Travoprost

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Travoprost
    1. Pharmacist Assessment Report
    2. Travoprost: From Open-Angle Glaucoma to Visceral Calciphylaxis
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. Australia Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Travoprost: From Open-Angle Glaucoma to Visceral Calciphylaxis

One-Sentence Summary

Travoprost is a topical prostaglandin F2-alpha analogue (FP receptor agonist) used as eye drops for open-angle glaucoma and ocular hypertension. The TxGNN model predicts it may be relevant to visceral calciphylaxis, but no clinical trials and no publications directly study this disease, so the prediction rests on the model score alone.


Quick Overview

Item Content
Original Indication Open-angle glaucoma and ocular hypertension (relation recorded in the knowledge graph; the ARTG record in the data compiled for this report contains no indication text)
Predicted New Indication Visceral calciphylaxis
TxGNN Prediction Score 1.0000
Evidence Level L5
Australia Market Status Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items 1 (valid: 1)
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data are not available in the data compiled for this report. Travoprost is generally understood to be a prostaglandin F2-alpha analogue that acts on the FP receptor to lower intraocular pressure by increasing uveoscleral outflow.

No established link exists between FP receptor agonism and the vascular calcification pathways involved in calciphylaxis. In addition, topical ocular dosing gives minimal systemic exposure. The prediction should be treated as a model-generated hypothesis only, and the similarity to the original indication has not been assessed.

The other top-ranked predictions (venous, arterial and neurogenic thoracic outlet syndrome, vascular disease, gastric angiodysplasia, blue toe syndrome, spontaneous coronary artery dissection, lymphangiectasis and hemangioendothelioma) also have no supporting trials or literature for efficacy. The one partial exception is “vascular disease”, discussed below.


Clinical Trial Evidence

Currently no related clinical trials registered for visceral calciphylaxis.

For context, the trials retrieved for the broader prediction “vascular disease” (rank 5) are all in glaucoma or ocular hypertension, the original indication. They do not test a vascular disease treatment. The most relevant of these were:

Trial Number Phase Status Enrolment Key Findings
NCT00308945 Phase 4 Completed 20 Travoprost vs latanoprost effects on retinal vascular diameter and choroidal blood flow in glaucoma patients (indirect ocular haemodynamic data only)
NCT00293761 Phase 3 Completed 109 Glaucoma therapy in open-angle glaucoma or ocular hypertension
NCT00760539 Phase 3 Completed 87 Travoprost/timolol BAK-free vs standard fixed combination for IOP lowering
NCT00672997 Phase 3 Completed 301 Travoprost/timolol BAK-free vs standard fixed combination for IOP lowering
NCT01510145 Phase 4 Completed 191 BAK-free travoprost after switching from latanoprost
NCT02136589 Phase 4 Completed 40 NSAID effect on travoprost-induced conjunctival hyperaemia (a side effect)

Literature Evidence

Currently no related literature available for visceral calciphylaxis.

Literature retrieved for neighbouring predictions, which does not support efficacy in these conditions:

PMID Year Type Journal Key Findings
28458346 2017 Database analysis Biol Pharm Bull Spontaneous adverse event reports suggest an association between topical PGF2α analogues and blood pressure elevation (a safety signal)
12664369 2003 Preclinical (ex vivo) Klin Monatsbl Augenheilkd Travoprost showed no vasoactive properties in isolated porcine ciliary arteries
19107053 2008 Case report J Fr Ophtalmol Uveal effusion induced by topical travoprost in a patient with Sturge-Weber-Krabbe syndrome (an adverse event, relevant to hemangioendothelioma rank 10)
25867658 2015 Systematic review Curr Med Res Opin Efficacy and tolerability of prostaglandin-timolol fixed combinations in glaucoma

Australia Market Information

ARTG Number Product Name Dosage Form Approved Indication
ARTG 14549R Travatan Eye drops 40 micrograms per mL, 2.5 mL Not stated in the data compiled for this report

Only one single-ingredient licence is listed, and its status is valid. The only available dosage form is ophthalmic, which differs from what a systemic condition such as visceral calciphylaxis would likely need.


Safety Considerations

  • Relations recorded in the knowledge graph (not label text): The knowledge graph links travoprost to the following conditions as contraindications: uveitis, iris disease, ciliary body disease, panuveitis, iritis, cystoid macular oedema and macular retinal oedema. These should be verified against the Product Information.
  • Blood pressure: Spontaneous report analyses suggest topical PGF2α analogues may be associated with blood pressure elevation (PMID 28458346). This is a theoretical concern for vascular conditions.
  • Vascular anomalies: A case report describes uveal effusion with topical travoprost in a patient with Sturge-Weber-Krabbe syndrome, suggesting caution in patients with vascular malformations.
  • Drug interactions: 49 interactions were identified, all with an unknown severity level. Examples include calcitriol, pantoprazole, sucralfate, morphine, metformin, omeprazole, prednisone, simvastatin and acetylsalicylic acid. Their clinical significance is not established.

Please refer to the TGA-approved Product Information (PI) for full warnings and contraindications.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by the model score. No trials or publications study travoprost in visceral calciphylaxis, there is no plausible mechanistic link, and topical ocular dosing offers little systemic exposure. Evidence level is L5.

To proceed, the following is needed:

  • Mechanism of action data and a plausible biological link between FP receptor agonism and calciphylaxis or vascular calcification
  • Preclinical evidence in a relevant model of calciphylaxis
  • A route and formulation assessment, since only an ophthalmic product is registered
  • The TGA Product Information, to confirm warnings, contraindications and the approved indication text
  • Review of the blood pressure signal and vascular safety concerns

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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