Innovent's Partner Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of IBI324 Compared to Faricimab (Vabysmo®) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration
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). Additionally, nearly 90% of OLN324 4mg treated patients achieved absence of DME at Week 12, defined as CST < 325 µm, as compared to 57% of faricimab patients.
All treatment groups yielded equivalent anatomic outcomes in patients with wAMD, with rapid improvements in OCT mean CST as early as Week 1 that were sustained through Week 12. Patients across all treatment groups experienced rapid and sustained mean gains in vision (best-corrected visual acuity, or BCVA) with numerically greater improvements at Week 12 with OLN324 than faricimab in both DME and wAMD.
"DME is among the most challenging retinal diseases to treat and has long served as a proving ground for therapies that ultimately become first-line standard of care in retinal diseases. The difference in speed and extent of retinal drying observed with OLN324 versus faricimab, the highest bar comparator in DME, is compelling and clinically significant. In real-world practice, this best-in-disease outcome could lead to broad utility for OLN324 across all the major retinal diseases," said
"OLN324 is the first and only therapy to demonstrate superior anatomic efficacy compared to the market leader, faricimab, in a head-to-head, randomized clinical trial," said
"We are excited about by the progress of OLN324 (IBI324), driven forward by our partner Ollin, especially the successful results of the JADE Phase 1b trial in head-to-head comparison with faricimab," stated Dr.
In a previously-completed Phase 1 single and multiple dose escalation study, IBI324 (OLN324) demonstrated promising vision and anatomic improvements in Chinese DME patients along with a favorable safety profile. IBI324 (OLN324) was discovered by Innovent and is being developed in collaboration with Ollin.
Ollin plans to discuss the JADE study and additional pipeline and corporate progress during its upcoming presentation at the 44th Annual
About JADE
More than 160 patients with wAMD or DME were enrolled at sites in
A favorable safety profile was observed with OLN324, with no cases of intraocular inflammation (IOI) observed at either dose level during the study. One case of IOI was observed in a patient treated with faricimab. There were no cases of retinal vasculitis or occlusive retinal vasculitis.
About OLN324 （ IBI324 ）
Building on the clinical success of intravitreal VEGF/Ang2 inhibition, IBI324 is a next-generation VEGF/Ang2 bispecific antibody engineered with substantially higher Ang2 potency relative to faricimab, increased molar dosing relative to both faricimab and aflibercept (including Eylea HD®), and a smaller protein format. VEGF and Ang2 are central drivers of retinal vascular diseases such as DME and wAMD, with Ang2 playing a key role in vascular instability, leakage, inflammation, and fibrosis. OLN324 was discovered by Innovent and is being developed in collaboration with Ollin Biosciences (Ollin R&D code: OLN324).
About Diabetic Macular Edema (DME)
Diabetic macular edema, a vision-threatening complication of diabetic eye disease, is a leading cause of vision loss among working-age adults in the developed world. In diabetic macular edema, progressive microvasculature damage, ischemia, and microvascular inflammation results in vascular leakage and retinal swelling that compromise vision.
About Wet Age-Related Macular Degeneration (wAMD)
AMD, a chronic and progressive retinal disease, is the leading cause of vision loss among older adults in the developed world. In wet (or neovascular) AMD, abnormal blood vessels growing beneath the retina leak and bleed, resulting in significant vision impairment.
About Ollin Biosciences
Established in 2023, Ollin Biosciences™ is a clinical-stage biopharmaceutical company dedicated to acquiring and developing best-in-disease therapies for vision-threatening diseases. With a differentiated pipeline, world-class team, and strong investor syndicate, Ollin is redefining what's possible in ophthalmology. For more information, please visit us at www.ollin.bio and follow us on LinkedIn and X.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and
Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Disclaimer: Innovent does not recommend any off-label usage.
Vabysmo® is a registered trademark of
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