Opsiria (sirolimus) / Santen, MacuSight - LARVOL DELTA

Performance of a novel Sirolimus eluting balloon in peripheral arterial disease - first report of 6 months results from the SUCCESS PTA study (CIRSE 2024) - "The results on the full cohort at 6 months follow-up will be available by the time of the presentation. This is the first report on the largest cohort treated with SELUTION SLM up to date. Earlier, data from a subset of 321 patients at the 6-month follow-up had been presented, confirming the safety and effectiveness of SELUTION SLR in addressing peripheral arterial disease among real-world patients."

Clinical • Cardiovascular • Peripheral Arterial Disease

SELUTION4BTK - a randomized clinical trial evaluating SELUTION SLR Sirolimus-eluting balloon in the treatment of below-the-knee lesions in patients with chronic limb threatening ischemia (CIRSE 2024) - "SELUTION4BTK trial is currently enrolling in US and Europe. A review of previous data of SELUTION SLR in CLI patients and the unique design of the study will be presented. The innovative design tailored to address historical limitations, coupled with the utilization of the novel SELUTION SLR device, holds the promise of a transformative impact on the treatment of BTK lesions."

Clinical • Cardiovascular • Peripheral Arterial Disease

Tear biomarkers of topical sirolimus treatment in a randomized trial of meibomian gland dysfunction (ARVO 2024) - "The inhibition of mTOR signaling pathway in MGD patients was confirmed after administration of the sirolimus ophthalmic suspension and ATP6V1D was suggested to be a pharmacodynamic biomarker for sirolimus."

Biomarker • Clinical • Ophthalmology • ATP6V1D

SAVE-2: Intravitreal Sirolimus as Therapeutic Approach to Uveitis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Stanford University | N=30 ➔ 0 | Trial completion date: Dec 2022 ➔ Dec 2024 | Recruiting ➔ Withdrawn | Trial primary completion date: May 2022 ➔ Sep 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Ocular Inflammation • Ophthalmology • Uveitis

Emerging Liver Literature Club (AASLD) - "Article #3 - 'Three-Year Results of Renal Function in Liver Transplant Recipients on Low-dose Sirolimus and Tacrolimus: A Multicenter, Randomized, Controlled Trial'..."

Live event

Pharmacy Forum (Oncology Times) - Monday, February 20, 2023.

Forum

SurModics announces 12 months clinical data from SWING trial presented at VEITHsymposium (Pharmabiz) - "'Patient-reported outcome measures have continued to improve from baseline throughout the first 12 months for our modified intent to treat subject population,' said SWING Trial co-lead investigator Professor Ramon Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi). 'The SWING Trial demonstrates that the Sundance Sirolimus DCB has tremendous promise and warrants evaluation in a large-scale pivotal trial.'"

Media quote

SWING trial 12-month data: Novel sirolimus DCB shows “great promise” in “challenging” CLTI population (vascularnews) - "Varcoe added that, 'pleasingly,' the team also saw improvement in Rutherford Becker classification, which was sustained and improved out to 12 months. Regarding quality of life, he noted that patient-reported outcome measures were again consistently improved out to that 12-month endpoint. In closing, Varcoe shared his belief that the Sundance device has 'great promise' and 'warrants evaluation in a large-scale pivotal trial' based on these latest findings."

Media quote

LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye (clinicaltrials.gov) - P3 | N=146 | Terminated | Sponsor: Santen Inc. | Recruiting ➔ Terminated; Business decision

Trial termination • Ocular Inflammation • Ophthalmology • Uveitis

Pharmacy Forum (Oncology Times) - Monday, August 22, 2022.

Forum

MedAlliance SELUTION SLR Receives Second FDA IDE Approval (Yahoo News) - "'We are very excited that US patients suffering from PAD will have the opportunity to receive this novel sirolimus drug coated balloon technology. This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly,' Dr Adams commented."

Media quote • Regulatory

Pharmacy Forum (Oncology Times) - "Wednesday, July 20, 2022, Sirolimus Protein-Bound Particles."

Forum

Bishop Reviews Risk Assessment and Treatment for GVHD (Targeted Oncology) - "Michael R. Bishop, MD, discussed a patient with graft-versus-host disease who first underwent a myeloablative conditioning regimen and peripheral blood stem-cell matched hematopoietic cell transplant as treatment....GVHD develops in 3 phases as was described by the work of James L. Ferrara, MD, who has been a leader in our understanding of the biology of acute GVHD....A paper published by John E. Levine, MD, and his colleagues from the University of Michigan looked at a combination of different molecular markers and cytokines, and were able to demonstrate that, based upon this, they could stratify patients into high-risk and low-risk GVHD."

Media quote

Advanced NanoTherapies Closes Series A Financing to Support FIH Clinical Study of SirPlux Duo DCB - "'Sirolimus and paclitaxel are both proven drugs in the vascular space, each with unique benefits, limitations, and mechanisms of action,' commented Dr. Shishehbor in the company's press release. 'Preclinical data has shown that using both drugs in combination results in higher antiproliferative potency at lower doses than using each drug independently. The synergistic effects of eluting them simultaneously over long periods may be the key to sustaining patency following interventions.'"

Media quote

Advanced NanoTherapies closes Series A funding round (Cardiovascular news) - "'Sirolimus and paclitaxel are both proven drugs in the vascular space, each with unique benefits, limitations, and mechanisms of action,' commented Mehdi Shishehbor...'Pre-clinical data have shown that using both drugs in combination results in higher antiproliferative potency at lower doses than using each drug independently. The synergistic effects of eluting them simultaneously over long periods may be the key to sustaining patency following interventions.'"

Media quote

Advancements in cGVHD Yield New and Anticipated Treatment Options (Oncology Nursing News) - "Chronic graft-versus- host disease (cGVHD) management has advanced greatly in recent years. Not only have experts gained valuable insight into the pathophysiology of the disease, but new treatment modalities continue to be better understood, explained Daniel R. Couriel, MD, MS, in a presentation as part of the 2021 Society of Hematologic Oncology (SOHO) Annual Meeting."

Media quote

SAVE-2: Intravitreal Sirolimus as Therapeutic Approach to Uveitis (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Stanford University; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: May 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Immune Modulation • Ocular Inflammation • Ophthalmology • Uveitis

Moving Forward in the Management of Acute GvHD: Phase III REACH2 Study Overview (Targeted Oncology) - P3, N=NA; REACH2 (NCT02913261); Sponsor: Novartis Pharmaceuticals; "A discussion on decision factors for switching to and deciding upon a second-line therapy, and an overview of the phase 3 REACH2 study with ruxolitinib for glucocorticoid-refractory acute graft-vs-host disease (GVHD)."

P3 data • Video

Sirolimus-Loaded Intravitreal Implant for Effective Treatment of Experimental Uveitis. (PubMed, AAPS PharmSciTech) - "According to these results, the SRL-PLGA implant evaluated in this study was apparently safe, reducing inflammation in treated eyes, with an extended effect possibly associated with prolonged release of SRL in the posterior segment of the eye. Therefore, intravitreal SRL-PLGA implant could be a promising alternative for treatment of non-infectious uveitis."

Journal • Complement-mediated Rare Disorders • Immune Modulation • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis • MPO

Efficacy and Safety of Intravitreal Sirolimus for Noninfectious Uveitis of the Posterior Segment: Results from the Sirolimus Study Assessing Double-Masked Uveitis Treatment (SAKURA) Program. (PubMed, Ophthalmology) - "Intravitreal sirolimus 440 μg improved ocular inflammation, as measured by VH, compared with the 44-μg dose, with minimal impact on IOP, while preserving BCVA."

Clinical • Journal • Complement-mediated Rare Disorders • Dry Eye Disease • Immunology • Ocular Inflammation • Ophthalmology • Uveitis

Sirolimus shows promise for posterior segment non-infectious uveitis (YouTube) - https://www.youtube.com/watch?v=JYjmm2tv_ZM

Video • Ophthalmology

mTOR Inhibition for Noninfectious Uveitis and Beyond: The Evolution of Intravitreal Sirolimus Through Clinical Trials (AAO 2017) - No abstract available.

Clinical • Ocular Inflammation • Ophthalmology

SAKURA: Study Assessing Double-masked Uveitis Treatment (clinicaltrials.gov) - P3; N=592; Completed; Sponsor: Santen Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Complement-mediated Rare Disorders • Immunology • Ocular Inflammation • Ophthalmology

Intravitreal sirolimus effects on oral corticosteriod tapering in subjects with non-infectious uveitis (NIU) of the posterior segment: SAKURA study 1 results (COPHy 2016) - P3, N=347; NCT01358266; Sponsor: Santen; "In SAKURA Study 1, all butone subject who were on oral corticosteroids at baseline were successfully tapered to ≤5 mg/day with intravitreal sirolimus 440 μg."

P3 data • Ocular Inflammation

Long-term safety of intravitreal Sirolimus for the treatment of non-infectious uveitis (NIU) of the posterior segment: 12-month results from SAKURA study 1 (ARVO 2015) - Abstract #5776 - C0237; P3, N=346; "Intravitreal sirolimus was associated with a low incidence of serious ocular adverse events over 12 months in this diverse population of subjects with NIU of the posterior segment. The types of adverse events in the open-label period of SAKURA Study 1 were similar to those observed in the double-masked period."

P3 data • Ocular Inflammation