192024-041D Bimatoprost PF Intracameral Drug Delivery System

• Research type

  Research Study

• Full title

  A Multicenter, Paired-eye Comparison, Dose-escalation, Single Dose, 24-Month Study of Safety and Efficacy of Bimatoprost Preservative Free Intracameral Drug Delivery System (Bimatoprost PF IC DDS) in Patients With Open-Angle Glaucoma

• IRAS ID

  98544

• Contact name

  Nicholas Strouthidis

• Sponsor organisation

  Allergan Limited

• Eudract number

  2011-005091-42

• Clinicaltrials.gov Identifier

  NCT01157364

• Research summary

  Bimatoprost (ophthalmic solution -LUMIGAN©) is a well-established effective therapy, for lowering eye pressure inside the eye in patients who have glaucoma (a group of diseases characterized by increased eye pressure and damage to the optic nerve) and high eye pressure (Ocular Hypertension). A sustained-release Intracameral Drug Delivery System Applicator System was developed at Allergan to evaluate anti-hypertensive therapies for the eye that do not require patient self-administration. The Bimatoprost PF IC DDS (preservative free intracameral drug delivery system) refers to the biodegradable preservative-free bimatoprost sustained-release implant. The implant contains total preservative-free bimatoprost loads of 6 æg ,10 æg, 15 æg, or 20 æg to provide an average daily release (as determined by in vitro studies) of approximately 70, 110, 170 or 220 ng, respectively, over an approximately 3 month duration in the intracameral space (ie, anterior chamber of the eye). In contrast, a 35 æl drop of LUMIGAN (bimatoprost ophthalmic solution) 0.03% typical of what is used clinically to reduce eye pressure, contains approximately 10 æg of bimatoprost. With topical therapy, a patient would have drug exposure to the ocular surface totaling ~900 æg over 3 months. Reducing the total daily drug exposure to the eye by up to ~48 fold with the Bimatoprost PF IC DDS, and delivering the drug directly to the aqueous humor avoiding the eyelids and conjunctiva, may reduce the adverse effects observed with topical LUMIGAN. The Bimatoprost PF IC DDS is injected into the anterior chamber near the corneal limbus through a pre-filled applicator system. The biodegradable polymer matrix slowly degrades so that there is no need to remove the implant once the drug has been released. The approximate duration of the study for each patient is 25 months (screening duration of -42 to -4 days before injection [day 1], plus visits up to 24 months post-injection). Patients with glaucoma or ocular hypertension meeting all the inclusion criteria and none of the exclusion criterion will be considered for entry into this study. Eligible patients in each cohort will receive on Day 1, an intracameral injection of a Bimatoprost PF IC DDS in the study eye. The patients will be masked to the dose they receive. The fellow eye will receive topical LUMIGAN eye drops, once daily in the evening for the entire duration of the study.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0355

• Date of REC Opinion

  30 May 2012

• REC opinion

  Further Information Favourable Opinion