Innovent's Partner Ollin Biosciences Announces Final Data from Randomized Head-to-Head Study of IBI324 Compared to Faricimab (Vabysmo) in Wet Age-Related Macular Degeneration and Diabetic Macular Edema
- OLN324 demonstrated meaningfully faster and greater improvements in anatomic outcomes in DME and numerically greater vision gains sustained through 20 weeks with fewer retreatments as compared to faricimab
- New anatomic data demonstrates OLN324 achieves faster, greater, and more durable reductions in wAMD pigment epithelial detachment (PED) thickness versus faricimab
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Ollin and
Innovent Biologics
Topline data from the Week 12 primary endpoint readout, previously announced in
Final 20-Week Study Completion Data Highlights
The JADE trial, which enrolled 164 U.S. patients with either DME or wAMD, all patients initially received three monthly doses of OLN324 or faricimab. Thereafter, they were followed for an additional 12 weeks off treatment, during which they could be retreated based on protocol-specified criteria for disease recurrence that were the same for all groups.
At the final study visit at 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, along with sustained vision gains that were numerically greater for OLN324 4 mg.
These improved efficacy outcomes were achieved with fewer retreatments compared to faricimab. 93% of DME patients randomized to OLN324 4 mg completed 12 weeks of follow-up without retreatment, versus 89% of patients randomized to faricimab.
In wAMD, the rapid and comparable improvements in retinal drying (mean change in OCT CST) observed from Day 1 to Week 12 with OLN324 and faricimab were sustained through Week 20. Patients treated with OLN324 experienced numerically greater vision gains than patients treated with faricimab; the BCVA improvements continued to separate between groups from Weeks 12 to 20, with a mean +2.2 letter advantage observed over faricimab for OLN324 4 mg at Week 20.
82% of OLN324 4 mg patients completed 12 weeks of follow-up without retreatment, compared with 81% of faricimab patients.
OLN324 continued to demonstrate a favorable safety profile, with zero cases of intraocular inflammation observed through the entirety of the study, compared with one case in a faricimab-treated patient. There were no cases of retinal vasculitis or occlusive retinal vasculitis with OLN324.
"These new JADE study data further strengthen the differentiated profile of OLN324, highlighting its robust anatomic efficacy and durability across both DME and wAMD. Combined with a favorable safety profile, these results underscore OLN324's potential to become a first-line treatment option for these vision-threatening diseases," said
"We are pleased to see that the latest 20-week data for OLN324 (IBI324) further highlight its differentiated profile and clinical potential," said Dr.
New Anatomic Results on Pigment Epithelial Detachment (PED) Flattening Highlight Potential for Smaller-Format, Higher-Potency OLN324 to Improve Treatment of wAMD
In newly-available, pre-specified data, wAMD patients in the JADE trial randomized to OLN324 4 mg experienced faster and approximately 50% greater reductions in PED thickness at Week 12 compared to patients randomized to faricimab, measured as mean change in neovascular lesion complex thickness on optical coherence tomography (OCT). Through Week 20, in the off-treatment follow-up period, these improvements were more durable for patients randomized to OLN324 4 mg than faricimab.
"As a field, we've been looking for meaningful advancements that further improve anatomic outcomes in wAMD," said
Retinal fluid (intraretinal and subretinal) and PEDs are two hallmark anatomic features of wAMD. PEDs are present in approximately 80% of wAMD patients. Persistent PEDs following anti-VEGF treatment are associated with development of subretinal fibrosis, an important cause of late vision loss in wAMD.
Full details of the final JADE study data are expected to be presented at upcoming medical and scientific conferences.
About the OLN324 JADE Study
JADE is a randomized, head-to-head Phase 1b clinical study comparing OLN324, a next-generation VEGF/Ang2 bispecific antibody, to faricimab (Vabysmo®), in patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD). More than 160 patients with wAMD or DME were enrolled at sites in
About OLN324
Building on the clinical success of intravitreal VEGF/Ang2 inhibition, OLN324 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 diabetic macular edema (DME) and wet (neovascular) age-related macular degeneration (wAMD), with Ang2 playing a key role in vascular instability, leakage, inflammation, and fibrosis. OLN324 was discovered by and is being developed in collaboration with
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 result in vascular leakage and retinal swelling that compromise vision.
About Wet Age-Related Macular Degeneration (wAMD)
Age-Related Macular Degeneration, 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 BiosciencesTM 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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