Faricimab

The US FDA approved an extended dosing interval for Eylea HD (aflibercept), allowing Regeneron Pharmaceuticals to label the 8 mg intravitreal injection for dosing intervals of up to five months in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The company said this makes Eylea HD the first injectable anti-VEGF agent with a labelled interval of up to 20 weeks for both conditions, representing a label update to a product originally cleared by the US FDA in August 2023. The April 2026 approval specifically extends the maximum dosing interval beyond the 8-16 week range established at the time of the original approval. Under the updated label, patients with wAMD or DME who have completed one year of treatment may be eligible for the extended schedule. The formulation is a higher-concentration version of the established aflibercept molecule, delivered as an intravitreal injection, and developed in the US by Regeneron under its longstanding ophthalmic collaboration with Bayer, which retains commercialization rights outside the United States. The regulatory decision drew on 96-week data from two randomized, double-masked, non-inferiority pivotal trials: PULSAR, which enrolled patients with wAMD, and PHOTON, which enrolled patients with DME. Both studies compared aflibercept 8 mg against the established 2 mg dose of the same molecule. Published 48-week readouts, available via AllSci and PubMed, showed that visual acuity outcomes with the 8 mg formulation were non-inferior to those with the 2 mg reference dose at that timepoint. The company said the majority of patients in both trials maintained their visual and anatomic improvements when transitioned to extended dosing intervals over the full 96-week period, though the approval announcement did not disclose full 96-week efficacy tables or detailed safety breakdowns.. The approval lands in a retinal treatment field where the frequency of intravitreal injection has been a persistent clinical and practical concern. Anti-VEGF therapy transformed the management of wAMD and DME from the mid-2000s onward, converting conditions that frequently caused severe vision loss into ones where stabilization and, in many cases, functional improvement are achievable. Yet the injection burden associated with monthly or bimonthly dosing has long been identified as a factor in suboptimal real-world adherence, with patients and clinicians alike seeking regimens that reduce clinic visits without sacrificing disease control. Eylea HD joins a field that has already been moving toward extended durability as a central differentiating axis. Genentech’s faricimab (Vabysmo), approved in January 2022 for both wAMD and DME, introduced a bispecific mechanism targeting both VEGF-A and Angiopoietin-2, and carried labelling permitting up to 16-week dosing intervals from the outset of maintenance therapy. Genentech’s ranibizumab port delivery system, Susvimo, received US FDA approval for DME in February 2025, offering a surgically implanted refillable device that delivers continuous anti-VEGF exposure and requires refilling approximately every six months. The Eylea HD label update, at up to 20 weeks for eligible patients, extends the injectable interval further than any previously approved intravitreal anti-VEGF injection, as noted in the company’s announcement. The competitive context also includes an expanding biosimilar landscape for the original 2 mg aflibercept formulation, with Sandoz’s aflibercept-abzv (Enzeevu) receiving US FDA approval as an interchangeable biosimilar in August 2024. That dynamic adds complexity to Regeneron’s positioning of the higher-dose product, as cost-driven substitution of the reference 2 mg product becomes more feasible in parallel with the clinical case for the 8 mg formulation’s durability profile. Aflibercept itself is a fusion protein constructed from domains of VEGF receptor 1 and VEGF receptor 2 linked to an IgG1 Fc region, acting as a decoy receptor that sequesters VEGF-A, VEGF-B, and placental growth factor. Regeneron invented the molecule internally using its VelociSuite platform and has retained exclusive US commercialisation rights for the ophthalmic formulation throughout the product’s development history. The broader aflibercept franchise, including the original Eylea 2 mg product approved in 2011, has been one of Regeneron’s principal revenue sources for over a decade. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

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 Ollin and Innovent Biologics advancing OLN324 into global Phase 3 studies in DME and wAMD in 2026 SAN FRANCISCO and SUZHOU, China, March 30, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, today announced that the company's partner Ollin reported final, 20-week study completion data from its randomized, head-to-head Phase 1b JADE clinical study comparing OLN324(Innovent R&D code IBI324) , 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 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) with OLN324. 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 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 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 Dr. 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 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 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 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 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 MD Anderson Cancer Center. 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 , or follow Innovent on Facebook and LinkedIn. Disclaimer: Innovent does not recommend any off-label usage. Vabysmo® is a registered trademark of Genentech, Inc.; Eylea® and Eylea HD® are registered trademarks of Regeneron Pharmaceuticals, Inc. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics 21% more press release views with Request a Demo