Diabetic eye disease: Developments that defined the first half of 2026

The first half of 2026 brought a steady drumbeat of regulatory and clinical news across the diabetic eye disease space, from a landmark autonomous AI screening clearance to phase 3 data challenging the decades-old standard of care for proliferative DR. Below is an overview of key developments from the first six months of 2026 in diabetic macular edema (DME) and diabetic retinopathy (DR).

FDA Approvals and Regulatory Milestones

FDA approves extended dosing intervals up to 20 weeks for EYLEA HD in wAMD and DME

In April, the FDA approved extended dosing intervals of up to every 20 weeks for aflibercept 8 mg (Eylea HD; Regeneron Pharmaceuticals) in both wet age-related macular degeneration (wAMD) and DME, building on the drug's existing label. The extension gives retina specialists additional flexibility to reduce treatment burden for patients who respond well to the higher-dose formulation.

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FDA approves ranibizumab-hkdz as first interchangeable biosimilar ranibizumab available in both vials and prefilled syringes

In June, the FDA approved ranibizumab-hkdz (Ranluspec; Lupin Limited), an interchangeable biosimilar referencing ranibizumab (Lucentis; Genentech), for wet AMD, DME, diabetic retinopathy, retinal vein occlusion, and myopic choroidal neovascularization. The approval covers both vial and prefilled syringe presentations, expanding the biosimilar options available to retina specialists across the full spectrum of diabetic eye disease indications.

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Late-Stage Clinical Trial Data

CONDOR clinical trial: Brolucizumab superior to panretinal photocoagulation for proliferative diabetic retinopathy

Published online in April in JAMA Ophthalmology, the phase 3 CONDOR trial (NCT04278417) found that brolucizumab (Beovu; Novartis) was both noninferior and superior to panretinal photocoagulation (PRP) for change in best-corrected visual acuity (BCVA) at week 54 in patients with proliferative diabetic retinopathy (PDR).

The 689-participant, 16-country trial randomized patients to brolucizumab 6 mg (3 loading doses every 6 weeks, then every 12 weeks) or PRP. The least-squares mean change in BCVA letter score was 0.2 for brolucizumab versus −4.2 for PRP, a difference of 4.4 letters (95% CI, 2.4-6.4; P < .001). More brolucizumab-treated patients had no PDR at week 54 (63.6% versus 22.4%; P < .001), and fewer experienced ocular adverse events (34.3% versus 49.1%). Intraocular inflammation, including retinal vasculitis, occurred in 5.2% of brolucizumab patients versus 0.6% of PRP patients.

First author Sebastian Wolf, MD, PhD, of the University of Bern, and colleagues concluded that brolucizumab may offer a viable alternative to PRP by reversing disease progression while preserving functional vision, though the inflammation signal warrants continued monitoring.

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Oculis completes final patient visit in OCS-01 phase 3 trial in DME

In April, Oculis announced completion of the final patient visit in its phase 3 trial evaluating OCS-01, a topical eye drop formulation, for DME. The company said it expects topline results in June 2026, a milestone that positions OCS-01 as a potential noninvasive alternative to intravitreal injection for DME management if the data read out positively.

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Pipeline and Early-Phase Developments

OLN324 shows comparable vision gains, potential durability advantage vs faricimab in phase 1b wAMD, DME study

Ollin Biosciences first reported topline positive results from its head-to-head phase 1b JADE study comparing OLN324, a VEGF/Ang2 bispecific antibody, with faricimab (Vabysmo; Genentech) at the beginning of the year. A fuller data readout in April showed that in the more than 160-patient study enrolling both DME and wAMD patients, OLN324 demonstrated numerically greater visual acuity gains and evidence of sustained retinal drying with fewer retreatments during a treatment-free follow-up period, compared with faricimab. Arshad M. Khanani, MD, MA, FASRS, a JADE study investigator, highlighted the speed and extent of retinal drying observed with OLN324 as notable versus the current highest bar for comparison in the class.

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Retina World Congress 2026: EYP-1901 phase 2 updates for wet AMD and DME

At Retina World Congress 2026 (May 14-17, Fort Lauderdale, Florida), Ashkan Abbey, MD, of Texas Retina Associates, presented an update on EYP-1901, a bioerodible tyrosine kinase inhibitor insert, in the phase 2 VERONA trial for DME. Previously treated DME patients randomized to EYP-1901 plus aflibercept met the primary end point of extended time to first supplemental injection; approximately 73% of the EYP-1901 group were supplemental-injection-free at trial end, compared with 50% in the aflibercept-alone group. Across roughly 190 patients who have received EYP-1901, Abbey reported no drug-related ocular or systemic serious adverse events and no cases of anterior chamber migration or occlusive vasculitis.

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The first half of 2026 underscored two parallel tracks in diabetic eye disease: incremental but meaningful gains in anti-VEGF durability and access (extended dosing, biosimilars, alternative delivery), alongside a maturing pipeline of non-VEGF mechanisms, from Wnt agonism to sustained-release TKIs, aiming to address patients who plateau on current therapy. The CONDOR data, in particular, may prompt reconsideration of PRP's role as the default for PDR.