August 2026 retina highlights: Catch up on trial, regulatory, and diagnostic updates

August 2026 was a pipeline-driven month for retina, with movement concentrated at the regulatory front and in late-phase trial operations. A priority review decision in an inherited retinal disease headlined the period, while 2 pivotal programs in diabetic macular edema (DME) and uveitic macular edema hit enrollment and cohort milestones that set up readouts through 2027. Alongside the pipeline news, clinicians got a pointed reminder that diagnostic precision still matters, particularly as invasive therapies reach the clinic. Catch up on any major news you may have missed below.

Regulatory and pipeline milestones

FDA grants priority review to tinlarebant for Stargardt disease type 1

In August 2026, the FDA accepted the new drug application for tinlarebant (LBS-008; Belite Bio) and granted it priority review for the treatment of Stargardt disease type 1 (STGD1), an inherited retinal degeneration with no approved treatment. An oral retinol-binding protein 4 antagonist designed to reduce the accumulation of toxic vitamin A byproducts in the retina, tinlarebant would be a first-in-disease option if approved.

The application is supported by the phase 3 DRAGON trial (NCT05244304), in which the primary end point was the growth rate of atrophic retinal lesions. Treatment was associated with a 35.7% reduction in lesion growth rate versus control. Byron Lam, MD, of Bascom Palmer Eye Institute, and Benjamin Bakall, MD, PhD, of the University of Arizona and Associated Retina Consultants, offered perspective on what a priority review means for a young patient population that has had only supportive care to date.

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KSI-101 completes first pivotal cohort in the phase 3 PEAK trial

Kodiak Sciences reported that its bispecific biologic tabirafusp alfa (KSI-101; Kodiak Sciences) completed enrollment of the first pivotal cohort, roughly 300 patients, in the phase 3 PEAK trial (NCT06990399). KSI-101 inhibits both interleukin-6 and VEGF, a dual mechanism aimed at macular edema secondary to non-infectious inflammation (MESI) in patients with uveitis.

PEAK is a randomized, double-masked, sham-controlled study evaluating two doses of KSI-101 against sham, with a primary end point of mean change in best-corrected visual acuity (BCVA) from day 1 to the average of weeks 20 and 24. Supporting phase 1b APEX data showed BCVA gains of 13.4 letters at the 5-mg dose and 15.4 letters at the 10-mg dose at week 20, with 90% or more of patients achieving absence of intraretinal or subretinal fluid. First pivotal 24-week data are expected in December 2026, with a second pivotal analysis of approximately 600 pooled patients anticipated in the second quarter of 2027. "If we see rapid and dramatic anatomical improvement, we will have a remarkable new, effective option for MESI," said David A. Eichenbaum, MD, FASRS.

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DURAVYU phase 3 DME trials COMO and CAPRI complete enrollment

EyePoint announced that its sustained-delivery insert vorolanib intravitreal insert (DURAVYU, EYP-1901; EyePoint) completed enrollment in the pivotal phase 3 COMO (NCT07449936) and CAPRI (NCT07449923) trials in diabetic macular edema (DME). More than 480 patients were randomized across the two studies, with enrollment finishing in approximately 5 months, ahead of the projected timeline.

EYP-1901 is an office-based intravitreal insert dosed twice yearly, and the trials compare it against aflibercept to test whether the durable insert can hold the visual and anatomic gains of a standard anti-VEGF agent while reducing treatment burden. Topline 56-week data are anticipated in the fourth quarter of 2027.

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MK-8748's dual mechanism draws interest in wet AMD

Margaret A. Chang, MD, MS, discussed the rationale behind MK-8748 (tiespectus; Merck & Co), a bispecific antibody that agonizes the Tie2 receptor to promote vascular stabilization while inhibiting VEGF. The candidate is in the pivotal phase 2b/3 MALBEC and TORRONTES trials in wet age-related macular degeneration (AMD), both comparing MK-8748 against aflibercept with a primary end point of BCVA change at year 1.

Chang pointed to early phase 1/2a RIOJA data, in which patients with branch retinal vein occlusion gained a mean of 16.7 letters with a 157.8-µm reduction in central subfield thickness at 12 weeks, as evidence that Tie2 activation may add value beyond anti-VEGF alone. "If there is a signal for improvement in visual outcome with a new therapy, patient management may significantly shift, even if retreatment frequency does not change," she said, noting that a meaningful subset of patients responds inadequately to VEGF suppression on its own.

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Clinical and diagnostic insights

Confirming a MacTel2 diagnosis before treatment: Noah Banoub on common mimics

With a surgically implanted therapy now approved for macular telangiectasia type 2 (MacTel2), diagnostic accuracy has become a treatment-selection issue, not just an academic one. Noah G. Banoub reviewed real-world data showing that 25.5% of patients labeled with MacTel2 did not meet strict diagnostic criteria; of 754 patients reviewed, only 562 (74.5%) truly had the condition.

Banoub framed MacTel2 as a primarily neurodegenerative disease driven by Müller cell dysfunction, with vascular changes secondary, and cautioned that features such as temporal telangiectatic vessels or isolated microaneurysms are not sufficient for a firm diagnosis. Common mimics include hypertensive retinopathy, retinal vein occlusion (RVO), DME, epiretinal membrane, and AMD. He advocated for multimodal imaging, including optical coherence tomography (OCT) signs such as loss of foveal contour, inner retinal cavitations with ILM draping, and ellipsoid zone disruption, supported by fluorescein angiography and fundus autofluorescence. The stakes rose with the approval of revakinagene taroretcel-lwey (Encelto), he noted, because MacTel2 "is now a diagnosis that can lead to an invasive surgically implanted therapy with real risks."

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Choriocapillaris changes emerge as an early marker in the diabetic spectrum

A study using swept-source OCT angiography found that macular microvascular impairment is detectable as early as the prediabetic stage, suggesting a role for choriocapillaris imaging in monitoring early metabolic disease. Participants with prediabetes showed lower vessel density and perfusion density in the superficial and deep capillary plexuses compared with controls.

Choriocapillaris flow-deficit density rose progressively across disease stages, from 9.3 plus or minus 0.9 in prediabetes to 9.7 plus or minus 1.1 in early diabetes of less than 3 years and 9.8 plus or minus 1.0 in diabetes of 3 to 7 years. Senior author Gavin SW Tan, MD, of the Singapore Eye Research Institute, and colleagues concluded that impairment involving both the retinal capillary plexuses and the choriocapillaris is present before clinical diabetes, positioning choriocapillaris status as a potential biomarker for early progression.

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