Key takeaways from an Oculis Holding AG-sponsored global initiative of leading retina and ophthalmology experts underscore a growing consensus regarding unmet needs in diabetic macular edema (DME) management.
The findings were unveiled during last week’s 2026 Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver, Colorado.
Let’s start with this global initiative.
Dubbed the DME Delphi AWARE study, the initiative established a global expert consensus of 25 experts in the retina and ophthalmic space.
- Their goal was two-fold: To develop a better understanding of the current DME landscape and to improve DME patient care.
How they did this: By answering three iterative anonymous surveys on:
- Unmet needs in DME patient management
- Disease detection and assessment
- Intervention considerations.
Talk more about these surveys.
Surveys 1 and 2 established consensus on the necessity of non-invasive DME treatments for DME.
Meanwhile, Survey 3 sought to establish directions for clinical decisions on statements that have, historically, been unable to achieve a consensus. Examples of these:
- Observations on retinal thickness
- Best-corrected visual acuity (BCVA) loss when considering treatment initiation
- Definitions of “poor” and "non-response” to treatment
Gotcha. So, what were the results from all three?
First, see here for interim findings from last year’s ARVO meeting.
As for this latest update: Based on response from 20 experts, the cumulative results from Surveys 1, 2, and 3 identified two major unmet needs for DME management:
- Novel therapies for concomitant use with current standard of care
- A necessity of therapeutic options to target early intervention
In fact, the third survey—which, take note, had a 100% completion rate—further reinforced the need for non-invasive therapies in cases where functional BCVA outcomes prompt intervention.
How strong was this reinforcement?
As reported by Baruch Kuppermann, MD, PhD, during ARVO:
- 70% (14/20) felt that a ≥1-line loss from 20/20 would prompt early intervention with a non-invasive treatment
- 5% (1/20) felt the same loss should prompt early intervention with intravitreal (IVT) treatment
How about in the case of a ≥2-line loss from 20/20?
The responses varied:
- 85% (17/20) felt that this should prompt early intervention for a non-invasive treatment
- 40% (8/20) felt the same loss should prompt early initiation of IVT treatment
Now for a closer look at this early intervention component.
The expert panel established two goals clinicians should work towards when the disease is still in its early stages: improving or stabilizing visual function and reducing inflammatory factors.
Also worth noting: They defined and differentiated the concept of “early intervention” from another stage in the (earlier) DME management process: “early detection”
… and the difference is?
Early intervention refers to the detection of DME patients prior to the presence of fluid, while early detection is the treatment of DME patients prior to functional deterioration.
Speaking of treatment: How was a “poor response” defined?
The panel reached a consensus on this by defining it as a reduction of <10% in retinal thickness from baseline central subfield thickness (CST) ≥350 µm.
Along these lines: 75% (15/20) agreed that, in addition to macular volume, the presence of intraretinal fluid is more important than the presence of subretinal fluid when assessing or defining retina thickening.
And the general takeaway from these results?
Similar to prior reportings on the DME AWARE Delphi panel, the latest findings spotlight critical clinical considerations for DME management—paticularly the “importance of non-invasive treatment options when considering early intervention for treatment of DME based on BCVA outcomes.”
Lastly, tie it back to Oculis’s involvement.
The panel’s identification of a need for a non-invasive DME treatment supports the global biopharmaceutical company’s ongoing advancement of its own asset: OCS-01.
- And wouldn’t you know it—this candidate is intended for a non-invasive (topical administration).
What to know: OCS-01 is a novel, high-concentration (15 mg/ml) formulation of dexamethasone that utilizes Oculis’ OPTIREACH solubilizing nanoparticle technology.
- See here for how the eye drop-formulated drug targets disease treatment.
What’s the latest clinical update on it?
As we last reported (just a few weeks ago), the final patient was dosed in the phase 3 DIAMOND-1 trial. Prior to this, Oculis shared positive topline data from stage 1 of the study in May 2023.
- Check it out here.
Looking ahead: Topline data from the study’s second stage is expected in June, followed by a potential new drug application (NDA) submission at the end of 2026.