Hyaluronidase
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Hyaluronidase: From Registered Injectable Use to Esotropia
One-Sentence Summary
Hyaluronidase is an enzyme injection that is registered and marketed in Singapore, although the register does not state its approved indication. The TxGNN model predicts it may be effective for esotropia (inward-turning eye), but no clinical trials and only 1 publication exist for this prediction. That publication describes strabismus as a complication after eye anaesthesia, not as something hyaluronidase treats, so the evidence is very weak.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore registration record |
| Predicted New Indication | Esotropia |
| TxGNN Prediction Score | 99.89% |
| Evidence Level | L4 (in practice, close to model prediction only) |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for this drug. Hyaluronidase is an enzyme that breaks down hyaluronan, a component of tissue "scaffolding". In ophthalmic practice it is used as an additive to local anaesthetic injections to help the anaesthetic spread.
The only publication linked to esotropia (PMID 16934027) reports persistent double vision and strabismus after cataract surgery under local anaesthesia. Hyaluronidase appears there as part of the anaesthetic block, and the strabismus is a possible complication of that block. It is not a condition the drug treats.
No therapeutic mechanism connecting hyaluronidase to esotropia has been established. The very high TxGNN score is not backed by clinical evidence, so this prediction should be regarded as a model artefact until shown otherwise.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 16934027 | 2006 | Case report/Review | Binocular Vision & Strabismus Quarterly | Describes persistent diplopia and strabismus as a complication of retrobulbar local anaesthesia after cataract surgery, along with clinical features and treatments for that complication. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN10302P | HYALASE Powder for Injection 1500 iu/ampoule (CP Pharmaceuticals Ltd) | Injection, powder, for solution | Not stated in the register |
All registered forms are injectable. The license is valid, and it is a single-ingredient product.
Safety Considerations
- Drug Interactions: 63 interactions are recorded. The 20 listed in the data compiled for this report are all classed as Minor. They include corticosteroids (hydrocortisone, triamcinolone, dexamethasone, betamethasone, budesonide, prednisolone, prednisone), antihistamines (promethazine, chlorpheniramine, acrivastine, loratadine, cetirizine, brompheniramine, phenyltoloxamine), local anaesthetics (lidocaine, articaine), oestrogens (ethinylestradiol, estradiol, conjugated estrogens) and aspirin. The remaining 43 were not itemised.
- Hypersensitivity: A 2024 review in the literature for other predicted indications notes that allergic reactions to hyaluronidase injection are described and often misdiagnosed. This is background context, not label information.
Please refer to the package insert for warnings and contraindications, as these were not available.
Conclusion and Next Steps
Decision: Hold
Rationale: There are no trials, and the only publication describes strabismus as a complication of an anaesthetic block, not a treatment effect. The prediction has no supporting mechanism or clinical evidence.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA, and the approved indication for SIN10302P
- Mechanism of action data
- Any evidence that hyaluronidase has a therapeutic role in esotropia, which currently does not exist
Note on other predictions: Among the other indications predicted for this drug, diabetic retinopathy has far stronger support. It has two completed Phase 3 trials of intravitreal hyaluronidase for vitreous haemorrhage (NCT00198497, n=510; NCT00198510, n=750) and a Phase 2 study (NCT00198471, n=10). However, outcome data were not available, and the indication was reportedly not ultimately approved. It would be a more sensible candidate for further review than esotropia, once published results are retrieved and benefit-risk is checked.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.