Durysta (bimatoprost implant) / AbbVie - LARVOL DELTA

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

Drugs for open-angle glaucoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Glaucoma • Ophthalmology

Evaluation of Long-Term Safety and Efficacy of One or Two Administrations of 10 µg Intracameral Bimatoprost in Patients with Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (ARVO 2025) - P3 | "Purpose This study evaluated long-term safety and duration of the IOP-lowering effect with 1 or 2 administrations of bimatoprost SR in a phase 3 clinical trial extension (MAIA)...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."

Clinical • Cataract • Dry Eye Disease • Glaucoma • Ophthalmology

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (clinicaltrials.gov) - P2 | N=83 | Completed | Sponsor: Ocular Therapeutix, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Drug Delivery Systems in Glaucoma- Current Innovations and Future Perspectives. (PubMed, Asia Pac J Ophthalmol (Phila)) - "In this manuscript, we summarise the limitations of traditional topical anti-glaucoma therapy and study current drug delivery systems to lower IOP, with focus on the only two that have made FDA-approval- Durysta and iDose TR...We also explore the concept of novel nanoparticle-based drug delivery systems, which have the advantage of being highly modifiable and customisable, able to incorporate large amounts of cargo while maintaining a high transfection efficacy, and at a fraction of the cost. Lastly, we propose that nanomedicine, in conjunction with gene therapy, offers a promising solution to the aforementioned challenges of current glaucoma therapy, and can herald a new era of sustained glaucoma treatment."

Journal • Gene Therapies • Glaucoma • Ophthalmology

Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON). (PubMed, Drugs) - P3 | "In this interim analysis based on available data, the IOP-lowering effect of the initial administration of the 10-µg bimatoprost implant was well maintained for > 1 year in most patients. Results after a second administration were comparable. The safety profile of initial and repeat administration was acceptable."

Clinical • Journal • P3 data • P3 data: top line • Cardiovascular • Glaucoma • Ophthalmology

Prospective 18-Month Study of Bimatoprost Intracameral Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension in US Clinical Practice. (PubMed, Drugs) - P | "The bimatoprost implant helped control IOP and decrease topical medication use. Throughout the 18 months after implant administration, an estimated 77.7% of eyes required no new added medication for IOP management. Patient-reported outcomes were favorable, and the safety profile of the implant was acceptable."

Journal • Cardiovascular • Dry Eye Disease • Glaucoma • Ophthalmology

Prostaglandin Intracameral Implants for Ocular Hypertension and Open-Angle Glaucoma. (PubMed, J Pharm Technol) - "Data synthesis: Bimatoprost and travoprost intracameral implants demonstrated noninferior IOP reduction compared to timolol eye drops in phase 3 trials, with sustained effects up to 12 and 36 months, respectively...The travoprost implant contains a titanium reservoir and requires surgical placement, while the bimatoprost implant is biodegradable and can be placed in a clinic setting... Prostaglandin intracameral implants are a novel approach to reducing medication burden while delivering sustained IOP reducing effects. Pharmacists should be aware of efficacy and safety considerations of these implants relative to available topical treatments for ocular hypertension or open angle glaucoma."

Clinical • Journal • Review • Cardiovascular • Glaucoma • Ophthalmology

Bimatoprost Intracameral Implant (Durysta®): A New Era in Glaucoma Management Through Sustained-Release Innovation. (PubMed, Drug Des Devel Ther) - "Future research should explore its use in advanced glaucomas, cost-effectiveness, and combination with other IOP-lowering treatments. The bimatoprost intracameral implant represents a promising innovation in glaucoma therapy with potential for improved patient outcomes."

Journal • Review • Glaucoma • Ophthalmology

Travoprost Intracameral Implant in Eyes with Glaucoma or Ocular Hypertension: Early Short-Term Real-World Outcomes. (PubMed, Clin Ophthalmol) - "Patients were pseudophakic, had OAG or OHT, and had undergone prior SLT and/or bimatoprost intracameral implant injection (Durysta)...No secondary procedures occurred in any eye. Standalone implantation of the travoprost intracameral implant yielded statistically and clinically significant IOP and medication reductions through 3 months in eyes with prior SLT and/or bimatoprost intracameral implant injection with favorable safety."

Journal • Real-world evidence • Cardiovascular • Glaucoma • Ocular Inflammation • Ophthalmology • Uveitis

Persistent bilateral sclerouveitis following bimatoprost implantation and removal. (PubMed, Am J Ophthalmol Case Rep) - "The persistence and severity of this inflammatory response to bimatoprost implants, despite its removal, highlight the importance of considering patient-specific risk factors and tailoring management accordingly. Clinicians should be prepared for possible severe reactions requiring intervention."

Journal • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 µg and Selective Laser Trabeculoplasty. (PubMed, Am J Ophthalmol) - P3 | "The bimatoprost implant demonstrated statistical and clinical noninferiority to SLT in IOP reduction from baseline at weeks 4, 12, and 24. In subgroup analysis, patients with flexible implant readministration met the same criteria. Both the implant and SLT demonstrated sustained (2-year) IOP lowering in many eyes. A flexible administration schedule improved the safety profile of the implant over the fixed administration schedule."

Journal • P3 data • Cardiovascular • Glaucoma • Ophthalmology

New treatments for glaucoma. (PubMed, Curr Opin Ophthalmol) - "Glaucoma treatment has considerably evolved over the last decade with the introduction of novel topical medications, minimally invasive glaucoma surgeries, sustained-release drug delivery systems, and wearable devices. This expansion in glaucoma has enabled more patient-centric decision-making regarding treatment."

Journal • Glaucoma • Ophthalmology

A New Analytical Method for Quantifying Acid-End-Cap PLGA in Sub-Milligram Quantities. (PubMed, Mol Pharm) - "It is noted that the existing analytical methods may not be able to separate and quantify PLGA polymers when used as a mixture in a drug product (e.g., Durysta and Ozurdex). This new approach provides another powerful tool for characterizing PLGA polymers in FDA-approved drug products. This is especially significant considering that the PLGAs of commercial products are likely to have molecular properties different from those of the raw PLGAs before going through the manufacturing process."

Journal

Tigris: Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution (clinicaltrials.gov) - P1/2 | N=201 | Active, not recruiting | Sponsor: SpyGlass Pharma, Inc. | Recruiting ➔ Active, not recruiting | N=140 ➔ 201

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Cataract • Glaucoma • Ophthalmology

Mobile bimatoprost implant requiring surgical extraction. (PubMed, J Fr Ophtalmol) - No abstract available

Journal

New Trents In Eye Care In Bahrain Most Recent Advances In Our Daily Eye Care Practice (ESCRS 2024) - "Purpose: This Abstract Explores The Integration Of New Trends In Ophthalmic Practice, Encompassing The Use Of Vuity Eye Drops, Tyrvaya Nasal Spray, Durysta, Cxl Unbound, Light Adjustable Lenses, Capsulaser, And Tepezza... Doing bilateral eye surgey whether refractive, ICL, or cataract surgery under topical anaesthesia as a day case have tremendous benefits to the patients and increased turnover of patients in eye care establishments in Bahrain."

Cataract • Ophthalmology • Strabismus