Bimatoprost Implant: First Approval

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ADISINSIGHT REPORT

Bimatoprost Implant: First Approval Matt Shirley1

© Springer Nature Switzerland AG 2020

Abstract Bimatoprost implant (Durysta™), developed by Allergan, is a sustained-release drug delivery system containing bimatoprost, a prostaglandin analogue with ocular hypotensive activity. The implant, administered intracamerally, involves the use of a biodegradable, solid polymer drug delivery system for slow, sustained drug release, designed to lower intraocular pressure (IOP) over a 4- to 6-months period. In March 2020, bimatoprost implant received its first approval, in the USA, for use to reduce IOP in patients with open angle glaucoma (OAG) or ocular hypertension (OHT). Allergan’s clinical development programme for bimatoprost implant is ongoing. This article summarizes the milestones in the development of bimatoprost implant leading to this first approval for use in the reduction of IOP in patients with OAG or OHT.

Bimatoprost Implant (­ DurystaTM): Key Points  A biodegradable sustained-release intracameral implant containing the prostaglandin analogue bimatoprost Developed by Allergan, bimatoprost implant received its first approval on 04 March 2020, in the USA Approved for use to reduce IOP in patients with open angle glaucoma or ocular hypertension

1 Introduction Open-angle glaucoma (OAG) is a chronic and progressive eye disorder that is characterized by optic nerve damage and is commonly associated with elevated intraocular pressure Enhanced material  for this AdisInsight Report can be found at: https​://doi.org/10.6084/m9.figsh​are.12269​417 This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Matt Shirley [email protected] 1



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(IOP) [1, 2]. In OAG, disease progression leads to irreversible visual field loss and, if untreated, can result in blindness. Management of OAG centres around the use of medications, laser trabeculoplasty or surgery (or a combination of the three) to lower IOP with the aim of preventing or slowing vision loss. First-line treatment for OAG usually involves the use of topical IOP-lowering medications, most commonly prostaglandin analogues (e.g. bimatoprost, latanoprost, tafluprost, travoprost). Other classes of topical IOP-lowering medications used for the treatment of OAG include cholinergic agonists (e.g. pilocarpine), β-adrenergic receptor blockers (e.g. timolol), α-adrenergic receptor agonists (e.g. brimonidine) and carbonic anhydrase inhibitors (e.g. brinzolamide) [1, 2]. Although topical medications are generally efficacious in lowering IOP, adherence issues frequently complicate disease management [3–6]. Factors reported to negatively impact adherence to topical IOP-lowering medications include a poor understanding of the disease, poor self-efficacy, difficulty in eye drop administration, forget