bimatoprost ophthalmic (T4032) / Thea Laboratories - LARVOL DELTA

Efficacy and Safety of Preservative-Free Bimatoprost 0.01% Gel in Patients with Open-Angle Glaucoma and Ocular Hypertension: Results from Two Phase III Randomized Trials. (PubMed, Clin Ophthalmol) - "To evaluate the efficacy and safety of preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01%) compared with BAK-preserved bimatoprost ophthalmic solution 0.01% (PB 0.01%) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). There was a numerical trend in favor of PFB 0.01% in terms of presence of conjunctival hyperemia and CFS at Week 6 and Week 12. This pooled analysis of nearly 1000 patients confirmed the efficacy and safety outcomes observed in the individual Phase III pivotal studies, supporting the clinical use of preservative-free bimatoprost 0.01% in the management of glaucoma and OHT."

Journal • P3 data • Cardiovascular • Glaucoma • Ophthalmology

Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients (clinicaltrials.gov) - P3 | N=684 | Completed | Sponsor: Laboratoires Thea | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients (clinicaltrials.gov) - P3 | N=684 | Active, not recruiting | Sponsor: Laboratoires Thea | Recruiting ➔ Active, not recruiting | N=500 ➔ 684 | Trial completion date: Aug 2023 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Glaucoma • Ophthalmology

Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Laboratoires Thea | Not yet recruiting ➔ Completed

Trial completion

Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Laboratoires Thea

New P1 trial

Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Laboratoires Thea | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Glaucoma • Ophthalmology

Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Laboratoires Thea

New P3 trial • Glaucoma • Ophthalmology