Evidence map›Paper›PMID 36651217›Full record

ArticleClinical and translational science2023

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs.

Ingrid M Pruimboom-Brees, Swati Gupta, Nagendra Chemuturi, Helen S Booler, Erik Nimz, Meg Ferrell Ramos, Antonello Caruso, Katie F Maass, Vladimir Bantseev, Qihong Huang and 5 more

Abstract read
In one paragraph

Article in Clinical and translational science, 2023. 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. Article
  2. Article
  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

15 authors.

Ingrid M Pruimboom-BreesNovartis Institutes of Biomedical Research, Basel, Switzerland.
Swati GuptaAbbVie, Irvine, California, USA.ORCID 0000-0002-3727-6647
Nagendra ChemuturiTakeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.
Helen S BoolerNovartis Institutes of Biomedical Research, Basel, Switzerland.
Erik NimzNovartis Institutes of Biomedical Research, Basel, Switzerland.
Meg Ferrell RamosAbbVie, Irvine, California, USA.ORCID 0000-0003-4149-4740
Antonello CarusoRoche, Basel, Switzerland.
Katie F MaassGenentech, Inc., South San Francisco, California, USA.ORCID 0000-0002-0493-2863
Vladimir BantseevGenentech, Inc., South San Francisco, California, USA.
Qihong HuangBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA.
Mary P ChoulesAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Jesse C NussbaumMerck & Co., Inc., South San Francisco, California, USA.
Jitendra KanodiaXencor, South San Francisco, California, USA.ORCID 0000-0001-8621-500X
Christopher ThompsonDecibel Therapeutics, Boston, Massachusetts, USA.
Chandrasekar DurairajTakeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The eye, which is under constant exposure to environmental pathogens, has evolved various anatomic and immunological barriers critical to the protection of tissues lacking regenerative capacity, and the maintenance of a clear optic pathway essential to vision. By bypassing the ocular barriers, intravitreal (IVT) injection has become the mainstay for the delivery of drugs to treat conditions that affect the back of the eye. Both small molecules and biotherapeutics have been successfully administered intravitreally, and several drugs have been approved for the treatment of (wet) age-related macular degeneration and diabetic macular edema. However, IVT injection is an invasive procedure, which requires sufficient technical expertise from the healthcare professional administering the drug. Potential side effects include bleeding, retinal tear, cataracts, infection, uveitis, loss of vision, and increased ocular pressure. Pharmaceutical companies often differ in their drug development plan, including drug administration techniques, collection of ocular tissues and fluids, ophthalmology monitoring, and overall conduct of nonclinical and clinical studies. The present effort, under the aegis of the Innovation & Quality Ophthalmic Working Group, aims at understanding these differences, identifying pros and cons of the various approaches, determining the gaps in knowledge, and suggesting feasible good practices for nonclinical and early clinical IVT drug development.

Indexed as

Diabetic RetinopathyMacular EdemaHumansIntravitreal InjectionsPharmaceutical PreparationsPharmaceutical Preparations

Identifiers

PMID36651217
PMCPMC10175998

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.