Durysta (bimatoprost implant) / AbbVie - LARVOL DELTA

Sustained-Release Intracameral Prostaglandin Analog Implants for Glaucoma: Comparative Review and Meta-Analysis of Bimatoprost and Travoprost Delivery Systems. (PubMed, J Ocul Pharmacol Ther) - "Sustained-release intracameral prostaglandin implants provide durable IOP reduction while decreasing dependence on topical therapy. Although efficacy differences between travoprost and bimatoprost implants appear modest, their safety profiles differ, particularly regarding corneal endothelial effects. Further long-term comparative studies are warranted."

Journal • Retrospective data • Review • Cardiovascular • Glaucoma • Ophthalmology

MAIA: Long-term Safety and Efficacy Extension Trial of Bimatoprost SR (clinicaltrials.gov) - P3 | N=455 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Omidenepag isopropyl (Omlonti) for glaucoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Glaucoma • Ophthalmology

Evaluation of long-term safety and efficacy post a single 10 µg bimatoprost implant without any rescue or additional implant by Year 3 (Day 1080) (ARVO 2026) - P3 | "Safety evaluation indicated that pseudophakic subjects had lower mean endothelial cell loss (-2.4%) vs phakic (-6.3%) at Year 3. Conclusions Among subjects who did not need rescue or retreatment after a single bimatoprost implant, intraocular pressure control was sustained for up to three years, visual field stability was largely maintained, medication burden was eliminated, and safety outcomes were favorable, with pseudophakic subjects showing less mean endothelial cell loss than phakic subjects."

Clinical • Glaucoma • Ophthalmology

Safety and Durability of Intraocular Pressure Lowering After Bimatoprost Implant Administration: Completed Phase 3b Trial (TRITON) Results (ARVO 2026) - P3 | "Conclusions The median time from a single Bimatoprost SR administration to requiring a second administration of Bimatoprost SR or rescue treatment was > 1 year. IOP lowering effect was well maintained for majority of patients with an acceptable safety profile."

Clinical • P3 data • Dry Eye Disease • Glaucoma • Ophthalmology

Safety and Efficacy of Bimatoprost Implants for Open-Angle Glaucoma: A Systematic Review and Meta-Analysis of Two-Arm Studies (ARVO 2026) - "Conclusions These findings suggest bimatoprost implants effectively reduce IOP in patients with OAG and/or OHT for at least 3 months. The increase in corneal TEAEs presents a potential safety concern relative to topical therapy and SLT, but unchanged BCVA suggests these events may not compromise vision, supporting implants as an option for patients inadequately controlled on first-line treatments."

Retrospective data • Review • Glaucoma • Ophthalmology

Corneal endothelial cell density in patients with extended IOP control after a single bimatoprost implant administration in the TRITON phase 3b study (ARVO 2026) - P3 | "At each yearly timepoint, at least 1 patient in the phakic subgroup and no patient in the pseudophakic subgroup had ≥15% ECL. Conclusions Among patients receiving a single administration of bimatoprost 10 µg implant who had at least 3 years of IOP control without any additional treatment, >15% ECL was observed in the phakic subgroup, but no pseudophakic patient had >15% ECL through 4 years of follow-up."

Clinical • P3 data • Glaucoma • Ophthalmology

Responder rate of a single administration of the Bimatoprost implant (Bim-I) in the TRITON study (ARVO 2026) - P3 | "Conclusions Bim-I had a responder rate of 91.2% with some patients showing a delayed response beyond 60 days after administration. No new safety concerns were identified from the previously reported interim analysis of TRITON."

Glaucoma • Ophthalmology

In Vivo Pharmacokinetic Evaluation of a Seven Days Sustained-Release Bimatoprost Ophthalmic Topical Insert Versus Bimatoprost Eye Drops in Rabbits (ARVO 2026) - "Conclusions A single administration of the sustained-release bimatoprost insert provided equivalent seven-day ocular exposure to daily drops despite a 50% lower total dose. This insert offers a patient-friendly, adherence-independent alternative for intraocular pressure management, with consistent exposure and reduced dosing burden."

PK/PD data • Preclinical • Glaucoma • Ocular Inflammation • Ophthalmology

Use of Bimatoprost Intracameral Implant for the Treatment of Glaucoma: A Focused Narrative Review. (PubMed, Cureus) - "Across phase I/II and phase III trials, bimatoprost implants produced intraocular pressure reductions comparable to topical timolol or topical bimatoprost through early follow-up, and many eyes remained drop-free for months to a year. Corneal adverse events and CECD loss were infrequent after single administration but increased with fixed-interval repeat dosing, with a less favorable profile at higher dose strengths. It was concluded that intracameral bimatoprost implants offer a drop-sparing alternative that may reduce adherence burden, but careful patient selection and monitoring for corneal endothelial effects are central to safe use."

Journal • Review • Cardiovascular • Glaucoma • Ophthalmology

Overview of Intracameral Drug Delivery Systems in Glaucoma. (PubMed, Clin Ophthalmol) - "This review aims to provide clinicians with an overview of the design, clinical performance, and key considerations of the two FDA-approved intracameral implants, Durysta® (BimSR) and iDose® TR (iDose), as well as investigational devices including ENV515, OTX-TIC, and PA5108. In addition, randomized comparative studies evaluating intracameral DDSs against other glaucoma interventions, such as minimally invasive glaucoma surgery (MIGS), are scarce. Intracameral DDSs represent a developing area within glaucoma management, and further evidence is needed to clarify their long-term safety and their appropriate role within personalized treatment strategies."

Journal • Review • Glaucoma • Ophthalmology

Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use (clinicaltrials.gov) - P4 | N=20 | Recruiting | Sponsor: University of Miami | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Cardiovascular • Glaucoma • Ophthalmology

Computational study of Durysta® implant for glaucoma treatment: drug dispersion and aqueous humor flow in the anterior chamber. (PubMed, Drug Deliv Transl Res) - "In the early phase, high concentration zones appear near the implant, while long-term simulations demonstrate sustained and uniform drug distribution throughout the AC. These findings advance the understanding of sustained intraocular drug delivery and establish a computational framework to guide the optimization of future implant designs, aiming to improve therapeutic outcomes in glaucoma management."

Journal • Glaucoma • Ophthalmology

Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. (PubMed, Ophthalmol Ther) - P, P=N/A | "The first human study of a novel system that mounts bimatoprost-infused pads to a single-piece IOL suggests favorable safety and efficacy and does not require additional surgical skills beyond routine cataract surgery. A larger sample with comparative data is necessary to further assess effects."

First-in-human • Journal • Cardiovascular • Cataract • Dry Eye Disease • Glaucoma • Hematological Disorders • Ophthalmology

Implants to Treat Glaucoma: Promising or Not? (PubMed, Drugs Aging) - "The biodegradable bimatoprost implant releases the drug continuously for 4-6 months, and its effect on IOP may extend for up to 2 years in 25% of patients. The non-biodegradable intracameral implant releases travoprost for 36 months, when it needs to be removed...Several other biodegradable intracameral implants that release prostaglandin analogues are undergoing clinical trials. In the future, intraocular implants containing genetically modified cells that secrete neurotrophic factors may potentially offer an IOP-independent neuroprotective strategy, complementing existing IOP-lowering implants in glaucoma management."

Journal • Review • Glaucoma • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain

Retrospective Single-Center Outcomes After a First Bimatoprost Sustained-Release Implant. (PubMed, Clin Ophthalmol) - "The implant provided six months of freedom from additional IOP lowering interventions in more than half of the eyes with an expected decline. A small group continued to be free from additional IOP lowering intervention for up to 24 months."

Journal • Retrospective data • Glaucoma • Ophthalmology

Expert Opinion to Optimize Clinical Outcomes of Bimatoprost Intracameral Implant Treatment. (PubMed, Clin Ophthalmol) - "Recommendations regarding the administration procedure and patient follow-up are provided. The objective of this expert opinion is to help optimize patient selection for Bim-I administration, the implantation procedure, follow-up management, and clinical outcomes while minimizing and addressing potential complications."

Clinical data • Journal • Cardiovascular • Glaucoma • Ophthalmology

Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine) (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: SpyGlass Pharma, Inc.

New P3 trial • Cardiovascular • Cataract • Glaucoma • Ophthalmology

Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone) (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: SpyGlass Pharma, Inc.

New P3 trial • Cardiovascular • Cataract • Glaucoma • Ophthalmology

Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: University of Miami

Biomarker • New P4 trial • Cardiovascular • Glaucoma • Ophthalmology

Durysta pellet occlusion of XEN gel stent. (PubMed, Am J Ophthalmol Case Rep) - No abstract available

Journal

Evaluation of the Safety and Effectiveness of the Bimatoprost Implant System / IOL Combination in Patients With Ocular Hypertension or Mild to Moderate Open-angle Glaucoma (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: SpyGlass Pharma, Inc.

New trial • Cardiovascular • Cataract • Glaucoma • Ophthalmology

Observational Study to Evaluate Long Term Outcomes for Ocular Hypertension and Glaucoma Patients Treated With the SpyGlass Bimatoprost Implant System / IOL Combination (clinicaltrials.gov) - P=N/A | N=23 | Active, not recruiting | Sponsor: SpyGlass Pharma, Inc.

New trial • Cardiovascular • Cataract • Glaucoma • Ophthalmology

MAIA: Long-term Safety and Efficacy Extension Trial of Bimatoprost SR (clinicaltrials.gov) - P3 | N=455 | Active, not recruiting | Sponsor: AbbVie | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Glaucoma • Ophthalmology

TRITON: Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3 | N=515 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology