KEY TAKEAWAYS
- SOL-1 phase 3 data showed a single injection of OTX-TKI (Axpaxli; Ocular Therapeutix) outperformed aflibercept 2 mg on vision maintenance through 52 weeks in treatment-naive wet AMD, with a favorable safety profile aside from hydrogel-related floaters.
- The FDA approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as the first interchangeable ranibizumab biosimilar available in both vial and prefilled syringe formats, spanning wet AMD, DME, DR, RVO, and mCNV indications.
- Two geographic atrophy features, a retrospective imaging study and a clinician roundtable, offered practical guidance on lesion monitoring and treatment sequencing as complement inhibitors approach their third year on the market.
June leaned heavily on geographic atrophy (GA) and anti-VEGF durability, alongside a marquee phase 3 readout and a new biosimilar approval. Below is an overview of 6 key items from June 2026.
Optimizing anti-VEGF in AMD, DME, and RVO: Strategies for durable disease control
Michael Ammar, MD, vitreoretinal surgeon and codirector of clinical research at Retina Consultants San Diego, moderated a Case Based Roundtable examining how second-generation anti-VEGF agents are extending treatment intervals across age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
In the AMD case, a treatment-naive patient with newly diagnosed neovascular AMD was started on bevacizumab (Avastin; Genentech) every 4 weeks but developed worsening macular edema and choroidal neovascularization (CNV) growth on attempted extension to 6 weeks. After switching to faricimab (Vabysmo; Genentech), the fluid resolved, the CNV flattened, and the patient extended to 13 weeks between injections. Ammar called the contrast a clear illustration of how second-generation agents outperform older anti-VEGF therapy on durability.
A related RVO case showed a similar pattern: an aflibercept 2 mg (Eylea; Regeneron) nonresponder who could not extend past 6 weeks achieved at least 8-week intervals after switching to aflibercept 8 mg (Eylea HD; Regeneron). Across the roundtable, participants also reported using fewer adjunctive intraocular steroids in DME given the durability of newer anti-VEGF monotherapy.
Click here to read the full coverage on Modern Retina.
The Wills Retina Report: Regillo and Garg on managing geographic atrophy—who, when, and how
This debut podcast episode features Carl D. Regillo, MD, FACS, FASRS, and Sunir J. Garg, MD, FACS, FASRS, both of Wills Eye Hospital and Mid-Atlantic Retina, discussing how geographic atrophy (GA) management has evolved since pegcetacoplan (Syfovre; Apellis Pharmaceuticals) and avacincaptad pegol (Izervay; Astellas Pharma) reached the market in 2023.
The pair discussed patient selection, noting that reticular pseudodrusen on near-infrared imaging signals both faster GA progression and elevated CNV risk. On dosing, both favor 8-week intervals over 4-week intervals, citing a lower rate of secondary CNV and endophthalmitis at the longer interval, both attributed to the polyethylene glycol component shared by the 2 drugs. Regillo noted that intraocular inflammation rates run modestly higher with pegcetacoplan than with avacincaptad pegol, and that the vasculitis-pattern inflammation with retinal occlusion reported with pegcetacoplan has not been observed with avacincaptad pegol to date.
Click here for the full coverage on Modern Retina.
Geographic atrophy: When lesion borders cannot be graded
This retrospective, cross-sectional study out of the Doheny Eye Institute and UCLA examined how often geographic atrophy (GA) lesion borders cannot be reliably measured on ultrawidefield green-light fundus autofluorescence (UWF GAF), an increasingly common imaging modality in retina practice.
Among 88 patients (138 eyes) with GA secondary to nonexudative AMD, UWF GAF images were ungradable in 7 of 138 eyes (5.1%; 95% CI, 2.5%-10.1%). Ungradable eyes had markedly thinner choroids than gradable eyes at the subfoveal point (74.71 ± 37.04 μm vs 177.41 ± 91.16 μm; P = .0002), with similar differences at the nasal (P = .0013) and temporal (P = .018) points. The authors attributed the finding to increased scleral autofluorescence as choroidal tissue thins, and noted that companion ultrawidefield pseudocolor imaging salvaged gradability in 6 of the 7 ungradable eyes, reducing the true ungradability rate to about 1%.
Click here to read the full coverage on Modern Retina.
Clinical Trials at the Summit 2026: First-time data, AI, and the next generation of retinal treatments
Published ahead of the June 12-13 meeting in Las Vegas, Nevada, this preview features Arshad M. Khanani, MD, MA, FASRS, founder and co-chair of Clinical Trials at the Summit, outlining the program's focus areas for its sixth year.
The scientific program, scheduled to include roughly 90 rapid-fire talks, will cover new data on approved neovascular AMD treatments alongside emerging tyrosine kinase inhibitors and gene therapy candidates aimed at reducing treatment burden. Dry AMD sessions will address biomarkers, imaging, and functional end points, and a dedicated track will examine the role of artificial intelligence in trial pre-screening and design. Khanani noted that several early- and mid-stage gene therapy data sets will be presented publicly for the first time.
Click here to read the full coverage on Modern Retina.
FDA approves ranibizumab-hkdz as first interchangeable biosimilar ranibizumab available in both vials and prefilled syringes
In early June, the US Food and Drug Administration (FDA) approved ranibizumab-hkdz (Ranluspec; Lupin Limited), a biosimilar referencing ranibizumab (Lucentis; Genentech), as an interchangeable biosimilar across wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), retinal vein occlusion (RVO)-associated macular edema, and myopic choroidal neovascularization (mCNV).
Ranibizumab-hkdz is approved in both .3 mg and .5 mg strengths, available in vial and prefilled syringe presentations at both doses, making it the only ranibizumab biosimilar with interchangeable status across both formats. The interchangeable designation permits pharmacist-level substitution without physician intervention, subject to state law.
Cyrus Karkaria, PhD, president of Biotechnology at Lupin, told Modern Retina that the prefilled syringe format reduces preparation steps in high-volume intravitreal injection programs, potentially improving procedural efficiency and reducing handling variability. Wet AMD affects an estimated 1.7 million Americans, and cost has been cited as a barrier to consistent anti-VEGF adherence; commercial availability and pricing for ranibizumab-hkdz have not yet been announced.
Click here to read the full coverage on Modern Retina.
Phase 3 data support OTX-TKI's durability in wet AMD: 1 injection, 1 year
Arshad M. Khanani, MD, MA, FASRS, an investigator on the trial, presented SOL-1 (NCT06223958), a phase 3 pivotal trial of OTX-TKI (Axpaxli; Ocular Therapeutix) in treatment-naive neovascular AMD.
Patients received a single injection of OTX-TKI or aflibercept 2 mg following 2 aflibercept loading doses. The primary end point, the proportion maintaining vision (loss of fewer than 15 ETDRS letters) at week 36, was met: 74.1% of OTX-TKI patients maintained vision versus 55.8% with aflibercept (P = .0006). At week 52, those figures were 65.9% and 44.2%, respectively. OTX-TKI also showed superior anatomic control, with 68.8% versus 52.9% of patients achieving central subfield thickness of 350 μm or less at week 36, and higher rescue-free rates at both week 36 (74.7% vs 56.4%) and week 52 (68.8% vs 47.7%). The main safety signal was vitreous floaters, reported in 12.4% of OTX-TKI patients versus 1.2% with aflibercept, corresponding to hydrogel dissolution; there were no cases of endophthalmitis or retinal vasculitis. Khanani described OTX-TKI as a first-in-class tyrosine kinase inhibitor with 9- to 12-month durability in wet AMD.
Click here to read the full coverage on Modern Retina.
