IBI-324 / Innovent Biologics, Ollin Biosciences - LARVOL DELTA

Ollin Biosciences Announces Presentations and Symposium at EURETINA 2026 (Businesswire) - "Ollin Biosciences...announced an upcoming presentation of results from its previously completed head-to-head JADE proof-of-concept clinical trial evaluating OLN324 versus faricimab (Vabysmo) in patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (wAMD) at the 26th European Society of Retina Specialists (EURETINA) Annual Congress, taking place in Vienna, Austria, from October 1-4, 2026....In addition, Ollin announced a symposium on the promise of next-generation VEGF/Ang2 dual inhibition, featuring leading international ophthalmology faculty."

P1 data • Diabetic Macular Edema • Wet Age-related Macular Degeneration

GOBI: Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-03) (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Ollin Biosciences, Inc.

New P3 trial • Diabetic Macular Edema • Ophthalmology

ATACAMA: Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-02) (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Ollin Biosciences, Inc.

New P3 trial • Diabetic Macular Edema • Ophthalmology

SAHARA: Phase 3 Study of Intravitreal OLN324 in Adults With Neovascular (Wet) Age-related Macular Degeneration (nAMD) (OLN324-CP-05) (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Ollin Biosciences, Inc.

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

MOJAVE: Phase 3 Study of Intravitreal OLN324 in Adults With Neovascular (Wet) Age-related Macular Degeneration (nAMD) (OLN324-CP-04) (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Ollin Biosciences, Inc.

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

A VEGF/Ang-2 inhibitor demonstrated faster drying compared with faricimab in patients with diabetic macular edema, according to a study presented at Clinical Trials at the Summit. (Healios Press Release) - "Chang said OLN324 was well tolerated in patients with DME through week 20, and there were no cases of intraocular inflammation in either group that received OLN324...The OLN324 groups had a greater and faster change in central subfield thickness compared with faricimab...Additionally, 93% of patients who received OLN324 did not need re-treatment and maintained anatomic improvement through week 20...Patients in the OLN324 groups experienced visual acuity improvements, according to Chang. At week 12, the 2 mg group had a mean change in best corrected visual acuity of 8.4 letters and the 4 mg group had a mean change of 7.7 letters compared with 6.9 letters in the faricimab group, according to the study."

P1 data • Diabetic Macular Edema

ASRS 2026: JADE trial shows OLN324 achieves faster retinal drying and durable response over faricimab in DME (Ophthalmology Times) - "The JADE DME cohort enrolled 83 treated patients across three arms from 30 US sites. Anatomic differentiation emerged as early as week 1, with least squares mean central subfield thickness reductions of 76.3 µm and 79.0 µm for OLN324 2 mg and 4 mg, respectively, compared with 44.8 µm for faricimab. At week 12, absence of DME was achieved in 84.6% and 88.5% of patients in the OLN324 2 mg and 4 mg arms, respectively, vs 57.1% in the faricimab arm (nominal P = .003). No cases of intraocular inflammation occurred in either OLN324 dose group, and no treatment-related serious adverse events were observed in any arm."

P1 data • Diabetic Macular Edema

Ollin Biosciences Announces Upcoming Presentations of OLN324 Data in Diabetic Macular Edema and Wet Age-Related Macular Degeneration at the American Society of Retina Specialists (ASRS) 44th Annual Scientific Meeting (Businesswire) - "Ollin Biosciences...announced upcoming oral presentations featuring results from its randomized, head-to-head Phase 1b JADE clinical trial evaluating OLN324 versus faricimab (Vabysmo) in patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (wAMD)....OLN324 is a higher-potency, smaller-format, higher-molar dose VEGF/Ang2 bispecific antibody entering Phase 3 clinical development for DME and wAMD in the second half of 2026."

New P3 trial • P1 data • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Ollin Biosciences Announces Oversubscribed $330 Million Series B Financing to Advance Global Phase 3 Development of OLN324 in DME and Wet AMD; Studies Commencing in Second Half of 2026 (Businesswire) - "Proceeds from the Series B financing will support the global Phase 3 development of OLN324, a next-generation VEGF/Ang2 bispecific antibody, in diabetic macular edema (DME) and wet (neovascular) age-related macular degeneration (wAMD)...Ollin has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and has received scientific advice from the European Medicines Agency (EMA) on the Phase 3 program, and plans to initiate global Phase 3 trials of OLN324 in DME and wAMD in the second half of 2026."

European regulatory • FDA event • Financing • New P3 trial • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Ollin Biosciences Announces Upcoming Presentations of 20-week Data from Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration at Clinical Trials at the Summit 2026 (Businesswire) - "OLN324 is a higher-potency, smaller-format, higher-molar dose VEGF/Ang2 bispecific antibody expected to enter Phase 3 clinical development for DME and wAMD in the second half of 2026. In the Phase 1b JADE study, OLN324 demonstrated meaningfully faster and greater anatomic outcomes in both DME and wAMD versus faricimab as well as numerically greater vision gains."

New P3 trial • P1 data • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Ollin Biosciences Announces Final Data From Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo) in Wet Age-Related Macular Degeneration and Diabetic Macular Edema (Yahoo Finance) - "New anatomic data demonstrate OLN324 achieves faster, greater, and more durable reductions in wAMD pigment epithelial detachment (PED) thickness versus faricimab...At the final study visit of Week 20, 12 weeks after the last mandatory dose, DME patients treated with OLN324 continued to demonstrate greater retinal drying compared to those treated with faricimab, measured as mean change in central subfield thickness on optical coherence tomography (OCT), along with sustained vision gains that were numerically greater for OLN324 4 mg...'We look forward to advancing OLN324 into global Phase 3 studies in both DME and wAMD later this year.'....Full details of the final JADE study data are expected to be presented at upcoming medical and scientific conferences."

New P3 trial • P1 data • Diabetic Macular Edema • Wet Age-related Macular Degeneration

JADE: A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324 (clinicaltrials.gov) - P1 | N=164 | Completed | Sponsor: Ollin Biosciences, Inc.

New P1 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration (GlobeNewswire) - "OLN324 demonstrated both faster and greater retinal drying versus faricimab in patients with DME, with OLN324 4mg treated patients experiencing mean improvements in retinal drying that were ~75% greater than faricimab at Week 1 (-79 µm vs. -45 µm mean change in central subfield thickness or CST, respectively), and ~50% greater at Week 12 (-180 µm vs. -121 µm), measured using optical coherence tomography (OCT)....Ollin plans to discuss the JADE study and additional pipeline and corporate progress during its upcoming presentation at the 44th Annual J.P. Morgan Healthcare Conference, on Tuesday, January 13, 2026. Full results of the study will be presented for the first time at the upcoming Angiogenesis, Exudation, and Degeneration 2026 symposium on February 7, 2026."

P1 data • Pipeline update • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Ollin plans to initiate global Phase 3 trials of OLN324 in DME and wAMD in 2026 (Businesswire)

New P3 trial • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Phase 1 dose-escalation study of IBI324, a VEGF-A/Ang-2 bispecific antibody, for the treatment of diabetic macular oedema. (PubMed, BMJ Open Ophthalmol) - P1 | "IBI324 was well tolerated with evidence of functional and anatomical improvement in patients with DME."

Journal • P1 data • Cataract • Conjunctivitis • Diabetic Macular Edema • Macular Edema • Ocular Infections • Ocular Inflammation • Ophthalmology

Innovent's Partner Ollin Announces Clinical Updates on IBI324 (OLN324, VEGF/ANG-2) (PRNewswire-Asia) - "Ollin has completed enrollment of over 150 patients with wAMD or DME in the JADE study, a randomized, U.S.-based, Phase 1b proof-of-concept clinical trial designed to evaluate OLN324 versus faricimab for potential areas of anatomic and durability differentiation. Topline results from the study are expected in the first quarter of 2026."

Enrollment closed • P1 data • Diabetic Macular Edema • Wet Age-related Macular Degeneration

IBI324/OLN324: A clinical-stage, small-format, higher-potency, high molar dose bispecific VEGF/Ang-2 inhibitor (ARVO 2025) - "OLN324 (IBI324) is a novel, small-format (~41 kDa) bispecific antibody targeting VEGF and Ang-2 with substantially higher potency and molar dose than faricimab, features giving it the potential for better clinical efficacy and durability. 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 • Ocular Inflammation • Ophthalmology • Wet Age-related Macular Degeneration

A Phase 1 Study of Anti-VEGF/Anti-Angiopoietin 2 Bispecific Antibody IBI324 for DME (AAO 2023) - "Furthermore, improvements in anatomical parameters were also observed after IBI324 treatment. Conclusion IBI324 was well tolerated and safe, with a preliminary visual and anatomical efficacy signal."

P1 data • Diabetic Macular Edema • Ophthalmology

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) - P1 | N=24 | NCT05489718 | 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....This is a Phase 1 clinical study evaluating the safety, tolerability, and efficacy of IBI324 in the treatment of DME....In terms of safety, 4 mg/eye was the maximum tolerated dose in the study. No ocular serious adverse events (SAE), intraocular inflammation, or dose-limiting toxicities (DLTs) occurred during the study. In the SAD phase, BCVA and CST improved from baseline to Day 42 post-dose in every IBI324 dose group. In the MAD phase, BCVA improved from baseline by 6.7±5.4 letters and 7.7±4.7 letters in the IBI324 2 mg and 4 mg groups, respectively, by 4 weeks after the third dose (Day 84)."

P1 data • Diabetic Macular Edema

A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Jun 2023

Trial completion • Trial completion date • Diabetic Macular Edema • Ophthalmology

A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P1 trial • Diabetic Macular Edema • Ophthalmology