Oculis (NASDAQ: OCS) OCS-01 DME Phase 3 miss shifts focus to other drugs

Rhea-AI Filing Summary

Oculis Holding reported topline Phase 3 results from its DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in diabetic macular edema. The primary endpoint of improved best corrected visual acuity at week 52 was not met in either study, and a key secondary visual endpoint also failed. Retinal thickness did show substantial and sustained reductions versus vehicle across most visits, and OCS-01 was generally well tolerated with no unexpected safety issues, although higher eye pressure and cataracts were more frequent with treatment. Based on these results, Oculis does not plan to seek FDA approval for OCS-01 in this indication and will refocus resources on its late-stage Privosegtor PIONEER program in optic neuropathies and the Licaminlimab PREDICT-1 trial in dry eye disease. The company highlighted a strong financial position with $278 million in cash, cash equivalents and short-term investments as of March 31, 2026, which it expects to fund operations into the second half of 2029.

Positive

• None.

Negative

• OCS-01 DME program setback: Both DIAMOND Phase 3 trials failed the primary visual acuity endpoint and the key ≥15-letter gain endpoint at Week 52, and Oculis does not plan to pursue an FDA filing for OCS-01 in diabetic macular edema.

Insights

Biopharma clinical-stage analyst

Phase 3 failure in DME ends OCS-01 path but late-stage pipeline remains funded.

The DIAMOND Phase 3 trials showed that OCS-01 did not improve best corrected visual acuity versus vehicle at Week 52, and the ≥15-letter responder endpoint was also not met. This effectively removes OCS-01 in diabetic macular edema from Oculis’ near-term regulatory path.

Despite this, OCS-01 produced rapid, substantial and sustained reductions in central subfield retinal thickness with favorable p-values, and safety was generally consistent with steroid use, including more elevated intraocular pressure and cataracts. These anatomy gains without matching vision benefit limit regulatory viability in DME.

Management states it does not plan an FDA filing for OCS-01 in DME and will focus resources on the Privosegtor PIONEER program in optic neuropathies and the Licaminlimab PREDICT-1 trial in dry eye disease. With $278 million in cash and equivalents as of March 31, 2026, Oculis guides cash runway into 2H 2029, supporting continued late-stage development despite this setback.

Key Figures

Cash and equivalents: $278 million Cash runway: into 2H 2029 BCVA change DIAMOND-1: 1.2 vs 5.1 letters +4 more

7 metrics

Cash and equivalents $278 million Cash, cash equivalents and short-term investments as of March 31, 2026

Cash runway into 2H 2029 Company-stated funding horizon based on March 31, 2026 cash balance

BCVA change DIAMOND-1 1.2 vs 5.1 letters Mean change in BCVA at Week 52, OCS-01 vs vehicle in DIAMOND-1

BCVA change DIAMOND-2 4.6 vs 5.2 letters Mean change in BCVA at Week 52, OCS-01 vs vehicle in DIAMOND-2

CST change DIAMOND-1 -51.8 vs -31.7 µm Mean change in central subfield thickness at Week 52, OCS-01 vs vehicle

CST change DIAMOND-2 -64.3 vs -18.8 µm Mean change in central subfield thickness at Week 52, OCS-01 vs vehicle

DIAMOND enrollment over 800 patients Total patients enrolled across DIAMOND-1 and DIAMOND-2 Phase 3 trials

Key Terms

diabetic macular edema, best corrected visual acuity, central subfield thickness, registrational program, +2 more

6 terms

diabetic macular edema medical

"OCS-01 eye drops in patients with diabetic macular edema (DME)."

Diabetic macular edema is an eye condition in which fluid leaks into and swells the macula, the part of the retina used for sharp, central vision, often as a complication of diabetes. For investors it matters because it drives demand for medicines, medical devices and eye-care services, influences clinical trial and regulatory outcomes, and can affect healthcare costs and revenue forecasts—think of the macula as the camera’s central lens that becomes blurred when it soaks up excess fluid.

best corrected visual acuity medical

"The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52, was not met"

Best corrected visual acuity (BCVA) is the sharpest level of sight a person can reach when using the optimal prescription lenses or other standard corrections, typically measured with an eye chart. For investors, BCVA is a common, standardized outcome in trials and product tests—like checking a camera’s clarity after fine-tuning—so changes in BCVA signal whether an eye treatment or device is delivering real, measurable benefit.

central subfield thickness medical

"Mean Change in CST from Baseline at Week 52 OCS-01: -51.8 µm Vehicle: -31.7 µm"

Central subfield thickness is a measurement of the retina’s thickness at the very center of the macula, typically taken by an imaging scan of the eye; think of it like measuring the height of the ground at the center of a small target. It matters to investors because changes in this number are a common, objective medical endpoint used to judge whether eye drugs or devices relieve swelling and improve vision, which influences regulatory approval, market potential, and sales forecasts.

registrational program financial

"Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans"

A registrational program is the set of late-stage clinical studies and regulatory steps designed to show that a drug or medical product is safe and effective enough to win formal approval from health authorities. Think of it like the final licensing exams a product must pass before it can be sold widely; investors watch these programs closely because successful results clear the way to market access, revenue potential, and lower regulatory risk, while failures can halt commercial plans.

dry eye disease medical

"Licaminlimab PREDICT-1 registrational trial in dry eye disease (DED)."

Dry eye disease is a chronic condition where the eyes do not make enough tears or the tears evaporate too quickly, causing irritation, blurred vision and sensitivity to light — imagine having tiny grains of sand or a windshield with streaks that never clear. It matters to investors because it creates steady demand for prescription drugs, medical devices and diagnostic tests; treatments can be long‑term, subject to regulatory approval and insurance coverage, and successful products can capture large, recurring revenue streams.

Phase 3 medical

"two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

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Form 6-K: How Foreign Companies Report to the SEC →

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the Month of May 2026

(Commission File No. 001-41636)

Oculis Holding AG

(Translation of registrant's name into English)

Bahnhofstrasse 20

CH-6300

Zug, Switzerland

(Address of registrant’s principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On May 29, 2026, Oculis Holding AG (the “Registrant”) announced topline data from its DIAMOND Phase 3 trials of OCS-01 for the treatment of diabetic macular edema and held a conference call to discuss the results. The press release and the corporate presentation presented during the conference call are furnished hereto as Exhibits 99.1 and 99.2, respectively.

Exhibits 99.1 and 99.2 are hereby incorporated by reference into the Registrant’s Registration Statements on Form S-8 (File No. 333-271938 and 333-287806) and Form F-3 (File Nos. 333-294011, 333-278409, 333-271063 and 333-291426).

EXHIBIT INDEX

Exhibit		Description
99.1		Press Release dated May 29, 2026
99.2		Corporate Presentation dated May 29, 2026

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

				OCULIS HOLDING AG
Date: May 29, 2026				By:		/s/ Sylvia Cheung
						Sylvia Cheung Chief Financial Officer

Exhibit 99.1

Oculis Announces Topline Results from DIAMOND Phase 3 Trials with OCS-01 in Diabetic Macular Edema

•The primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 in both Phase 3 trials was not met

•The secondary endpoint of retinal thickness showed a substantial and persistent reduction with OCS-01 vs vehicle in both trials

•Oculis will focus its developmental efforts and financial resources on the ongoing Privosegtor PIONEER registrational program in optic neuropathies and the Licaminlimab PREDICT-1 registrational trial in dry eye disease

•Financial position remains strong with $278 million in cash, cash equivalents, and short-term investments as of March 31, 2026, providing cash runway into 2H 2029

Conference call today at 4:30 pm ET

ZUG, Switzerland, 29 May, 2026 – Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (Oculis), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced topline results from its Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in patients with diabetic macular edema (DME).

The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consisted of two Phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52 weeks of treatment. Over 800 patients were enrolled across both pivotal trials at 119 investigational sites throughout the United States and several other countries.

The primary endpoint, mean change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52, was not met in both trials. The secondary endpoint of retinal thickness, as measured by OCT, showed a substantial and persistent reduction with OCS-01 vs vehicle at all visits in DIAMOND-2 and at all visits except Week 52 in DIAMOND-1. The key secondary endpoint of the proportion of patients with ≥15-letter gain in BCVA was not met in both trials.

OCS-01 was well tolerated, with no unexpected adverse events observed, and the overall safety profile was consistent with that of previous trials.

Based on the results, at this time, Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME.

Riad Sherif, M.D., Chief Executive Officer of Oculis, said: “We are naturally disappointed that the substantial and sustained reduction in retinal thickness observed across both trials didn’t translate into BCVA improvement at week 52. In these two trials, our team partnered with 119 global sites across multiple countries and demonstrated excellent execution. We thank the patients, investigators, and all

Exhibit 99.1

clinical experts who participated in the DIAMOND program. Our strong financial position allows us to execute on our robust late-stage development portfolio. While we finalize the review of DIAMOND program data, we will strategically focus resources on advancing our late-stage portfolio, including the Privosegtor platform, starting with the PIONEER program for Privosegtor in optic neuropathies, and the PREDICT-1 trial for Licaminlimab to drive precision medicine in dry eye disease.”

Analyst and investor call

The Oculis management team will host an analyst and investor call today at 4:30 pm U.S. Eastern Time, to review the topline results and provide a pipeline update. Interested parties may participate in the call via the following webcast link:

https://viavid.webcasts.com/starthere.jsp?ei=1765661&tp_key=0d6c454cfe

Or use the following dial-in options:
US-based Investors: 1-877-407-4018
International Investors: 1-201-689-8471
Conference ID: 13760937

A replay of the webcast and accompanying slides will be available for 90 days following the event through the “Events and Presentations” page of the “Investors and Media” section of the company’s website.

- ENDS -

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neurological diseases. Licaminlimab is a novel, topical anti-TNFα in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.

For more information, please visit: www.oculis.com

Oculis Contact

Ms. Sylvia Cheung, CFO

sylvia.cheung@oculis.com

Exhibit 99.1

Investor Relations

LifeSci Advisors

Corey Davis, Ph.D.

cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; and Oculis’ cash runway are forward-looking. The clinical trial results presented in this press release are topline and preliminary and subject to change, as analysis is ongoing. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the SEC. Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

OCS-01Phase 3 DIAMOND TrialsTopline Results in DME May 29, 2026

These slides and the accompanying oral presentation contain forward-looking statements and information. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. For example, all statements we make regarding our regulatory and development plans for OCS-01 in diabetic macular edema or other indications, the timing, progress and regulatory strategy for our other research and development programs, our cash runway and statements about the potential therapeutic effects of our product candidates are forward-looking. All forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain. The clinical trial results presented in this presentation are topline and preliminary and subject to change, as analysis is ongoing. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the possibility that Oculis may be adversely affected by economic, business, and/or competitive factors; Oculis' estimates of expenses and profitability; Oculis' ability to develop, manufacture and commercialize the product candidates in its pipeline; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; the ability of Oculis or its partners to enroll and retain patients in clinical studies; the ability of Oculis or its partners to gain approval from regulators for planned clinical studies, study plans or sites; Oculis' ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; the success of Oculis' current and future collaborations, joint ventures, partnerships or licensing arrangements; financial position, strategy and anticipated milestones; and other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Oculis may from time to time file or furnish with the SEC. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Cautionary note on forward-looking statements Copyright of this presentation is owned by Oculis. No part of this presentation may be reproduced in any manner without the permission of Oculis. Safe Harbor Statements

Phase 3 DIAMOND Program Topline Results Summary At this time, Oculis does not plan to pursue FDA regulatory filing with OCS-01 for DME DIAMOND-1 DIAMOND-2 Visual function: Primary endpoint not met Mean Change in BCVA from Baseline at Week 52 OCS-01: 1.2 letters Vehicle: 5.1 letters OCS-01: 4.6 letters Vehicle: 5.2 letters Retinal anatomy: Rapid and sustained reduction Mean Change in CST from Baseline at Week 52 OCS-01: -51.8 µm Vehicle: -31.7 µm OCS-01: -64.3 µm Vehicle: -18.8 µm Safety OCS-01 was well tolerated with no unexpected safety findings

Study Design and Patient Population

OCS-01 | Phase 3 DIAMOND Program in DME BCVA: best corrected visual acuity; CST: central subfield thickness; DME: diabetic macular edema; ETDRS: Early Treatment Diabetic Retinopathy Study; VEGF: vascular endothelial growth factor. Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema. ClinicalTrials.gov identifier: NCT05066997 Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2). ClinicalTrials.gov identifier: NCT06172257 Evaluate the safety and efficacy of OCS-01 vs vehicle for the treatment of DME in two adequate and well-controlled global Phase 3 clinical trials Age 18-85 years Confirmed diagnosis of DME Diabetes mellitus 1 and 2 ETDRS BCVA letter score: 65-24 Retinal thickness (CST) ≥ 310 µm Primary endpoint: Change in BCVA ETDRS letter score at Week 52 Key secondary endpoint: % with a ≥ 15 ETDRS letter gain in BCVA at Week 52 CST change vs Baseline Objective Endpoints Study Population Screening OCS-01 Vehicle End of trial Randomization 1:1 46 weeks Maintenance Phase 3x/day 6 weeks Induction Phase 6x/day

ITT Population Diamond Patient Disposition AE: adverse event; ITT: intention-to-treat. DIAMOND-1 DIAMOND-2 Screen failures n=285 OCS-01 n=200 Vehicle n=203 Completed 52 weeks n=164 Completed 52 weeks n=163 Discontinued study Withdrawn: n=19 AE: n=9 Lost to follow-up: n=12 Other: n=0 Discontinued study Withdrawn: n=12 AE: n=13 Lost to follow-up: n=10 Other: n=1 Randomized n=404 Screened n=689 Screen failures n=312 OCS-01 n=200 Vehicle n=201 Completed 52 weeks n=168 Completed 52 weeks n=168 Discontinued study Withdrawn: n=13 AE: n=8 Lost to follow-up: n=5 Other: n=7 Discontinued study Withdrawn: n=11 AE: n=7 Lost to follow-up: n=9 Other: n=5 Randomized n=401 Screened n=713 1 patient randomized, not dosed

DIAMOND-1 DIAMOND-2 Parameter OCS-01 (N=200) Vehicle (N=203) OCS-01 (N=200) Vehicle (N=201) Age, mean years (SD) 63.5 (9.77) 64.2 (9.57) 65.0 (8.68) 64.7 (8.33) Sex, n (%) Male Female 120 (60.0)80 (40.0) 111 (54.7)92 (45.3) 113 (56.5)87 (43.5) 108 (53.7)93 (46.3) Duration of DME, mean months (SD) 21.95 (33.866) 25.20 (34.352) 23.62 (32.916) 24.16 (40.082) BCVA, mean ETDRS letter score (SD) 58.2 (7.37) 57.8 (8.02) 57.2 (9.21) 57.2 (7.62) CST, mean µm (SD) 458.8 (117.35) 453.4 (128.22) 457.9 (145.77) 466.0 (147.83) IOP, mean mm Hg (SD) 14.8 (2.95) 14.9 (3.08) 14.6 (2.95) 14.6 (2.78) Treatment status, n (%) Naïve Previously-treated 109 (54.5)91 (45.5) 102 (50.2)101 (49.8) 101 (50.5)99 (49.5) 97 (48.3)104 (51.7) Lens status, n (%) * Phakic Pseudo phakic 125 (62.5)75 (37.5) 128 (63.1)75 (36.9) 119 (59.5)80 (40.0) 118 (58.7)83 (41.3) ITT Population Diamond Baseline Demographics BCVA: best corrected visual acuity; CST: central subfield thickness; DME: diabetic macular edema; ETDRS: Early Treatment Diabetic Retinopathy Study; ITT: intention-to-treat; SD: standard deviation. *1 patient in DIAMOND-2 OCS-01 arm was aphakic

Efficacy

Mean Change in CST, Baseline to Week 52 CST: central subfield thickness; ITT: intention-to-treat; LS: least squares; SE: standard error. Mean Change in CST Baseline to Week 52 DIAMOND-1 ITT Population 1 6 12 18 30 24 36 42 48 52 0 P <0.0001 P <0.0001 P <0.0001 P <0.0001 P <0.0001 P <0.0001 P =0.0013 P =0.0023 P =0.0396 P NS

Mean Change in CST, Baseline to Week 52 CST: central subfield thickness; ITT: intention-to-treat; LS: least squares; SE: standard error. Mean Change in CST Baseline to Week 52 DIAMOND-2 ITT Population 1 6 12 18 30 24 36 42 48 52 0 P <0.0001 P <0.0001 P <0.0001 P <0.0001 P <0.0001 P =0.0002 P <0.0001 P <0.0001 P <0.0001 P=0.0016

ITT Population BCVA: best corrected visual acuity; CI: confidence interval; ETDRS: Early Treatment Diabetic Retinopathy Study; ITT: intention-to-treat; LS: least squares; SE: standard error. Visual Function: Primary Endpoint Mean Change in BCVA from Baseline at Week 52 Mean Change in BCVA from Baseline at Week 52 DIAMOND-1 Mean Change in BCVA from Baseline at Week 52 DIAMOND-2 P value NS P value NS

ITT Population BCVA: best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ITT: intention-to-treat. Visual Function: Key Secondary Endpoint ≥15-Letter Gain in BVCA at Week 52 ≥15-Letter Gain from Baseline at Week 52 DIAMOND-1 ≥15-Letter Gain from Baseline at Week 52 DIAMOND-2 P value NS P value NS

Safety

Safety Summary OCS-01 was well tolerated, with no unexpected adverse events observed. Overall safety profile was consistent with that of previous trials. As expected, elevated IOP and cataracts were higher in the OCS-01 treated patients in line with chronic use of steroid in DME.

Summary

OCS-01 DIAMOND TLR Summary and Pipeline Prioritization Despite showing a rapid, substantial and sustained reduction in retinal thickness in patients treated with OCS-01, primary (mean change in BCVA) and key secondary (≥15-letter gainers) endpoints for both trials were not met at Week 52. Based on the results, at this time Oculis does not plan to pursue an FDA regulatory filing for OCS-01 in DME. Oculis will strategically focus resources on advancing our late-stage portfolio, including the Privosegtor platform, starting with the PIONEER program for Privosegtor in optic neuropathies, and the PREDICT-1 trial for Licaminlimab to drive precision medicine in dry eye disease. Financial position remains strong with $278 million in cash, cash equivalents, and short-term investments as of March 31, 2026, providing cash runway into 2H 2029.

Q&A

FAQ

What did Oculis (OCS) report about the OCS-01 DIAMOND Phase 3 trials in DME?

Oculis reported topline results showing that OCS-01 failed to meet the primary visual acuity endpoint and a key ≥15-letter gain endpoint at week 52 in both DIAMOND Phase 3 trials in diabetic macular edema, despite meaningful retinal thickness reductions.

Did OCS-01 improve vision outcomes in Oculis’ DIAMOND Phase 3 DME studies?

No, OCS-01 did not significantly improve best corrected visual acuity at week 52 compared with vehicle in either DIAMOND-1 or DIAMOND-2. The key secondary endpoint measuring the proportion of patients gaining at least 15 ETDRS letters in vision was also not met in both trials.

How did OCS-01 affect retinal thickness in the DIAMOND DME trials?

OCS-01 produced substantial and persistent reductions in central subfield thickness versus vehicle across visits. At week 52, mean retinal thickness reductions were larger with OCS-01 than vehicle in both DIAMOND-1 and DIAMOND-2, with statistically significant differences at most assessed time points.

Will Oculis pursue FDA approval for OCS-01 in diabetic macular edema?

Oculis currently does not plan to pursue an FDA regulatory filing for OCS-01 in diabetic macular edema. This decision is based on DIAMOND-1 and DIAMOND-2 failing to meet the primary visual acuity endpoint and the key ≥15-letter responder endpoint at week 52, despite anatomical improvements.

What is Oculis (OCS) focusing on after the OCS-01 DME trial results?

After these results, Oculis plans to focus development and financial resources on its late-stage pipeline. This includes the Privosegtor PIONEER registrational program for optic neuropathies and the Licaminlimab PREDICT-1 registrational trial, which uses a genotype-based approach in dry eye disease.

What is Oculis’ cash position and runway after the DIAMOND Phase 3 outcome?

Oculis reported a strong financial position with $278 million in cash, cash equivalents and short-term investments as of March 31, 2026. The company states this cash balance provides runway into the second half of 2029, supporting continued advancement of its late-stage clinical portfolio.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 30.6 KB
• EX-99.2 EX-99.2 14.3 KB