Evidence map›Paper›PMID 38839719›Full record

ArticlePharmaceutical research2024

Topical Solution for Retinal Delivery: Bevacizumab and Ranibizumab Eye Drops in Anti-Aggregation Formula (AAF) in Rabbits.

Steven A Giannos, Edward R Kraft, Jonathan D Luisi, Mary E Schmitz-Brown, Valentina Reffatto, Kevin H Merkley, Praveena K Gupta

Abstract read
In one paragraph

Article in Pharmaceutical research, 2024. 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
–field-weighted citation impact
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.

  1. Review
  2. Review
  3. Article
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

7 authors.

Steven A GiannosDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA. stevena.giannos@viatris.com.ORCID http://orcid.org/0000-0003-3574-4053
Edward R KraftDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA.
Jonathan D LuisiDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA.
Mary E Schmitz-BrownDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA.
Valentina ReffattoDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA.
Kevin H MerkleyDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA.
Praveena K GuptaDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA. prgupta@utmb.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWet age-related macular degeneration (AMD) is a blinding retinal disease. Monthly intravitreal anti-VEGF antibody injections of bevacizumab (off-label) and ranibizumab (FDA approved) are the standard of care. Antibody aggregation may interfere with ocular absorption/distribution. This study assessed topical delivery of dilute antibodies to the posterior segment of rabbit eyes using a novel anti-aggregation formula (AAF).

methodsBevacizumab, or biosimilar ranibizumab was diluted to 5 mg/ml in AAF. All rabbits were dosed twice daily. Substudy 1 rabbits (bevacizumab, 100 µl eye drops): Group 1 (bevacizumab/AAF, n = 6); Group 2 (bevacizumab/PBS, n = 7) and Vehicle control (AAF, n = 1). Substudy 2 rabbits (ranibizumab biosimilar/AAF, 50 µl eye drops): (ranibizumab biosimilar/AAF, n = 8). At 14.5 days, serum was drawn from rabbits. Aqueous, vitreous and retina samples were recovered from eyes and placed into AAF aliquots. Tissue analyzed using AAF as diluent.

resultsBevacizumab in AAF permeated/accumulated in rabbit aqueous, vitreous and retina 10 times more, than when diluted in PBS. AAF/0.1% hyaluronic acid eye drops, dosed twice daily, provided mean tissue concentrations (ng/g) in retina (29.50), aqueous (12.34), vitreous (3.46), and serum (0.28 ng/ml). Additionally, the highest concentration (ng/g) of ranibizumab biosimilar was present in the retina (18.0), followed by aqueous (7.82) and vitreous (1.47). Serum concentration was negligible (< 0.04 ng/ml). No irritation was observed throughout the studies.

conclusionsBevacizumab and ranibizumab, in an AAF diluent eye drop, can be delivered to the retina, by the twice daily dosing of a low concentration mAb formulation. This may prove to be an adjunct to intravitreal injections.

Indexed as

BevacizumabOphthalmic SolutionsRanibizumabRetinaAngiogenesis InhibitorsAnimalsBiosimilar PharmaceuticalsIntravitreal InjectionsRabbitsVascular Endothelial Growth Factor AVitreous BodyWet Macular DegenerationAngiogenesis InhibitorsBevacizumabBiosimilar PharmaceuticalsOphthalmic SolutionsRanibizumabVascular Endothelial Growth Factor Aantibodyanti-VEGFmacular degenerationneovascularizationretina

Identifiers

PMID38839719
PMCPMC11196329

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.