Lidocaine

Evidence Level: L5

Predicted Indications: 10

Lidocaine

Pharmacist Assessment Report

Lidocaine: From Local Anaesthesia and Neuralgia to Punctate Epithelial Keratoconjunctivitis

One-Sentence Summary

Lidocaine is a sodium channel–blocking local anaesthetic. The TxGNN model predicts it may be effective for punctate epithelial keratoconjunctivitis, but no clinical trials and no publications directly study this disease, so the prediction rests on the model alone.

Quick Overview

Item	Content
Original Indication	Relations recorded in the knowledge graph (not label-confirmed approvals): dermatitis, neuralgia, haemorrhoids, postherpetic neuralgia, scabies and others. The licence records compiled for this report contain no approved indication text.
Predicted New Indication	Punctate epithelial keratoconjunctivitis
TxGNN Prediction Score	0.9999
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Number of Approvals	At least 20 licences (the list may be partial)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Based on general knowledge, lidocaine blocks voltage-gated sodium channels and is used as a local anaesthetic, including on the ocular surface.

The link to the predicted disease is weak. A topical anaesthetic could in theory relieve surface pain, but it would not treat the underlying keratoconjunctivitis. Topical anaesthetics can also impair corneal epithelial healing, which is a safety concern for this kind of condition. The high model score therefore should not be read as support for therapeutic benefit.

Clinical Trial Evidence

Currently no related clinical trials registered for punctate epithelial keratoconjunctivitis.

For context, the model’s other eye-related predictions have some registered trials, but none address the predicted disease here. For example, for the lower-ranked “conjunctival disorder” prediction, the trials concern anaesthesia during eye surgery (for example, NCT05978687, a completed Phase 4 trial of lidocaine gel versus subconjunctival injection in pterygium excision, n=41). These test anaesthetic technique, not treatment of the disease.

Literature Evidence

Currently no related literature available for punctate epithelial keratoconjunctivitis.

India Market Information

At least 20 single-ingredient lidocaine licences are valid in India; the list below shows 5 and may be partial. None of the records include approved indication text.

Authorization Number	Product Name	Dosage Form	Approved Indication
Registration No. 125383	Lidofix 2% Injection	Vial of 30 ml injection	Not stated in the records
Registration No. 127832	Lignocip 2% Injection	Vial of 30 ml injection	Not stated in the records
Registration No. 121665	Lignox 2% Gel	Tube of 30 gm gel	Not stated in the records
Registration No. 203383	Skore Not Out Lidocaine Topical Spray	Bottle of 12 gm spray	Not stated in the records
Registration No. 162965	Oculan 1% Injection	Vial of 1 ml injection	Not stated in the records

Available forms include injections, gel, spray, oral topical solution and transdermal patch.

Safety Considerations

Contraindications (knowledge-graph relations, not label text): the knowledge graph records contraindication relations with conditions including hypertension, liver failure, liver disease, cirrhosis, kidney disease, epilepsy, open-angle glaucoma, herpes simplex virus keratitis, adrenocortical insufficiency, hypothyroidism, atopic dermatitis, osteoporosis, psychotic disorders, fungal infections and gastritis.
Drug Interactions: 100 interactions were found. The main ones include:
- Major: bupropion.
- Moderate: aprepitant, cimetidine, liposomal morphine, obeticholic acid, polyethylene glycol (3350 with electrolytes), picosulfuric acid, sodium sulfate.
- Minor: dexamethasone, kanamycin, neomycin, omeprazole, streptomycin, troglitazone.
Eye-specific concern: misuse of topical anaesthetics is known to cause corneal damage, and the model’s predicted use is on the ocular surface.
Other literature in the compiled data documents neuropsychiatric adverse effects of lidocaine, a case of methemoglobinemia when combined with other topical agents, and seizures in animals at low doses given in a combination preparation.

Please also refer to the package insert, as label warnings were not available.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction score is very high, but no trial or publication directly studies lidocaine for punctate epithelial keratoconjunctivitis, so the evidence level is L5. The plausible mechanism (surface anaesthesia) would only relieve symptoms, and topical anaesthetics may harm corneal healing.

To proceed, the following is needed:

Direct preclinical or clinical evidence in punctate epithelial keratoconjunctivitis
Corneal safety assessment for repeated ocular-surface use
Package insert warnings and contraindications from India licence documents
Mechanism of action data from DrugBank
Disclaimer

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