: A total of 355 participants (mean [SD] age, 62.2 [9.2] years; 216 male [60.8%]) were randomized to MYL-1701P (179 participants [50.4%]) and aflibercept (176 participants [49.6%]). At week 8, mean (SE) change in BCVA was 6.60 (0.55) letters vs 6.56 (0.55) letters in the MYL-1701P vs aflibercept groups. The adjusted mean difference of 0.04 letters (90% CI, -1.16 to 1.24 letters) met the primary outcome. At week 8, mean (SE) change in CST was -112 (7) μm vs -124 (7) μm in the MYL-1701P vs aflibercept groups (adjusted mean difference, 12 μm; 90% CI, -3 to 26 μm). The incidence of treatment-emergent AEs in the MYL-1701P and aflibercept arms were ocular (30.9% [55 of 178] vs 29.5% [52 of 176]), serious ocular (0.6% [1 of 178] vs 1.1% [2 of 176]), nonocular (65.2% [116 of 178] vs 65.3% [115 of 176]), and serious nonocular (16.9% [30 of 178] vs 11.9% [21 of 176]). The mean (SD) total number of injections was 8.4 (2.1) vs 8.7 (1.8) in the MYL-1701P vs aflibercept groups. The incidence of treatment-induced or treatment-boosted ADAs was 2.8% (5 of 177) vs 5.7% (10 of 176) in the MYL-1701P vs aflibercept arms., Conclusions and Relevance: MYL-1701P demonstrated clinical equivalence in regard to efficacy, with comparable safety and immunogenicity, to reference aflibercept. These findings support use of MLY-1701P as an alternative to reference aflibercept., Trial Registration: ClinicalTrials.gov Identifier: NCT03610646.

Published
2024
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13. DNA Methylation Profiles of PSMA6 , PSMB5 , KEAP1 , and HIF1A Genes in Patients with Type 1 Diabetes and Diabetic Retinopathy.

Author

Svikle Z, Paramonova N, Siliņš E, Pahirko L, Zariņa L, Baumane K, Petrovski G, and Sokolovska J

Abstract

We explored differences in the DNA methylation statuses of PSMA6 , PSMB5 , HIF1A , and KEAP1 gene promoter regions in patients with type 1 diabetes and different diabetic retinopathy (DR) stages. Study subjects included individuals with no DR (NDR, n = 41), those with non-proliferative DR (NPDR, n = 27), and individuals with proliferative DR or those who underwent laser photocoagulation (PDR/LPC, n = 46). DNA methylation was determined by Zymo OneStep qMethyl technique. The methylation of PSMA6 (NDR 5.9 (3.9-8.7) %, NPDR 4.5 (3.8-5.7) %, PDR/LPC 6.6 (4.7-10.7) %, p = 0.003) and PSMB5 (NDR 2.2 (1.9-3.7) %, NPDR 2.2 (1.9-3.0) %, PDR/LPC 3.2 (2.5-7.1) %, p < 0.01) differed across the groups. Consistent correlations were observed between the methylation levels of HIF1A and PSMA6 in all study groups. DNA methylation levels of PSMA6 , PSMB5 , and HIF1A genes were positively correlated with the duration of diabetes, HbA1c, and albuminuria in certain study groups. Univariate regression models revealed a significant association between the methylation level z-scores of PSMA6 , PSMB5 , and HIF1A and severe DR ( PSMA6 : OR = 1.96 (1.15; 3.33), p = 0.013; PSMB5 : OR = 1.90 (1.14; 3.16), p = 0.013; HIF1A : OR = 3.19 (1.26; 8.06), p = 0.014). PSMB5 remained significantly associated with DR in multivariate analysis. Our findings suggest significant associations between the severity of DR and the DNA methylation levels of the genes PSMA6 , PSMB5 , and HIF1A , but not KEAP1 gene.

Published
2024
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14. Ubiquitin-proteasome system in diabetic retinopathy.

Author

Svikle Z, Peterfelde B, Sjakste N, Baumane K, Verkauskiene R, Jeng CJ, and Sokolovska J

Subjects
Animals, Humans, Cytoplasm metabolism, Proteasome Endopeptidase Complex metabolism, Ubiquitin metabolism, Diabetes Mellitus, Experimental drug therapy, Diabetic Retinopathy etiology
Abstract

Diabetic retinopathy (DR) is the most common complication of diabetes, being the most prevalent reason for blindness among the working-age population in the developed world. Despite constant improvement of understanding of the pathogenesis of DR, identification of novel biomarkers of DR is needed for improvement of patient risk stratification and development of novel prevention and therapeutic approaches. The ubiquitin-proteasome system (UPS) is the primary protein quality control system responsible for recognizing and degrading of damaged proteins. This review aims to summarize literature data on modifications of UPS in diabetes and DR. First, we briefly review the structure and functions of UPS in physiological conditions. We then describe how UPS is involved in the development and progression of diabetes and touch upon the association of UPS genetic factors with diabetes and its complications. Further, we focused on the effect of diabetes-induced hyperglycemia, oxidative stress and hypoxia on UPS functioning, with examples of studies on DR. In other sections, we discussed the association of several other mechanisms of DR (endoplasmic reticulum stress, neurodegeneration etc ) with UPS modifications. Finally, UPS-affecting drugs and remedies are reviewed. This review highlights UPS as a promising target for the development of therapies for DR prevention and treatment and identifies gaps in existing knowledge and possible future study directions., Competing Interests: Zane Svikle, Beate Peterfelde, Nikolajs Sjakste, Kristine Baumane, Rasa Verkauskiene, and Chi-Juei Jeng report no conflicts of interest. Jelizaveta Sokolovska reports lecture fees and educational grants from Sandoz, Sanofi, MSD, NovoNordisc, AstraZeneca, Grindex outside the submitted work. Nikolajs Sjakste is an Academic Editor for PeerJ., (© 2022 Svikle et al.)

Published
2022
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15. Telomere Lengths and Serum Proteasome Concentrations in Patients with Type 1 Diabetes and Different Severities of Diabetic Retinopathy in Latvia and Lithuania.

Author

Svikle Z, Pahirko L, Zariņa L, Baumane K, Kardonaite D, Radzeviciene L, Daugintyte-Petrusiene L, Balciuniene VJ, Verkauskiene R, Tiščuka A, Rovite V, Sjakste N, and Sokolovska J

Abstract

The aim of the study was to compare telomere lengths and circulating proteasome concentrations in patients with different stages of diabetic retinopathy and type 1 diabetes in Latvia and Lithuania. Methods. Patients with no diabetic retinopathy and with non-proliferative diabetic retinopathy were included in the NDR/NPDR group (n = 187). Patients with proliferative diabetic retinopathy and status post laser-photocoagulation were included int the PDR/LPC group (n = 119). Telomeres were evaluated by real-time quantitative polymerase chain reaction. Proteasome concentration was measured by ELISA. Results. Telomeres were longer in PDR/LPC (ΔCT 0.21 (0.12−0.28)) vs. NDR/NPDR (ΔCT 0.18 (0.1−0.28)), p = 0.036. In NDR/NPDR, telomeres were correlated negatively with age (R = −0.17, p = 0.019), BMI (R = −0.21, p = 0.004), waist/hip ratio (R = −0.21, p = 0.005), total cholesterol (R = −0.18, p = 0.021), and low-density cholesterol (R = −0.20, p = 0.010), and positively with estimated glomerular filtration rate (eGFR) (R = 0.28, p < 0.001). None of the above correlations were observed in PRD/LPC. Proteasome concentrations were lower in PDR/LPC (130 (90−210) ng/mL) vs. NDR/NPDR (150 (100−240) ng/mL), p = 0.024. This correlated negatively with eGFR (R = −0.17, p = 0.025) in the NDR/NPDR group and positively with age (R = 0.23, p = 0.014) and systolic blood pressure (R = 0.20, p = 0.032) in the PRD/LPC group. Telomere lengths did not correlate with proteasome concentrations. Conclusion. Longer telomeres and lower circulating proteasome concentrations are observed in patients with type 1 diabetes and advanced diabetic retinopathy.

Published
2022
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16. The Epidemiological and Clinical Findings from the Latvian Registry of Primary Congenital Glaucoma and Evaluation of Prognostic Factors.

Author

Elksne E, Baumane K, Ozolins A, and Valeina S

Subjects
Administration, Ophthalmic, Amblyopia physiopathology, Astigmatism physiopathology, Cohort Studies, Delayed Diagnosis, Female, Glaucoma epidemiology, Glaucoma physiopathology, Glaucoma therapy, Humans, Infant, Infant, Newborn, Intraocular Pressure physiology, Latvia epidemiology, Male, Prognosis, Registries, Retrospective Studies, Sex Distribution, Treatment Outcome, Visual Acuity, Axial Length, Eye physiopathology, Glaucoma congenital, Trabeculectomy
Abstract

Background and objectives : primary congenital glaucoma (PCG) is a rare, potentially blinding disease that affects children worldwide. The aim of the study was to describe the epidemiological and clinical characteristics, outcomes for newly diagnosed patients with PCG, as well as evaluate the prognostic factors that are related to the outcomes. Materials and Methods : a retrospective cohort study was conducted at a tertiary referral centre among patients diagnosed with PCG. Evaluation of the clinical data was performed preoperatively at three, six, and 12 months after the surgery and at the last follow-up. Results : during the 15 years of follow-ups, 24 eyes of 18 patients were diagnosed with PCG. Unilateral and bilateral PCG constituted 50% of cases each. A slight male predominance was observed (55.6% vs. 44.4%), with a relative risk of 1.3. The incidence of PCG was 1:19,033 live births. The mean age of the patients at the time of diagnosis was 10.1 ± 10.0 months, with a diagnostic delay of 2.0 ± 1.9 months. Furthermore, 75% of patients indicated an enlargement of an eyeball, followed by excessive tearing (58.3%) and corneal opacity (41.7%). After 85.9 ± 51.2 months, the mean intraocular pressure (IOP) value was 14.6 ± 4.9 mmHg. Surgical treatment provided sufficient IOP control in 75% of PCG cases at the last follow-up visit. The only prognostic factor that was related to the outcome of IOP control that was statistically significant was axial length at the time of diagnosis. Conclusions : the incidence of PCG in Latvia was 5.3 patients per 100,000 live births. PCG was more common among males than females with a relative risk of 1.3. The enlargement of an eyeball was the leading clinical sign.

Published
2021
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17. Association of NT-proANP Level in Plasma and Humor Aqueous with Primary Open-Angle Glaucoma.

Author

Baumane K, Ranka R, and Laganovska G

Subjects
Aged, Biomarkers metabolism, Cataract metabolism, Cataract Extraction, Enzyme-Linked Immunosorbent Assay, Female, Glaucoma, Open-Angle physiopathology, Glaucoma, Open-Angle surgery, Humans, Male, Middle Aged, Trabeculectomy, Aqueous Humor metabolism, Atrial Natriuretic Factor metabolism, Glaucoma, Open-Angle metabolism, Intraocular Pressure
Abstract

Purpose: The aim of this study is to determine differences in the levels of NT-proANP in the plasma and aqueous humor of glaucoma and cataract patients and to evaluate whether any relationships are present., Methods: The study group consisted of 58 patients with primary-open glaucoma (POAG) undergoing trabeculectomy surgery. The control group was comprised of 32 age-matched cataract patients. The concentration of the N-terminal fragment of the proatrial natriuretic peptide (NT-proANP, 1-98) in the aqueous humor and blood plasma samples was measured using an immunochemical method (ELISA)., Results: The plasma NT-proANP concentration was significantly increased in patients with POAG compared to that in the control group (7.00 vs. 4.65 nmol/L, P = 0.0054). Similarly, the NT-proANP concentration in the aqueous humor was significantly higher in the POAG patients (0.47 vs. 0.09 nmol/L, P = 0.0112). However, there was no correlation between the NT-proANP values in the aqueous humor and the plasma of the POAG patients, as well as between the NT-proANP values in the aqueous humor and the intraocular pressure., Conclusions: We identified an association between the levels of NT-proANP in the plasma and the aqueous humor with POAG. Our data support the idea of the involvement of NP system in the development of POAG and highlight ANP as a possible biomarker of glaucoma.

Published
2017
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18. Point mutations associated with Leber hereditary optic neuropathy in a Latvian population.

Author

Aitullina A, Baumane K, Zalite S, Ranka R, Zole E, Pole I, Sepetiene S, Laganovska G, Baumanis V, and Pliss L

Subjects
Adult, Female, Haplotypes, Humans, Latvia, Male, Middle Aged, Mitochondria pathology, Optic Atrophy, Hereditary, Leber diagnosis, Optic Atrophy, Hereditary, Leber ethnology, Optic Atrophy, Hereditary, Leber pathology, Pedigree, Polymorphism, Genetic, Sequence Analysis, DNA, White People, DNA, Mitochondrial genetics, Mitochondria genetics, Optic Atrophy, Hereditary, Leber genetics, Point Mutation
Abstract

Purpose: To study mutations associated with Leber hereditary optic neuropathy (LHON) in patients suspected of having this mitochondrial disorder in a Latvian population. Additional aims were to determine the heteroplasmy status of all non-synonymous polymorphisms identified in the current study and to identify the mitochondrial haplogroups of the studied participants because these factors may contribute to the manifestation of LHON., Methods: Twelve patients, including patients in two families, were enrolled in the current study. LHON was suspected based on the findings of ophthalmologic examinations. In clinically affected individuals, the presence of all previously reported LHON-associated mutations was assessed with sequencing analysis. Additionally, the SURVEYOR endonuclease assay was used to detect heteroplasmy. The mitochondrial haplogroups were identified with restriction analysis and the sequencing of hypervariable segment 1., Results: In one family (mother and son), there was one primary LHON-associated mutation, G11778A. In addition, one rare previously reported LHON-associated polymorphism, A13637G, was detected in two unrelated patients. A non-synonymous polymorphism at T6253C was found in one individual. This mutation was reported in the background of the 3460 mutation among LHON patients in a Chinese population. No non-synonymous point mutations in mitochondrial DNA were found in five of the study participants., Conclusions: Molecular analysis of 12 patients with suspected LHON confirmed the diagnosis in four patients and allowed the use of appropriate prophylactic measures and treatment. Further investigations and additional studies of different populations are necessary to confirm the role of the non-synonymous polymorphisms A13637G and T6253C in the manifestation of LHON and the associations of these polymorphisms with mitochondrial haplogroups and heteroplasmy.

Published
2013

19. A multicenter, double-blind, parallel group, placebo-controlled clinical study to examine the safety and efficacy of T-Clair SPHP700-3 in the management of mild to moderate dry eye in adults.

Author

Villani E, Laganovska G, Viola F, Pirondini C, Baumane K, Radecka L, and Ratiglia R

Subjects
Adult, Double-Blind Method, Drug Combinations, Dry Eye Syndromes metabolism, Dry Eye Syndromes physiopathology, Fluorophotometry, Humans, Lissamine Green Dyes metabolism, Nonprescription Drugs, Ophthalmic Solutions adverse effects, Preservatives, Pharmaceutical, Surveys and Questionnaires, Tears metabolism, Treatment Outcome, Dry Eye Syndromes drug therapy, Ophthalmic Solutions administration & dosage, Plant Extracts administration & dosage, Povidone administration & dosage
Abstract

Purpose: To study the safety and efficacy of T-Clair SPHP700-3, a new over-the-counter preservative-free formulation, in the management of mild to moderate dry eye in adults., Methods: Sixty adult patients with mild to moderate dry eye were consecutively recruited in 2 eye clinics and randomized into 2 groups: treatment and placebo. Signs and symptoms of dry eye were compared along 28 days of treatment., Results: No adverse events were reported during the study. Symptoms and signs of dry eye showed significant differences between the 2 groups after 2 and 4 weeks of treatment., Conclusions: SPHP700-3 preservative-free formulation showed to be safe and effective in mild to moderate dry eye, improving tear film stability, ocular surface lubrification, and patients' symptomatology.

Published
2011
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