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

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 demonstrate OLN324 achieves faster, greater, and more durable reductions in wAMD pigment epithelial detachment (PED) thickness versus faricimab

Ollin and Innovent Biologics advancing OLN324 into global Phase 3 studies in DME and wAMD in 2026

AUSTIN, Texas--(BUSINESS WIRE)--Ollin Biosciences, Inc. (Ollin), a clinical-stage biotech advancing best-in-disease therapies for vision-threatening diseases, today announced final 20-week study completion data from its randomized, head-to-head Phase 1b JADE clinical study comparing OLN324, a higher-potency, smaller-format, higher-molar dose VEGF/Ang2 bispecific antibody, to faricimab (Vabysmo®), in patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD). Final results released today include favorable durability data for OLN324 compared to faricimab and new anatomic data showing faster, greater, and more durable control of wAMD pigment epithelial detachments (PEDs).

Topline data from the Week 12 primary endpoint readout, previously announced in January 2026 and presented at the Angiogenesis, Exudation, and Degeneration symposium in February 2026, demonstrated OLN324, compared to faricimab, delivered superior anatomic outcomes in DME, including faster and greater retinal drying and more patients achieving absence of DME; equivalent retinal drying compared to faricimab in wAMD; rapid and sustained gains in vision in both DME and wAMD that were numerically better than faricimab; and had a favorable safety profile with no cases of intraocular inflammation.

Final 20-Week Study Completion Data Highlights

In 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 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.

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 best-corrected visual activity (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 Jason Ehrlich, M.D., Ph.D., Co-founder and Chief Executive Officer of Ollin Biosciences. “We look forward to advancing OLN324 into global Phase 3 studies in both DME and wAMD later this year. Subject to regulatory communications, we expect the Phase 3 studies to recruit patients from North America, South America, Europe and Japan, and we are actively planning, in partnership with Innovent Biologics, to include China and South Korea.”

“We are pleased to see that the latest 20-week data for OLN324 (IBI324) further highlight its differentiated profile and clinical potential,” said Lei Qian, M.D., Ph.D., Chief R&D Officer of General Biomedicine at Innovent Biologics. “We look forward to continuing our close collaboration with Ollin and, following discussions with regulatory authorities, to accelerate the global Phase 3 clinical development of this best-in-disease therapy for retinal diseases.”

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 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 David Eichenbaum, M.D., FASRS, Director of Research, Retina Vitreous Associates of Florida. “These data suggest that OLN324’s more potent Ang2 inhibition and smaller molecular format may translate into breaking through the efficacy ceiling experienced with current treatments and offering a clinically-relevant benefit in PED improvement – the most difficult to treat component of wAMD.”

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 the United States. All patients initially received three monthly doses of either OLN324 2 mg, OLN324 4 mg, or faricimab 6 mg. Patients were evaluated at Weeks 1, 4, 8, 12, 16, and 20 and could be retreated at Weeks 12 or 16 based on protocol-specified retreatment criteria that were the same for all groups. The primary objective was to assess safety and tolerability (through Week 12 and Week 20). Prespecified exploratory efficacy objectives included the evaluation of OLN324 vs. faricimab on visual acuity and various retinal anatomic parameters.

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 Innovent Biologics (HKEX: 01801; Innovent R&D code: IBI324).

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 Biosciences^TM 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.

Vabysmo® is a registered trademark of Genentech, Inc.; Eylea® and Eylea HD® are registered trademarks of Regeneron Pharmaceuticals, Inc.