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Bilastine Ophthalmic Solution 0.6%
Bilastine is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the eye.
Bilastine is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the eye. Used for Allergic conjunctivitis (ocular allergy symptoms).
At a glance
| Generic name | Bilastine Ophthalmic Solution 0.6% |
|---|---|
| Sponsor | Faes Farma, S.A. |
| Drug class | Selective H1-receptor antagonist (antihistamine) |
| Target | H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology / Allergy |
| Phase | Phase 3 |
Mechanism of action
Bilastine competitively antagonizes H1 histamine receptors on mast cells and other immune cells in ocular tissues, preventing histamine release and reducing allergic inflammation. When formulated as an ophthalmic solution, it provides local anti-allergic and antihistamine effects to relieve ocular allergy symptoms including itching, redness, and tearing.
Approved indications
- Allergic conjunctivitis (ocular allergy symptoms)
Common side effects
- Ocular irritation
- Headache
- Dysgeusia (taste disturbance)
- Conjunctival hyperemia
Key clinical trials
- Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children (PHASE3)
- A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model. (PHASE3)
- A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bilastine Ophthalmic Solution 0.6% CI brief — competitive landscape report
- Bilastine Ophthalmic Solution 0.6% updates RSS · CI watch RSS
- Faes Farma, S.A. portfolio CI