Evidence map›Paper›PMID 39946034›Full record

Trial reportDrugs2025

Prospective 18-Month Study of Bimatoprost Intracameral Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension in US Clinical Practice.

Eric Mann, Jeffrey A Kammer, Gagan Sawhney, Jella An, Erica C Werts, Vanessa Vera, Marcos Rivas, Hongxin Lai, Sadhana Sonparote, E Randy Craven

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter StudyObservational Study
In one paragraph

Trial report in Drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04647214 (ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT04647214 completednot on this map

ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice

TypeobservationalSponsorAllerganRan2021 to 2024Enrolled220ConditionsOpen-angle Glaucoma, Ocular Hypertension
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Computational study of DurystaDrug delivery and translational research · 2026
    Article
  2. Review
  3. Review
  4. Overview of Intracameral Drug Delivery Systems in Glaucoma.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Review
  5. Article
  6. Article
  7. Article
  8. 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

10 authors.

Eric MannThe Research Center at Eye Associates of North Jersey, Dover, NJ, USA.
Jeffrey A KammerVanderbilt Eye Institute, Vanderbilt University School of Medicine, Nashville, TN, USA.ORCID http://orcid.org/0000-0002-9422-4771
Gagan SawhneyGeorgia Eye Partners, Atlanta, GA, USA.
Jella AnStorm Eye Institute, Medical University of South Carolina, Charleston, SC, USA.ORCID http://orcid.org/0000-0001-7811-8357
Erica C WertsAllergan, an AbbVie company, Irvine, CA, USA.
Vanessa VeraAllergan, an AbbVie company, Irvine, CA, USA.
Marcos RivasAbbVie, Madrid, Spain.
Hongxin LaiAllergan, an AbbVie company, Irvine, CA, USA.
Sadhana SonparoteAllergan, an AbbVie company, Irvine, CA, USA.
E Randy CravenAllergan, an AbbVie company, 2525 Dupont Drive, Irvine, CA, 92612, USA. randy.craven@abbvie.com.ORCID http://orcid.org/0000-0002-2077-659X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveBimatoprost implant 10 µg (Durysta) is an intracameral biodegradable implant that releases bimatoprost to lower intraocular pressure (IOP). The purpose of this study was to prospectively collect effectiveness and safety data after administration of the implant in patients with open-angle glaucoma or ocular hypertension.

methodsThis phase IV, multicenter, prospective, observational, open-label, 18-month study (ARGOS) enrolled adult patients with open-angle glaucoma or ocular hypertension who were scheduled to receive the bimatoprost implant in one or both eyes. Data collected included IOP, use of topical IOP-lowering medications, treatment-emergent adverse events, and central corneal endothelial cell density. The primary endpoint was the proportion of primary (first-treated) eyes that received no additional (new) IOP-lowering treatment per standard medical care through month 6 after the implant administration.

resultsA total of 217 patients (341 eyes) were enrolled, and 132 patients (60.8%) and 203 eyes (59.5%) completed the study. Most patients were on topical IOP-lowering medication before receiving the implant. After implant administration, the proportion of primary eyes that had received no additional treatment was 88.6% (95% confidence interval 86.6-90.6) at month 6 (primary endpoint) and remained high throughout the follow-up: 83.7% (95% confidence interval 80.2-87.3) at month 12 and 77.7% (95% confidence interval 73.4-82.1) at month 18. Intraocular pressure was reduced after implant administration, with mean changes in IOP from baseline at follow-up visits ranging from - 1.0 to - 2.0 mm Hg. The mean number of topical IOP-lowering medications used was also reduced, from 1.8 at baseline to 0.9 at month 12 and 1.0 at month 18. Increased IOP and dry eye were the most common ocular treatment-emergent adverse events. The mean percentage change in central corneal endothelial cell density from baseline at month 18 (central reading center evaluation) was - 3.47%. In qualitative interviews, most patients (84%, 21/25) reported overall satisfaction with their treatment outcomes.

conclusionsThe bimatoprost implant helped control IOP and decrease topical medication use. Throughout the 18 months after implant administration, an estimated 77.7% of eyes required no new added medication for IOP management. Patient-reported outcomes were favorable, and the safety profile of the implant was acceptable. CLINICAL

trial registrationClinicalTrials.gov identifier NCT04647214, registered 23 November, 2020.

Indexed as

Antihypertensive AgentsBimatoprostDrug ImplantsGlaucoma, Open-AngleOcular HypertensionAdultAgedAged, 80 and overFemaleHumansIntraocular PressureMaleMiddle AgedProspective StudiesTreatment OutcomeUnited StatesAntihypertensive AgentsBimatoprostDrug Implants

Identifiers

PMID39946034
PMCPMC11891102

What OpenQuestion holds

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Registered trials

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.