Evidence map›Paper›PMID 27556217›Full record

ArticleInvestigative ophthalmology & visual science2016

Biocompatibility and Pharmacokinetic Analysis of an Intracameral Polycaprolactone Drug Delivery Implant for Glaucoma.

Jean Kim, Max Kudisch, Sri Mudumba, Hiroyuki Asada, Eri Aya-Shibuya, Robert B Bhisitkul, Tejal A Desai

Open access · goldAbstract read
In one paragraph

Article in Investigative ophthalmology & visual science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
5.8field-weighted citation impact, top 4% 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

30 citing papers in PubMed, 69 citations in OpenAlex.

  1. Trial
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  5. Nanotechnology-Based Treatment for Ophthalmic Diseases.International journal of nanomedicine · 2026
    Review
  6. Review
  7. Review
  8. Article
  9. Biodegradable Polymer-Based Drug-Delivery Systems for Ocular Diseases.International journal of molecular sciences · 2023
    Review
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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

7 authors at 3 institutions in 2 countries.

Jean KimUCB-UCSF Graduate Program in Bioengineering, San Francisco, California, United States.
Max KudischDepartment of Ophthalmology, University of California, San Francisco, San Francisco, California, United States.
Sri MudumbaSanten, Inc., Emeryville, California, United States.
Hiroyuki AsadaSanten Pharmaceutical Co., Ltd., Nara RD Center, Nara, Japan.
Eri Aya-ShibuyaSanten Pharmaceutical Co., Ltd., Nara RD Center, Nara, Japan.
Robert B BhisitkulDepartment of Ophthalmology, University of California, San Francisco, San Francisco, California, United States.
Tejal A DesaiDepartment of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, California, United States.
University of California, San Francisco · USSanten (Japan) · JPSanten (United States) · US

Funding

UCSF/UCB Joint Graduate Group in BIoengineeringT32GM008155 · NIGMS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DESAI, TEJAL A. · 1985 to 2020
$12.2M
Nanoporous Films for Ocular Drug DeliveryR01EY021574 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DESAI, TEJAL A. · 2011 to 2014
$1.5M
NEI NIH HHS R01 EY021574NIGMS NIH HHS T32 GM008155
6 · The paper itself

Abstract

purposeWe developed polycaprolactone (PCL) implants that achieve zero-order release of a proprietary ocular hypotensive agent (DE-117) over 6 months.

methodsThe release rates of DE-117-loaded PCL devices were tuned based on an established predictive model and confirmed by in vitro release studies. Devices containing DE-117 and empty devices were implanted intracamerally in normotensive rabbits for up to 8 weeks' duration. Devices were retrieved after rabbits were euthanized and evaluated for tissue adherence. The drug remaining in each device was analyzed by high performance liquid chromatography. Drug distribution in ocular tissues was measured by liquid chromatography coupled with a tandem mass spectrometry (LC/MS/MS).

resultsIn vitro release of DE-117 showed zero-order release with a release rate of 0.5 μg/day over 6 months. Implantation in rabbit eyes demonstrated that the devices were well tolerated in the intracameral space. Quantification of DE-117 and hDE-117 (the hydrolyzed active form of DE-117) in ocular tissues (cornea, iris-ciliary body, aqueous humor, and vitreous humor) indicated sustained release of DE-117 and its conversion to hDE-117 when released from the device. Analysis of drug remaining in the device found that concentration of hDE-117 was below the limit of detection, indicating the encapsulated drug was protected from hydrolysis in the device.

conclusionsProof-of-concept PCL drug delivery devices containing DE-117 show promise as a long-term glaucoma treatment based on their zero-order drug release profile in vitro, biocompatibility in vivo, and effective distribution of released drug in relevant ocular tissues.

Indexed as

PolyestersAnimalsAnterior ChamberAqueous HumorChromatography, LiquidDrug Delivery SystemsDrug ImplantsFollow-Up StudiesGlaucomaMaterials TestingProstaglandins A, SyntheticRabbitsTandem Mass SpectrometryDrug ImplantspolycaprolactonePolyestersProstaglandins A, Synthetic

Identifiers

PMID27556217
PMCPMC5015984
OpenAlexW2509660593

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.