Evidence map›Paper›PMID 34113182›Full record

ArticleJournal of experimental pharmacology2021

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

Patricia Muñoz-Villegas, Alejandra Sanchez-Rios, Mayra G Quinonez-Alvarado, Oscar Olvera-Montaño, Juan D Quintana-Hau, Leopoldo Baiza-Duran

Open access · goldAbstract read
In one paragraph

Article in Journal of experimental pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Patricia Muñoz-VillegasMedical Affairs Department, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, México.ORCID 0000-0002-7559-1218
Alejandra Sanchez-RiosMedical Affairs Department, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, México.
Mayra G Quinonez-AlvaradoResearch and Development Department (CIS), Zapopan, Jalisco, México.
Oscar Olvera-MontañoMedical Affairs Department, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, México.ORCID 0000-0003-2717-349X
Juan D Quintana-HauResearch and Development Department (CIS), Zapopan, Jalisco, México.
Leopoldo Baiza-DuranMedical Affairs Department, Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, México.
Laboratorios Sophia (Mexico) · MXCentro de Investigación y Proyectos en Ambiente y Desarrollo · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPRO-169 is a biosimilar candidate to bevacizumab (BEV), a monoclonal antibody (mAb) that inhibits vascular endothelial growth factor-A (VEGF-A) developed for intravitreal use. The current study demonstrates the intraocular pharmacokinetics (PK) of PRO-169 and its safety using New Zealand white (NZW) rabbits.

methodsIntraocular concentration was evaluated in thirty-six rabbits at 1h, 1, 2, 5, 14 and 30 days after a single bilateral injection of PRO-169 or BEV (1.25 mg/0.05 mL). In a secondary experiment, safety was evaluated after three consecutive unilateral injections at 30-day intervals in twenty-four rabbits (PRO-169: 1.25 mg/0.05 mL or ranibizumab [RZB]: 0.5 mg/0.05 mL), by liver-associated enzymes (LAE), ophthalmological examination and adverse event (AE) incidence. Primary endpoints were vitreous maximum concentration (C

resultsThe C

conclusionPRO-169 can be efficiently diffused and distributed in ocular compartments, showing vitreous pharmacokinetics analogous to BEV. The safety experiment did not find evidence of clinical alterations from a repeated injection of PRO-169. These results provide scientific justification supporting that PRO-169 should be evaluated in future clinical trials to confirm its safety and efficacy.

Indexed as

bevacizumabpharmacokineticsranibizumabsafetyvascular endothelial growth factor

Identifiers

PMID34113182
PMCPMC8185251
OpenAlexW3173023661

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.