efdamrofusp alfa (IBI-302) / Innovent Biologics, AP Biosciences - LARVOL DELTA

The Phase 3 Registration STAR Study of Efdamrofusp Alfa (IBI302) Met its Primary Endpoint, Making it the First Self-developed Extended-interval Treatment for nAMD in China (PRNewswire) - "The study met the primary endpoint. At Week 52, the least squares mean estimate (SE) of the mean BCVA change from baseline in the IBI302 8 mg and aflibercept 2 mg groups was 10.37 (0.547) and 10.11 (0.545) ETDRS letters, respectively...Approximately 86% of participants in the IBI302 8 mg group achieved a dosing interval of Q12W or above during the maintenance period; 72.8% of participants achieved a dosing interval of Q16W. At Week 52, approximately 95% of the participants receiving the Q12/16W dosing maintained their interval without requiring retreatment. Furthermore, 56.3% of the participants showed no disease activity at Week 24, demonstrating the potential to extend the dosing interval to Q20W."

P3 data • Age-related Macular Degeneration

An open-label, multicenter, single-arm Phase II clinical study evaluating the efficacy and safety of intravitreal injection of IBI302 in participants with neovascular age-related macular degeneration (ChiCTR) - P2 | N=800 | Not yet recruiting | Sponsor: Shanghai General Hospital; Innovent Biologics Co., Ltd.

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Not yet recruiting ➔ Recruiting

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

Emerging solutions for neovascular age-related macular degeneration. (PubMed, Curr Opin Ophthalmol) - "Therapeutic innovation in nAMD is transitioning from incremental refinements in intravitreal anti-VEGF delivery to strategies aimed at extending durability or targeting alternative contributory pathways. Long-term safety, efficacy, and durability will determine which of these candidates redefine standard care."

Journal • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • FGF2

A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD (clinicaltrials.gov) - P2 | N=800 | Not yet recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy and Safety of Efdamrofusp Alfa with Personalized Dosing Intervals in Neovascular Age-Related Macular Degeneration: A Phase II Trial. (PubMed, Ophthalmol Sci) - "These findings suggested that high-dose IBI302 with extended dosing intervals could provide sustained visual benefits for patients with nAMD. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • P2 data • Age-related Macular Degeneration • Cataract • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efdamrofusp alfa: an insight into the novel drug and its use in age-related macular degeneration. (PubMed, Int J Retina Vitreous) - "Efdamrofusp alfa shows promise as a novel treatment for nAMD, potentially offering improved efficacy over current anti-VEGF therapies. Nonetheless, further large-scale randomized clinical trials are essential to confirm its efficacy and safety in broader populations. The dual-inhibition strategy provides a new avenue for personalized AMD treatment, particularly for patients unresponsive to monotherapies."

Clinical • Journal • Review • Age-related Macular Degeneration • Cardiovascular • Glaucoma • Hematological Disorders • Keratitis • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME） (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Macular Edema • Ophthalmology

Bispecific vs. Bispecific: Innovent Announces First Patient Dosed in the Phase 2 Clinical Study of Efdamrofusp Alfa (IBI302), a First-in-class Anti-VEGF and Anti-Complement Bispecific Fusion Protein for the Treatment of Diabetic Macular Edema (PRNewswire) - "Innovent Biologics...announces the completion of first patient dosing in the Phase 2 clinical study of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, for the treatment of diabetic macular edema (DME). This randomized, double-masked, multi-center, active-controlled Phase 2 clinical study (NCT06908876) aims to evaluate the efficacy and safety of intravitreal injections of efdamrofusp alfa in DME patients. A total of 150 participants will be enrolled and randomized in a 1:1:1 ratio to the IBI302 4 mg group, the IBI302 8 mg group, and the Faricimab (anti-VEGF/ANG-2 bispecific antibody) 6 mg group."

Trial status • Diabetic Macular Edema

Innovent Announces Oral Presentation of Full Phase 2 Clinical Data for Efdamrofusp Alfa (IBI302), First-in-class anti-VEGF/complement Bispecific Fusion Protein at ARVO 2025 (PRNewswire) - P2 | N=132 | NCT05403749 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group....The results showed 6.4 mg/ 8.0 mg IBI302 competitive efficacy and safety profiles:...Throughout the trial period, over 80% of participants in IBI302 groups maintained visual benefits with a 12-week dosing interval....The trial met the primary endpoint, BCVA gains in 6.4mg/8.0mg IBI302 were noninferior to Aflibercept at week 40, the mean change from baseline +10.5[SD 9.6], +11.0[11.4], and +9.8[8.7] ETDRS letters, respectively. This improvement was sustained through week 52 with +10.8 [10.2], +11.3 [10.3], and +10.0 [9.0] letters compared to baseline."

P2 data • Wet Age-related Macular Degeneration

A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Unknown status ➔ Completed

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

A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME） (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

New P2 trial • Diabetic Macular Edema • Macular Edema • Ophthalmology

Intravitreal High-dose Efdamrofusp Alfa (IBI302) in Patients with Neovascular Age-related Macular Degeneration: A Randomized, Double-masked, Active-controlled, Phase 2 Study (ARVO 2025) - "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 • P2 data • Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects with NAMD (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

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

A Study of IBI302 in Patients With nAMD (clinicaltrials.gov) - P2 | N=231 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

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

Intravitreal High-Dose Efdamrofusp Alfa (IBI302) in Patients With nAMD: A Phase 2 Study (AAO 2024) - "The incidence of adverse events was similar among groups. Conclusion IBI302 demonstrated comparable efficacy and safety with extended dosing intervals in nAMD patients."

Clinical • P2 data • Ophthalmology • Wet Age-related Macular Degeneration

Efficacy and safety of efdamrofusp alfa versus aflibercept in participants with neovascular age-related macular degeneration: a randomized, double-masked, active-controlled, non-inferiority, phase 2 trial. (PubMed, Ophthalmol Retina) - "Efdamrofusp alfa demonstrated noninferiority to aflibercept in BCVA improvement, accompanied by a similar safety profile."

Head-to-Head • Journal • P2 data • Age-related Macular Degeneration • Immunology • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study of Longer Interval of IVT IBI302 in Subjects With nAMD (clinicaltrials.gov) - P2 | N=132 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Feb 2024 ➔ May 2024

Trial completion • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Innovent Announces Primary Endpoint Met in the Second Phase 2 Clinical Trial of IBI302 (anti-VEGF/complement) in Treating Neovascular Age-related Macular Degeneration (nAMD) (PRNewswire) - P2 | N=132 | NCT05403749 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that the primary endpoint has been met in the second Phase 2 clinical study of efdamrofusp alfa high-dose...in Chinese subjects with neovascular age-related macular degeneration....This was a randomized, double-masked, active-controlled Phase 2 clinical study (NCT05403749), evaluating the longer interval of intravitreal injection of high-dose IBI302 in subjects with nAMD. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group....The results showed that the primary endpoint was successfully met: at week 40, the IBI302 6.4 mg and 8.0 mg groups showed non-inferior BCVA gains to the Aflibercept 2.0 mg group....Detailed study data will be further analyzed and published in the near future."

P2 data • Wet Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

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

A Study of Longer Interval of IVT IBI302 in Subjects With nAMD (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Active, not recruiting

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

Innovent Presents Clinical Data of Two Ophthalmic Bispecific Antibodies IBI302 (anti-VEGF/complement) and IBI324 (anti-VEGF-A/Ang-2) at American Academy of Ophthalmology (AAO) Annual Meeting 2023 (PRNewswire) - P2 | N=231 | NCT04820452 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...presents latest data of two ophthalmic bispecific antibodies at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting....A total of 231 subjects with nAMD were randomized....The mean change from baseline in BCVA at week 36 was +10.6 letters in the IBI302 2 mg group, +11.4 letters in the IBI302 4 mg group, and +12.0 letters in the aflibercept 2 mg group....Preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence: The incidence of macular atrophy (MA) on spectral-domain optical coherence tomography (SD-OCT) and fibrosis on color fundus photography (CFP) at week 52 was 5.2% and 16.9% in the IBI302 2 mg group, 5.2% and 11.7% in the IBI302 4 mg group, and 9.1% and 14.3% in the aflibercept 2 mg group."

P2 data • Age-related Macular Degeneration

A Phase 2 Study of Anti-VEGF/Anti-Complement Bispecific Fc-Fusion Protein IBI302 for nAMD (AAO 2023) - "The incidence of adverse events was similar among treatment groups. Conclusion IBI302 was noninferior to 2-mg aflibercept in terms of BCVA improvement."

P2 data • Ophthalmology • Wet Age-related Macular Degeneration

Innovent Announces First Patient Dosed in the Phase 3 Clinical Study (STAR) of Efdamrofusp Alfa (IBI302), a First-in-class Ophthalmic Anti-VEGF and Anti-Complement Bispecific Fusion Protein for the Treatment of Neovascular Age-related Macular Degeneration (PRNewswire) - "Innovent Biologics...announces that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302), a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein. STAR is a randomized, double-masked, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of intravitreal 8 mg IBI302 in subjects with nAMD to support the potential new drug application for IBI302....A total of 600 subjects will be enrolled and randomized to 8mg IBI302 arm and 2mg aflibercept arm in a 1: 1 ratio..."

Trial status • Age-related Macular Degeneration

A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration