Brimo PS DDS (brimonidine intravitreal implant) / AbbVie - LARVOL DELTA

Intravitreal Brimonidine Drug delivery system (DDS) slows optic nerve degeneration in a non-human primate model of experimental glaucoma (ARVO 2023) - "Clinically, topical brimonidine reduced visual field progression in low tension glaucoma patients more effectively than timolol despite similar intraocular pressure (IOP) lowering effects. Our objective was to evaluate the neuroprotective efficacy of intravitreal Brimonidine DDS in a non-human primate (NHP) model of glaucoma...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Glaucoma • Ocular Inflammation • Ophthalmology • Optic Neuritis

Deep Learning Guided Quantification of Retinal Nerve Fiber Layer in a Non-Human Primate Model of Experimental Glaucoma (ARVO 2023) - "Methods SD- OCT (Spectralis HRA + OCT) images from 24 cynomolgus monkeys induced with unilateral experimental glaucoma were dosed with either of the three test articles (n=8): Sham, Brimonidine DDS high dose (200 ug), and Brimonidine DDS low dose (67 ug)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Preclinical • Glaucoma • Ophthalmology

Randomized Phase 2b Study of Brimonidine Drug Delivery System Generation 2 for Geographic Atrophy in Age-related Macular Degeneration. (PubMed, Ophthalmol Retina) - "Multiple intravitreal administrations of Brimo DDS (Gen 2) were well tolerated. The primary efficacy endpoint at 24 months was not met, but there was a numerical trend for reduction in GA progression at 24 months compared with sham treatment. The study was terminated early because of the lower-than-expected GA progression rate in the sham/control group."

Journal • P2b data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Ocular Pharmacokinetics of Brimonidine Drug Delivery System in Monkeys and Translational Modeling for Selection of Dose and Frequency in Clinical Trials. (PubMed, J Pharmacol Exp Ther) - "An intravitreal sustained-release brimonidine implant, Brimonidine Posterior Segment Drug Delivery System (brimonidine DDS), allowing targeted drug delivery to the retina, has been developed for potential clinical application...Targeted retinal brimonidine delivery from vitreous was demonstrated in monkeys. Simulated tissue concentration-time profiles indicated persistence of pharmacologically effective brimonidine concentrations for ≈3 months in human retina."

Clinical • Journal • PK/PD data • Anesthesia • Ophthalmology

A nonhuman primate model of blue light-induced progressive outer retina degeneration showing brimonidine drug delivery system-mediated cyto- and neuroprotection. (PubMed, Exp Eye Res) - "In summary, Brimo DDS demonstrated cyto- and neuroprotective effects in a novel NHP GA model of progressive retinal degeneration. (369 words of 500 max)."

Journal • Preclinical • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

[VIRTUAL] A Retrospective Analysis: Visual Field Progression and Visual Acuity following Administration of Brimonidine Drug Delivery System (ARVO 2021) - "In glaucomatous patients with VF MD below the HFA median, Brimo DDS 264 µg significantly reduced VF loss up to 6 months while providing improvement in vision as early as 1 month."

Retrospective data • Glaucoma • Ophthalmology

Emerging Therapies in Nonexudative Age-Related Macular Degeneration in 2020. (PubMed, Asia Pac J Ophthalmol (Phila)) - "Six upcoming agents have shown results at least in the 2A phase. This includes intravitreal agents that are inhibitors of integrin (Risuteganib), intravitreal agents that disrupt the complement pathway (Zimura, APL-2), neuroprotective implants (Brimonidine DDS), a subcutaneous injectable (Elamipretide), and photobiomodulation (Valeda Light Delivery System)."

Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ophthalmology • Retinal Disorders

Allergan solidifies strong footprint at ARVO 2017 with several data presentations (Allergan Press Release) - "Allergan...announced today that  23 Allergan-supported abstracts were selected for poster presentations at the Annual Meeting of the Association of Research in Vision and Ophthalmology...Brimonidine Drug Delivery System...Slows the Growth of Retinal Pigment Epithelial Hypofluorescence Following Regional Blue Light Irradiation on a Nonhuman Primate (NHP) Model of Geographic Atrophy...Brimonidine Drug Delivery System (DDS) Generation 1 in Patients with Geographic Atrophy: Post-hoc Analysis of a Phase 2 Study."

Clinical data • Age-related Macular Degeneration • Dry Eye Disease • Ophthalmology

2020’s Potential Retina Milestones - "A pivotal trial in nAMD and a Phase 2 trial of the suprachoroidal drug-delivery platform are on deck for RGX-314 gene therapy for nAMD. Investigator Jeffrey S. Heier, MD, reported Phase 1/2A results that showed treated patients averaged 2.6 intravitreal injections over 12 months. In later cohorts, five of 12 and eight of 11 patients were free of intravitreal injections at six months."

Review

Allergan to showcase continued eye care innovation with new data at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (Allergan Press Release) - "Allergan plc...will present new data at the Annual Meeting of The Association for Research in Vision and Ophthalmology (ARVO) to be held in Vancouver, British Columbia from April 28th - May 2nd. Data will include three paper presentations on the company's ophthalmology pipeline including new findings evaluating Abicipar in patients with neovascular age-related macular degeneration (nAMD) and Brimonidine Drug Delivery System (DDS) in patients with geographic atrophy secondary to age-related macular degeneration (AMD)."

P1/2 data • P2b data • P3 data

Allergan reports fourth quarter and full-year 2018 financial results (PRNewswire) - "...Brimonidine DDS for geographic atrophy secondary to age-related macular degeneration. Allergan plans to initiate Phase 3 clinical trials in the second half of 2019."

New P3 trial