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

OLN324, a next-generation VEGF/Ang2 bispecific antibody, demonstrated meaningfully faster and greater improvements in anatomic outcomes in DME and numerically greater vision gains versus faricimab

Nearly 90% of DME patients treated with OLN324 4mg achieved absence of disease at 12 weeks compared to 57% of patients treated with faricimab

By demonstrating faster and greater retinal drying with a clean safety profile, OLN324 has the potential to become the new standard of care in the ~$15 billion worldwide market for retinal therapeutics

Ollin plans to initiate global Phase 3 trials of OLN324 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 positive topline results from its randomized, head-to-head Phase 1b JADE clinical study comparing OLN324, a next-generation VEGF/Ang2 bispecific antibody, to faricimab (Vabysmo^®), in over 160 patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD). OLN324’s up to 60-fold higher anti-Ang2 potency, together with a smaller protein format and a higher molar dose, gives OLN324 a differentiated, first-line standard of care profile.

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 4 mg 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.

“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 Jason Ehrlich, M.D., Ph.D., Co-founder and Chief Executive Officer of Ollin Biosciences. “These data validate that a higher potency, higher molar dose, smaller format VEGF/Ang2 bispecific can more fully realize the therapeutic potential of dual VEGF and Ang2 inhibition. By achieving faster and greater retinal drying in DME, OLN324 has the potential to become the new standard of care in the ~$15 billion worldwide market for retinal therapeutics.”

“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 Arshad M. Khanani, M.D., M.A., FASRS, Managing Partner and Director of Clinical Research at Sierra Eye Associates, JADE study investigator and Ollin Scientific Advisory Board member.

“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. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent Biologics. “As a next-generation VEGF/Ang-2 bispecific antibody, OLN324 holds the potential to deliver differentiated clinical value for patients with retinal diseases. We look forward to continuing our close collaboration with Ollin to accelerate the global development of this best-in-disease drug.”

Dr. Ehrlich added, “We look forward to discussing these data with health authorities and moving OLN324 quickly into global Phase 3 studies in both DME and wet AMD.”

Ollin plans to discuss the JADE study and additional pipeline and corporate progress during its upcoming presentation at the 44^th 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.

About JADE

More than 160 patients with wAMD or DME were enrolled at sites in the United States in the JADE study. 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. Primary efficacy outcomes were evaluated at Week 12; results achieved at Week 12 with OLN324 2 mg were similar to 4 mg.

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

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 DME and 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 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^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.