Latanoprost

Evidence Level: L2

Predicted Indications: 10

Latanoprost
Latanoprost: From Open-Angle Glaucoma and Ocular Hypertension to Primary Hereditary Glaucoma

## Pharmacist Assessment Report

Latanoprost: From Open-Angle Glaucoma and Ocular Hypertension to Primary Hereditary Glaucoma

One-Sentence Summary

Latanoprost is a prostaglandin F2-alpha analogue eye drop, used to lower intraocular pressure in adult glaucoma. The TxGNN model predicts it may be effective for primary hereditary glaucoma, with 1 completed Phase 2 clinical trial and no publications currently supporting this direction.

Quick Overview

Item	Content
Original Indication	Adult open-angle glaucoma and ocular hypertension (inferred from the mechanistic rationale; the license records list no indication text, so confirm against the label)
Predicted New Indication	Primary hereditary glaucoma
TxGNN Prediction Score	99.88%
Evidence Level	L2
US Market Status	✓ Marketed
Number of NDAs	17 (the sampled licenses are generic ANDAs)
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the record. Latanoprost is an FP-receptor agonist. It lowers intraocular pressure by increasing uveoscleral outflow of aqueous humour.

Glaucoma of any subtype involves optic neuropathy driven by intraocular pressure, so lowering pressure is the shared treatment goal. Primary hereditary glaucoma is therefore an extension to a genetic or congenital subtype, not a new mechanism. The pediatric trial below tests this in children whose glaucoma did not respond to surgery.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT01527682	Phase 2	Completed	37	Latanoprost and dorzolamide in primary pediatric glaucoma refractory to surgery. The study measured the ocular hypotensive effect and safety (2009-07 to 2016-11). No efficacy results were provided.

The trial is a small combination-regimen study, so the latanoprost-specific effect cannot be separated out. The population (for example, primary congenital or hereditary glaucoma) is also not fully confirmed.

Literature Evidence

Currently no related literature available.

US Market Information

Authorization Number	Product Name	Dosage Form	Manufacturer
ANDA091449	Latanoprost	Solution	Sandoz Inc
ANDA218257	Latanoprost	Solution/Drops	Sagent Pharmaceuticals
ANDA091449	Latanoprost	Solution	A-S Medication Solutions
ANDA202442	Latanoprost	Solution	Rising Pharma Holdings, Inc.
ANDA218257	Latanoprost	Solution/Drops	Glenmark Pharmaceuticals Inc

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: One completed Phase 2 trial (n=37) in pediatric glaucoma, together with a clear pressure-lowering mechanism, supports this prediction. The evidence is small and gives no efficacy results, and safety data are missing, so it should advance only with safeguards.

To proceed, the following is needed:

Trial results or publications for NCT01527682, plus a check of the population and the latanoprost-only effect
The US package insert (warnings, contraindications, pediatric use) and the on-label indication
Detailed mechanism of action data from DrugBank
A pediatric safety monitoring plan

Other predictions:

Hypotrichosis simplex of the scalp is a plausible research question, based on the known hair-growth effect of FP agonists. It has no trials or literature.
The other eight predictions (visceral calciphylaxis, arterial, venous and neurogenic thoracic outlet syndromes, congenital hypotrichosis milia, gastric angiodysplasia, blue toe syndrome, lymphangiectasis) have no clear mechanistic link and no evidence. They should be held.

This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.

Disclaimer

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