Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab

Muñoz‐Villegas, Patricia; Sánchez‐Ríos, Alejandra; Quiñonez-Alvarado, Mayra G; Olvera‐Montaño, Oscar; Quintana-Hau, Juan D; Baiza-Durán, Leopoldo Martín

doi:10.2147/jep.s308388

Cited by 5 publications

(3 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Di Antonio et al [48] performed IVA treatment on 15 eyes of mCNV patients and finally found that the patients not only showed improved BCVA but also reduced central retinal thickness significantly, as well as having decreased levels of VEGF and placental growth factor (PIGF). In addition, bevacizumab is a humanized monoclonal antibody (IgG1) targeting VEGF-A to inhibit angiogenesis, and is composed mainly of an Fab region that binds to the target and an Fc region that performs an effector function [49] . Fothurmore, ranibizumab is also a humanized monoclonal antibody fragment, but it only contains an Fab fragment, which can also inhibit VEGF-A and prevent the formation of new blood vessels [50] .…”

Section: Discussionmentioning

confidence: 99%

Different approaches for treating myopic choroidal neovascularization: a network Meta-analysis

Wu,

Yang,

Fan

et al. 2023

Int J Ophthalmol

View full text Add to dashboard Cite

AIM: To evaluate the efficacy of intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF), photodynamic therapy (PDT), and laser treatment (LT) for anatomical and functional improvement in myopic choroidal neovascularization (mCNV) patients. METHODS: Two researchers independently searched PubMed, Cochrane Library, Web of Science, and other databases to screen studies comparing best-corrected vision acuity (BCVA) and foveal center thickness (FCT) changes after mCNV treatment. Post-treatment chorioretinal atrophy (CRA) is a secondary outcome indicator. The retrieval time limit is from the database construction to January 30, 2023. RESULTS: A total of 1072 eyes in 16 articles were included. In the RCTs, intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) were superior to PDT (MD=0.18, 95%CI: 0.02, 0.40, MD=0.18, 95%CI: 0.01, 0.42) in improving BCVA of mCNV patients (P<0.05). The relative effectiveness in improving BCVA, from high to low, appeared to be IVR, intravitreal aflibercept (IVA), IVB, LT, PDT, and sham first followed by IVA (Sham/IVA). While improving the FCT from high to low was IVA, IVR, IVB, PDT. In retrospective studies, the results of BCVA after long-term treatment showed that all the therapeutic effects from high to low was IVA, intravitreal conbercept (IVC), IVR, IVB, IVB/IVR, PDT with IVB/IVR, PDT. The effect of improving FCT was IVA, IVR, IVC, PDT, and IVB from high to low. And in the effects of improving CRA, the IVB appeared to be higher than IVR, while the PDT was the smallest, but none of the differences in the results were statistically significant. CONCLUSION: Anti-VEGF has the best effect on long-term vision improvement in mCNV patients, using IVB or IVR alone to treat mCNV may be better than IVB or IVR combined with PDT. There is no significant difference in the improvement of visual acuity, macular edema, and CRA in mCNV patients treated with any different anti-VEGF drugs.

show abstract

Section: Discussionmentioning

confidence: 99%

Different approaches for treating myopic choroidal neovascularization: a network Meta-analysis

Wu,

Yang,

Fan

et al. 2023

Int J Ophthalmol

View full text Add to dashboard Cite

show abstract

“…43 Besides, bevacizumab is a humanized monoclonal antibody (IgG1) targeting VEGF-A to inhibit angiogenesis, in addition, it is mainly composed of a fab region that binds to the target and an Fc region that performs an effector function. 44 What's more, ranibizumab is also a humanized monoclonal antibody fragment, but it only contains Fab fragment, which can also inhibit VEGF-A and prevent the formation of new blood vessels. 45 As one of the most commonly used anti-VEGF drugs, ranibizumab, and bevacizumab are commonly used to compare e cacy with each other, but they are currently considered to have the same e cacy in improving visual acuity in mCNV patients without statistical difference.…”

Section: Discussionmentioning

confidence: 99%

Different approaches for the treatment of myopic choroidal neovascular: a network meta-analysis

Feng

Yang

et al. 2022

Preprint

View full text Add to dashboard Cite

Purpose: In order to evaluate the e cacy of intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) drugs, photodynamic therapy (PDT), and laser treatment (LT) for anatomical and functional improvement in myopic choroidal neovascularization (mCNV) patients were evaluated in a mesh meta-analysis. Methods: Two researchers independently searched PubMed, Cochrane Library, Web of Science, CNKI, WanFang Data, Embase, and other databases to screen RCTs and retrospective studies comparing best-corrected visual acuity (BCVA) and foveal center thickness (FCT) changes after mCNV treatment. The retrieval time limit is from the database construction to November 30, 2021. ADDIS1.16.8 and R 3.5.3 software were used to conduct mesh meta-analyses of RCTs and retrospective studies, respectively.Results: A total of 601 eyes in 8 RCTs involving 6 treatment options: intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), intravitreal conbercept (IVC), intravitreal a ibercept (IVA), LT, PDT, sham rst followed by IVA (Sham /IVA). The results of the mesh meta-analysis showed that: in the RCTs, IVB and IVR were superior to PDT [MD=0.18, 95%CI (0.01, 0.42)] in improving BCVA of mCNV patients, and all the therapeutic effects from high to low might be intravitreal IVA, IVB, IVR, LT, Sham/IVA, and PDT; the order of FCT thickness reduction from high to low is IVA, IVR, IVB, PDT. In addition, the results of BCVA after long-term treatment in retrospective studies showed that all the therapeutic effects from high to low might be IVA, IVC, IVB /IVR, IVB, IVR, PDT, PDT with IVB /IVR; as for the order of FCT thickness reduction from high to low is IVA, IVC, IVR, IVB, PDT.Conclusions: Anti-VEGF treatment in patients with long-term improvement in mCNV vision effect is best, using IVB or IVR alone to treat mCNV may be better than IVB or IVR combined with PDT; There was no signi cant difference in the improvement of visual acuity and macular edema in mCNV patients with different anti-VEGF drugs. Due to the limited number and quality of included literature, the above conclusions need to be con rmed by more large-sample and high-quality articles.

show abstract

“…When VEGF is overproduced, conditions such as DME, aged-related macular degeneration, or DR can occur. The severity of vascular leakage in DME correlates with the level of VEGF produced and therefore anti-VEGF agents, such as ranibizumab (Lucentis, Genentech Inc., South San Francisco, CA, USA), bevacizumab (Avastin, Genentech Inc, South San Francisco, CA, USA), PRO-169 (anti-VEGF monoclonal antibody for intravitreal administration, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico), are used to inhibit it [ 9 – 12 ]. Nevertheless, it has been suggested that the use of anti-VEGF agents may result in systemic absorption, leading to further reduction in plasma VEGF activity, which turn produces accelerated hypertension, worsening proteinuria, glomerular disease, and possible chronic renal function decline [ 2 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Relationship Between Diabetic Macular Edema and Renal Function in a Latino Population

et al. 2023

Self Cite

View full text Add to dashboard Cite

Introduction Diabetic macular edema (DME) is one of the leading causes of vision impairment. The relationship between DME and estimated glomerular filtration rate (eGFR) has not been clearly evaluated in Hispanic or Latino populations. The objective of this study was to evaluate the eGFR in a Latino population with DME. Methods A cross-sectional, observational, and descriptive study was carried out on the basis of a multicenter phase III clinical trial. Results A total of 82 subjects diagnosed with DME (36 women and 46 men) were included in the study. The mean age was 61.93 ± 6.71 years. Mean values of the blood chemistry parameters glycated hemoglobin and eGFR were 7.20 ± 0.95% and 74.42 ± 26.82 mL/min/1.73 m 2 , respectively. The time elapsed since diagnosis of diabetes mellitus was 15.30 ± 7.35 years, while the duration of DME was 1.41 ± 1.75 years. Mean values for central macular thickness (CMT) and total macular volume (TMV) were 440.99 ± 132.22 µm and 11.97 ± 2.11 mm 3 , respectively. DME duration had a negative correlation with TMV (Rho − 0.26, p < 0.05) and a positive correlation with mean arterial pressure (Rho 0.26, p < 0.05). CMT was correlated with TMV (Rho 0.43, p < 0.0001) and visual acuity (Rho 0.26, p < 0.05). No significant correlations were observed between eGFR and CMT, TMV, or any demographic variable ( p > 0.05). Chronic kidney disease (CKD) was associated with hypertension (OR 9.32, p = 0.035), elevated intraocular pressure (IOP) (OR 0.03, p = 0.011), and advanced age (OR 0.45, p = 0.011). CMT was significantly associated with TMV ( β = 27.69, p < 0.0001). Conclusions We did not find a correlation between eGFR and DME. Our findings suggest that the presence of hypertension is associated with a decrease in the GFR < 60 mL/min/1.73 m 2 , and CKD may be associated with advanced age and elevated IOP which may increase the risk for the development of glaucoma. Trial Registration NCT05217680 (clinicaltrials.gov). Supplementary Information The online version contains supplementary material available at 10.1007/s40123-023-00787-w.

show abstract

Pharmacokinetics and Safety of an Intravitreal Humanized Anti-VEGF-A Monoclonal Antibody (PRO-169), a Biosimilar Candidate to Bevacizumab

Cited by 5 publications

References 43 publications

Different approaches for treating myopic choroidal neovascularization: a network Meta-analysis

Different approaches for treating myopic choroidal neovascularization: a network Meta-analysis

Different approaches for the treatment of myopic choroidal neovascular: a network meta-analysis

Evaluation of the Relationship Between Diabetic Macular Edema and Renal Function in a Latino Population

Contact Info

Product

Resources

About