Durysta (bimatoprost implant) / AbbVie - LARVOL DELTA

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

Third-Generation Trabecular Micro-Bypass In Eyes Failing Prior Surgical And/Or Medical Glaucoma Therapy (ESCRS 2024) - "Most eyes (25/31 or 81%) had undergone one or more prior glaucoma surgery(ies), predominantly Xen, Durysta, and/or laser trabeculoplasty; the remaining eyes were using maximum-tolerated medical therapy (MTMT)... iStent infinite implantation yielded meaningful IOP and med reductions through 9 months in eyes that had failed prior glaucoma surgery(ies) and/or MTMT, with favorable safety."

Cataract • Glaucoma • Ophthalmology

Cystoid Macular Edema Occurring After Intracameral Bimatoprost Implantation (ESCRS 2024) - "The condition resolved following a treatment regimen involving topical dexamethasone and nepafenac. Conclusion/Take home message: The use of bimatoprost implant may lead to the occurrence of CME. Ophthalmologists must vigilantly monitor patients post-implantation, especially if they exhibit visual symptoms or have risk factors for a CME"

Glaucoma • Macular Edema • Ophthalmology

18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA) (clinicaltrials.gov) - P=N/A | N=220 | Completed | Sponsor: Allergan | Recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Bimatoprost SR for Glaucoma Therapy Implanted at the Slit-Lamp in a Real-World Setting. (PubMed, Clin Ophthalmol) - "Adverse events were uncommon and most were transient and resolved with or without intervention. This real-world analysis of bimatoprost SR use for glaucoma therapy complements Phase 3 study findings and demonstrates that the implant can safely provide medication reduction through 6 months in most eyes and through 12 months in almost 40% of eyes."

Journal • Real-world • Real-world evidence • Glaucoma • Ophthalmology

iDose TR - a travoprost implant for glaucoma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Glaucoma • Ophthalmology

Cystoid macular edema occurring after intracameral bimatoprost implantation. (PubMed, Eur J Ophthalmol) - "The use of bimatoprost implant may lead to the occurrence of CME. Ophthalmologists must vigilantly monitor patients post-implantation, especially if they exhibit visual symptoms or have risk factors for a CME."

Journal • Glaucoma • Macular Edema • Ophthalmology

Ocular tolerability and IOP-lowering evaluation of the RTC-620 intracameral implant in normotensive beagle dogs (ARVO 2024) - "A sustained release treatment would improve quality of care.RTC-620 IC Implant is a sustained release implant that provides slow, sustained release of bimatoprost acid... Evaluation in normotensive beagle dogs indicates that the RTC-620 IC Implant is well tolerated following single and repeat-dose administration, with the ability to provide sustained IOP-lowering. These data support the further development of the RTC-620 IC Implant towards first-in-human trials for providing safe repeat treatment for the management of IOP in patients with OHT or OAG. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Glaucoma • Ophthalmology

Safety and longevity of IOP control after bimatoprost implant administration (ARVO 2024) - P3 | "In this interim analysis based on available data, the IOP-lowering effect of the initial bimatoprost implant administration was well maintained for >1 y in the majority of patients, with an acceptable safety profile."

Clinical • Glaucoma • Ophthalmology

Real-world utilization of bimatoprost sustained-release implant (Bimatoprost SR): a retrospective claims-based analysis (ARVO 2024) - "Analysis of real-world claims data indicates that treatment with a single Bimatoprost SR implant reduces topical medication burden and may provide durable IOP control for up to 13 months, based on TTNT findings. Real-world patients receiving Bimatoprost SR implant are typically older and have more severe OAG than patients in the registration trial. Earlier intervention with Bimatoprost SR implant in clinical practice may be appropriate to ensure optimal therapeutic benefit."

Real-world • Real-world evidence • Retrospective data • Glaucoma • Ophthalmology

Safety and IOP outcomes after single administration of 10 µg bimatoprost implant in one eye and SLT in the contralateral eye (ARVO 2024) - P3 | "Bimatoprost implant single administration and SLT both effectively lowered IOP. Both treatments demonstrated similar, favorable safety profiles."

Clinical • Dry Eye Disease • Glaucoma • Keratitis • Ocular Inflammation • Ophthalmology

Psychometric Evaluation of the Allergan Satisfaction with Treatment Experience Questionnaire (ASTEQ) Using Data from a Phase 3B Study of an Intraocular Implant for Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT) (ISPOR 2024) - P3 | "The ASTEQ items are reliable and valid for evaluating satisfaction, bother, and physical discomfort in patients with OAG/OHT receiving bimatoprost implant. While a summary score from the ASTEQ items was not empirically supported, individual items are face-valid assessments and can be used as stand-alone measures, especially for satisfaction and short- and long-term side effects."

P3 data • Cardiovascular • Glaucoma • Ophthalmology

Real-World Analysis of the Efficacy of Bimatoprost Sustained-Release Glaucoma Implant Where American Indians Comprise the Largest Minority Population. (PubMed, Clin Ophthalmol) - "Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled baseline IOP. No clinically meaningful and statistically significant differences in the efficacy of bimatoprost were observed in patients of American Indian descent."

Journal • Real-world • Real-world evidence • Cardiovascular • Glaucoma • Ophthalmology