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Bilastine Ophthalmic Solution 0.6% — Competitive Intelligence Brief
phase 3
Selective H1-receptor antagonist (antihistamine)
H1 histamine receptor
Ophthalmology / Allergy
Small molecule
Live · refreshed every 30 min
Target snapshot
Bilastine Ophthalmic Solution 0.6% (Bilastine Ophthalmic Solution 0.6%) — Faes Farma, S.A.. Bilastine is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the eye.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Bilastine Ophthalmic Solution 0.6% TARGET | Bilastine Ophthalmic Solution 0.6% | Faes Farma, S.A. | phase 3 | Selective H1-receptor antagonist (antihistamine) | H1 histamine receptor | |
| Azelastine - intranasal application | Azelastine - intranasal application | Association Asthma, Bulgaria | marketed | Selective H1-receptor antagonist (intranasal antihistamine) | H1 histamine receptor | |
| Antihistamine Cetirizine Hydrochloride | Antihistamine Cetirizine Hydrochloride | Goldman, Butterwick, Fitzpatrick and Groff | marketed | H1-receptor antagonist (second-generation antihistamine) | H1 histamine receptor | |
| Ciclesonide & Levocetirizine | Ciclesonide & Levocetirizine | Handok Inc. | marketed | Inhaled corticosteroid + selective H1-receptor antagonist combination | Glucocorticoid receptor (ciclesonide); H1 histamine receptor (levocetirizine) | |
| Atarax (Hydroxyzine) | Atarax (Hydroxyzine) | University Hospital, Toulouse | marketed | First-generation H1 antihistamine | H1 histamine receptor | |
| diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan | diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan | Montefiore Medical Center | marketed | Combination cold/cough/allergy remedy | H1 histamine receptor (diphenhydramine); alpha-1 adrenergic receptor (phenylephrine); NMDA receptor and sigma-1 receptor (dextromethorphan) | |
| Diphenhydramine 5% | Diphenhydramine 5% | Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology | marketed | H1 receptor antagonist (first-generation antihistamine) | H1 histamine receptor |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Selective H1-receptor antagonist (antihistamine) class)
- Faes Farma, S.A. · 2 drugs in this class
- ORA, Inc. · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Bilastine Ophthalmic Solution 0.6% — Competitive Intelligence Brief. https://druglandscape.com/ci/bilastine-ophthalmic-solution-0-6. Accessed 2026-05-16.
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