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bimatoprost solution 0.03 %
bimatoprost solution 0.03 % is a Prostaglandin F analog Small molecule drug developed by Allergan. It is currently in Phase 3 development for Open-angle glaucoma, Ocular hypertension, Hypotrichosis of the eyelashes. Also known as: LATISSE®.
Bimatoprost is a prostaglandin F analog that binds to prostaglandin F receptors to increase uveoscleral outflow of aqueous humor, thereby reducing intraocular pressure.
Bimatoprost solution 0.03% is a small molecule that acts as a prostaglandin F2-alpha receptor agonist. It is used to treat conditions such as Eyelash Hypotrichosis, Open-Angle Glaucoma, and Ocular Hypertension.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | bimatoprost solution 0.03 % |
|---|---|
| Also known as | LATISSE® |
| Sponsor | Allergan |
| Drug class | Prostaglandin F analog |
| Target | Prostaglandin F receptor (FP receptor) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Bimatoprost mimics the action of prostaglandin F by activating F-prostanoid receptors in the eye. This activation enhances drainage of fluid (aqueous humor) through the uveoscleral pathway, the primary drainage route in the eye. The resulting decrease in intraocular pressure helps prevent or slow optic nerve damage and vision loss in glaucoma and ocular hypertension.
Approved indications
- Open-angle glaucoma
- Ocular hypertension
- Hypotrichosis of the eyelashes
Common side effects
- Conjunctival hyperemia (redness)
- Iris pigmentation increase
- Eyelash growth (hypertrichosis)
- Eye irritation/discomfort
- Periocular skin pigmentation
Key clinical trials
- Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma (PHASE4)
- Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata (PHASE1, PHASE2)
- Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension (PHASE3)
- Topical Bimatoprost for Chemical Blepharoplasty (EARLY_PHASE1)
- Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose (PHASE4)
- Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension (PHASE1, PHASE2)
- Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis (PHASE3)
- Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis (PHASE3)
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:
- bimatoprost solution 0.03 % CI brief — competitive landscape report
- bimatoprost solution 0.03 % updates RSS · CI watch RSS
- Allergan portfolio CI
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Related
- Drug class: All Prostaglandin F analog drugs
- Target: All drugs targeting Prostaglandin F receptor (FP receptor)
- Manufacturer: Allergan — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Open-angle glaucoma
- Indication: Drugs for Ocular hypertension
- Indication: Drugs for Hypotrichosis of the eyelashes
- Also known as: LATISSE®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing