NDAOPHTHALMICGEL1 Generic Approved
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
4/8 — Partial
ZOLYMBUS (bimatoprost) by Thea Pharma. Approved for prostaglandin analog [epc]. First approved in 2025.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLYMBUS (bimatoprost) is a prostaglandin analog ophthalmic gel approved by the FDA in September 2025 for treating elevated intraocular pressure. It works by binding prostaglandin receptors to increase uveoscleral outflow of aqueous humor, reducing IOP in glaucoma and ocular hypertension patients. The gel formulation offers an alternative delivery mechanism within the established prostaglandin analog class.
Launch10.0 years to LOE
Early-stage launch product with moderate competitive pressure (15) suggests a focused commercial team building market access and physician adoption.
Mechanism of Action
Pharmacologic Class:
Prostaglandin Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
Started Feb 2023
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients
Started Jun 2022
18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)
Started Mar 2021
220 enrolled
Open-angle GlaucomaOcular Hypertension
A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension
Started Jun 2020
37 enrolled
Open-Angle GlaucomaOcular Hypertension
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Started Mar 2019
455 enrolled
Open-Angle GlaucomaOcular Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.