Fumena (vorolanib) / Tyrogenex, Betta Pharma - LARVOL DELTA

Beyond the injection: delivery systems reshaping retinal disease management. (PubMed, Expert Opin Pharmacother) - "Specific innovations discussed include the ranibizumab port delivery system, EYP-1901 (Duravyu, vorolanib implant), KSI-301 (tarcocimab tedromer), KSI-501, OTX-TKI (Axpaxli, axitinib implant), 4D-150, revakinagene taroretcel-lwey (Encelto, NT-501, encapsulated cell therapy), Xipere (triamcinolone acetonide injectable suspension), AU-011 (belzupacap sarotalocan targeted delivery), ABBV-RGX-314, elamipretide, and OCS-01 (high concentration dexamethasone)...Challenges include overcoming the blood-retinal barrier, surgical complications with implantable devices, and ensuring patient adherence. Advances in smart delivery systems, drug formulations, and predictive models, alongside interdisciplinary collaboration, will be crucial in achieving personalized, effective, and sustainable retinal therapies."

Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders

Target and selectivity profiling of axitinib in cell-based and biochemical assays (ARVO 2025) - "Additionally, cell-based and radiometric kinase assays (33PanQinaseTM) were conducted at Reaction Biology, Germany, to evaluate half-maximal inhibitory concentration (IC50) of axitinib and vorolanib on VEGFR, PDGFR, FGFR, and TIE2 kinase activity with sunitinib as positive control. 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."

Ophthalmology • FGFR • FLT1 • FLT4 • KDR • PDGFRA • PDGFRB

PAVIA phase 2 trial of EYP-1901 in nonproliferative diabetic retinopathy: 12-month results (ARVO 2025) - P2 | "EYP-1901 includes a bioerodible intravitreal insert for sustained-delivery of vorolanib, a pan-vascular endothelial growth factor receptor inhibitor, for ≥6 months. 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."

P2 data • Diabetic Macular Edema • Diabetic Retinopathy • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

12-month interim phase results from a good laboratory practice (GLP) pivotal repeat-dose toxicity study of EYP-1901 (vorolanib intravitreal insert) in Dutch-Belted rabbits (ARVO 2025) - "EYP-1901 has the potential to reduce the treatment burden in patients with wAMD if shown to be safe and effective.This study used Dutch-Belted rabbits to investigate the long-term safety of EYP-1901 with repeat dosing at a range of drug levels, to support use in phase 3 clinical trials. No adverse findings were observed, supportive of safety with repeat dosing.Clinical safety and efficacy of EYP-1901 will be assessed in the phase 3 trials LUGANO and LUCIA, enrolling patients globally with wAMD."

Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Assessment of treatment burden in wet age-related macular degeneration treated with EYP-1901 (vorolanib intravitreal insert) versus aflibercept: DAVIO 2 trial results (ARVO 2025) - P2 | "All patients in DAVIO 2 had been treated for wet AMD before the trial.In DAVIO 2, 63% of EYP-1901-treated eyes did not need any additional aflibercept treatment to control their disease up to 6 months after receiving EYP-1901, with half of patients receiving their first supplemental treatment ~9-10 months after EYP-1901. Overall, this was an ~80% reduction in treatment burden versus how often these patients were treated before the trial, and 70% reduction versus patients receiving standard-of-care treatment during the trial."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

LUGANO and LUCIA trial design: Pivotal phase 3 studies of EYP-1901 vs aflibercept in wet age-related macular degeneration (ARVO 2025) - P2, P3 | "EYP-1901 provides sustained-release of the tyrosine kinase inhibitor, vorolanib, that acts as a selective pan-vascular endothelial growth factor receptor inhibitor...The phase 3 trials LUGANO and LUCIA will compare EYP-1901 given as an injection into the eye every 6 months versus the standard of care, aflibercept 2.0 mg (Eylea) given as an injection into the eye every 8 weeks...At each monthly visit, patients will be assessed to determine if supplemental treatment with aflibercept 2.0mg is needed to control their disease.The main objective of the study is to assess whether patients' vision after one year of EYP-1901 treatment is similar to vision of patients treated with aflibercept. Other objectives include determining if patients who received EYP-1901 required fewer injections and how safe the treatment is."

P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

VORSIN-RCC: Vorolanib plus sintilimab for advanced renal cell carcinoma after failure of prior immune checkpoint inhibitors-based combination therapy. (ASCO-GU 2025) - P2 | "A phase Ib/II single-arm trial achieved a high objective response rate (ORR) with lenvatinib plus pembrolizumab in patients post-ICI progression (Lee CH et al., Lancet Oncol 2021)...The failures of previous ICI re-challenges may be related to the limited efficacy of PD-L1 blockade (atezolizumab) in RCC and the reduced dosage of tivozanib, whose efficacy is closely related to its blood concentration...Clinical trial information: NCT06523049. Research Sponsor: Hao Zeng."

Checkpoint inhibition • Combination therapy • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor

VERONA: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=27 | Completed | Sponsor: EyePoint Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Efficacy and Safety of Vorolanib Combined with Toripalimab as First-Line Treatment for Metastatic Clear Cell Renal Cell Carcinoma: A Multicenter, Open-Label Clinical Study (ChiCTR) - P2 | N=60 | Recruiting | Sponsor: Xi'an Jiaotong University Second Affiliated Hospital; Xi'an Jiaotong University Second Affiliated Hospital

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

The study on efficacy and safety of Ensatinib combined with Vorolanib in the treatment of advanced non-small cell lung cancer with ALK positivity and high PD-L1 expression (ChiCTR) - P1/2 | N=49 | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • PD-L1

Vigor: Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Patients: a Single-arm, Prospective, Open-label Phase II Clinical Study (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Li-kun Chen

Metastases • Monotherapy • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vorolanib in the Second-line Treatment of Patients with Unresectable or Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=39 | Recruiting | Sponsor: Jinling Hospital, China

Metastases • New trial • Genito-urinary Cancer • Kidney Cancer • Nephrology • Oncology • Renal Cell Carcinoma • Renal Disease • Solid Tumor • Urethral Cancer • Urology

CA209-982: Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors (clinicaltrials.gov) - P1/2 | N=88 | Completed | Sponsor: Vanderbilt-Ingram Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Apr 2024

Combination therapy • Trial completion • Trial completion date • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer • Thymic Carcinoma • Thymus Cancer • BRAF • EGFR • PD-L1 • ROS1

Role of EYP-1901 in neovascular age-related macular degeneration and diabetic eye diseases: review of Phase I/II trials. (PubMed, Ther Deliv) - "EYP-1901 is integrated with the Durasert drug delivery system to administer a sustained release of vorolanib directly to the posterior segment of the eye. This delivery system ensures a consistent therapeutic effect over an extended period and significantly reduces the frequency of clinical interventions required, offering a more convenient treatment regimen while maintaining patient safety."

Journal • P1/2 data • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Prospective Registry Study of Stereotactic Ablative Radiotherapy (SABR) for Oligometastatic/Oligometastatic Renal Cell Carcinoma (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Metastases • New trial • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

VERONA: Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: EyePoint Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients (clinicaltrials.gov) - P1/2 | N=37 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P1/2 trial • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

CM082 suppresses hypoxia-induced retinal neovascularization in larval zebrafish. (PubMed, Front Pharmacol) - "Our results elucidated that CM082 mediated its therapeutic efficacy primarily through the inhibition of Vegfr2 phosphorylation. The findings demonstrated that CM082 possessed strong antiangiogenic effects and may serve as a potential treatment for angiogenesis in ocular neovascular diseases."

Journal • Age-related Macular Degeneration • Ophthalmology

Vorolanib Plus Sintilimab for Advanced Renal Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitors Based Combination Therapy (clinicaltrials.gov) - P2 | N=67 | Not yet recruiting | Sponsor: Hao Zeng

Checkpoint inhibition • Combination therapy • Metastases • New P2 trial • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Study on the Efficacy and Safety of Vorolanib Combined with Cadonilimab in the Treatment of Untreated Advanced RCC Patients (ChiCTR) - P1/2 | N=37 | Not yet recruiting | Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

New P1/2 trial • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration. (PubMed, Ophthalmol Sci) - P1 | "These preliminary data support ongoing phase II and planned phase III trials to assess efficacy and safety. The author(s) have no proprietary or commercial interest in any materials discussed in this article."

Journal • P1 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Vorolanib, sunitinib, and axitinib: A comparative study of vascular endothelial growth factor receptor inhibitors and their anti-angiogenic effects. (PubMed, PLoS One) - "Vorolanib, sunitinib, and axitinib exhibited pan-VEGFR inhibition and inhibited RTKs associated with pathological angiogenesis. Of the three TKIs, only axitinib potently inhibited TIE2 which is an undesired trait as TIE2 is essential for vascular stability. The findings support the use of vorolanib for therapeutic inhibition of angiogenesis observed in DR, DME, and wAMD."

Clinical • Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase II Clinical Study of Cadonilimab in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Henan Cancer Hospital

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

The DAVIO 2 trial: a phase 2, randomized, double-masked, controlled multicenter study of EYP-1901 vs aflibercept in previously treated wet age-related macular degeneration (ARVO 2024) - "EYP-1901 is a sustained-delivery therapy supplying the pan–vascular endothelial growth factor (VEGF) receptor inhibitor vorolanib in a bioerodible form of the intravitreal Durasert platform that allows consistent delivery for ~9 months in animal models. After 6 months of treatment, a single dose of EYP-1901 with protocol-specified SoC supplementation provided noninferior BCVA to SoC monotherapy for wAMD. The impact of EYP-1901 on treatment burden in DAVIO 2 is also being assessed, and a phase 2 trial in nonproliferative diabetic retinopathy is underway. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P2 data • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Design and function of EYP-1901, a sustained-release platform for retinal/choroidal diseases: pan–vascular endothelial growth factor receptor inhibitor vorolanib in a bioerodible intravitreal insert (ARVO 2024) - "Vorolanib inhibited all VEGFRs in vitro and blocked VEGF-induced angiogenesis more effectively than the anti-VEGF antibody bevacizumab in vivo. EYP-1901 is a maintenance therapy for VEGF-driven ocular diseases that may provide safe, rapid, and durable IVT delivery of a pan-VEGFR inhibitor with no evidence of compromise of vascular stability. EYP-1901 is also being studied in nonproliferative diabetic retinopathy and diabetic macular edema, and a phase 3 trial in wAMD is planned."

Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • KDR