In short
Levocabastine is a non-sedating antihistamine medicine used as eye drops to relieve the signs and symptoms of seasonal allergic conjunctivitis. It is already authorised as a medicine in Spain under the name REACTINE Levocabastina 0.5 mg/ml eye drops. The two clinical trials in the EU registry that mention levocabastine are Phase 3 studies of house dust mite immunotherapy, where levocabastine eye drops are used as a rescue medication, not as the treatment being investigated.
Levocabastine is a chemically synthesised substance classified as a non-sedating histamine H1 antagonist. Its full chemical name is 1-(4-cyano-4-(4-fluorophenyl)cyclohexyl)-3-methyl-4-phenyl-4-piperidinecarboxylic acid. It is marketed under trade names including Livostin, Livocab, Levophta and Bilina.
Key points
- Levocabastine is a non-sedating H1 antihistamine used to treat allergic conjunctivitis.
- It is given as 0.5 mg/ml eye drops for ophthalmic use.
- Two Phase 3 trials in the EU registry use levocabastine eye drops as a rescue medication for house dust mite allergy.
- One trial enrolled 410 participants, the other 492 participants.
- Both trials are currently authorised and investigate subcutaneous immunotherapy, not levocabastine itself.
What is levocabastine?
Levocabastine is a non-sedating antihistamine medicine. The MeSH database lists it under the pharmacological action "Histamine H1 Antagonists, Non-Sedating" and notes that it is used for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. The substance is a chemical compound with the formula C26H29FN2O2 and is classified under ATC codes R01AC02 and S01GX02.
Levocabastine is already authorised as a medicine in Spain, where the product REACTINE Levocabastina 0.5 mg/ml colirio en suspensión is supplied by JNTL Consumer Health (Spain) S.L.
How does levocabastine work?
Levocabastine works by blocking histamine H1 receptors. Histamine is a substance released during allergic reactions, and blocking its action helps reduce symptoms such as itching, redness and watering of the eyes. Because it is a non-sedating antihistamine, it is less likely to cause drowsiness than older antihistamines. Drugs.com classifies levocabastine ophthalmic products in the drug class of ophthalmic antihistamines and decongestants.
Which conditions is levocabastine used or studied for?
- Seasonal allergic conjunctivitis: levocabastine is used for the temporary relief of the signs and symptoms of this condition.
- Allergic conjunctivitis: the ophthalmic form of levocabastine is listed for the treatment of allergic conjunctivitis.
- House dust mite allergy: in two Phase 3 trials, levocabastine eye drops are used as a rescue medication for patients with allergic rhinoconjunctivitis caused by house dust mites.
How is levocabastine given?
Levocabastine is given as eye drops. The authorised product in Spain is a 0.5 mg/ml eye drop suspension for ophthalmic use. The NHS dm+d browser lists two virtual medicinal products for levocabastine: a 0.05% nasal spray and 0.5 mg/ml eye drops. In the clinical trials, levocabastine eye drops are used as rescue medication at doses of 60 micrograms and 30 micrograms per administration.
What do the clinical trials show?
Levocabastine itself is not the main treatment being investigated in the two trials in the EU registry. Instead, levocabastine eye drops appear as an auxiliary rescue medication in Phase 3 trials of subcutaneous immunotherapy for house dust mite allergy.
Which conditions are studied in these trials?
The first trial studies patients with moderate to severe persistent allergic rhinoconjunctivitis caused by Dermatophagoides pteronyssinus and Dermatophagoides farinae, with or without controlled asthma. The second trial studies adolescents and adults with house dust mite-induced allergic rhinitis or rhinoconjunctivitis, with or without controlled allergic asthma.
What phases and status do these trials have?
Both trials are Phase 3 interventional studies and both are currently authorised. The first trial has 410 participants, and the second has 492 participants.
What are the trials measuring?
The first trial measures the change in the combined symptom and medication score (cSMS) from baseline after 12 subcutaneous immunotherapy doses, recorded in an electronic diary. The second trial measures the Adapted Rhinitis Combined Symptom and Medication Score (arCSMS) over a 4-week evaluation period following approximately 12 months of treatment.
What side effects are known?
The provided sources do not contain a side-effect profile for levocabastine. As a non-sedating antihistamine, it belongs to a class of medicines that generally causes fewer sedative effects than older antihistamines, but specific side effects for levocabastine are not described in the data provided.