Oculis Completes Enrollment in both DIAMOND Phase 3 Trials of OCS-01 in Diabetic Macular Edema
Oculis (Nasdaq: OCS) has completed enrollment for its Phase 3 DIAMOND trials evaluating OCS-01 eye drops in diabetic macular edema (DME). The program consists of two double-masked, randomized, multi-center trials with over 800 patients across 119 sites globally.
The DIAMOND (DIAbetic Macular edema patients ON a Drop) program represents the first-ever pivotal trial for a topical DME treatment. Topline data is expected in Q2 2026, followed by an NDA submission. If approved, OCS-01 would become the first topical eye drop treatment for DME, addressing unmet needs for early intervention and patients with inadequate anti-VEGF therapy response.
Oculis (Nasdaq: OCS) ha completato l'arruolamento per i suoi studi di Fase 3 DIAMOND che valutano le gocce oculari OCS-01 nel trattamento dell'edema maculare diabetico (DME). Il programma consiste in due studi multicentrici, randomizzati e in doppio cieco, con oltre 800 pazienti distribuiti in 119 siti a livello globale.
Il programma DIAMOND (Pazienti con edema maculare diabetico in terapia con gocce) rappresenta il primo studio cruciale mai realizzato per un trattamento topico del DME. I dati preliminari sono attesi nel secondo trimestre del 2026, seguiti da una richiesta di approvazione (NDA). Se approvato, OCS-01 diventerà il primo trattamento topico a base di gocce oculari per il DME, rispondendo a esigenze insoddisfatte per un intervento precoce e per pazienti con risposta inadeguata alla terapia anti-VEGF.
Oculis (Nasdaq: OCS) ha completado la inscripción para sus ensayos de Fase 3 DIAMOND que evalúan las gotas oculares OCS-01 en el edema macular diabético (DME). El programa consiste en dos ensayos multicéntricos, aleatorizados y a doble ciego con más de 800 pacientes en 119 sitios a nivel mundial.
El programa DIAMOND (Pacientes diabéticos con edema macular en tratamiento con gotas) representa el primer ensayo pivotal para un tratamiento tópico del DME. Se esperan datos preliminares en el segundo trimestre de 2026, seguidos de una solicitud de NDA. Si se aprueba, OCS-01 se convertiría en el primer tratamiento tópico en forma de gotas para el DME, abordando necesidades no satisfechas para intervención temprana y pacientes con respuesta inadecuada a la terapia anti-VEGF.
Oculis (Nasdaq: OCS)는 당뇨병성 황반부종(DME) 치료를 위한 OCS-01 안약의 3상 DIAMOND 시험에 대한 등록을 완료했습니다. 이 프로그램은 전 세계 119개 사이트에서 800명 이상의 환자를 대상으로 하는 이중 맹검, 무작위 배정 다기관 시험으로 구성되어 있습니다.
DIAMOND (당뇨병성 황반부종 환자에게 안약 투여) 프로그램은 국소 DME 치료를 위한 최초의 중요한 시험을 나타냅니다. 주요 데이터는 2026년 2분기에 예상되며, 그 후 NDA 제출이 이루어질 예정입니다. 승인이 이루어질 경우, OCS-01은 DME에 대한 최초의 국소 안약 치료제가 되어 조기 개입 및 불충분한 항-VEGF 요법 반응을 보이는 환자들의 unmet needs를 해결하게 됩니다.
Oculis (Nasdaq: OCS) a terminé l'inscription pour ses essais de Phase 3 DIAMOND évaluant les gouttes oculaires OCS-01 dans l'œdème maculaire diabétique (DME). Le programme se compose de deux essais multicentriques, randomisés et en double aveugle, impliquant plus de 800 patients répartis sur 119 sites dans le monde.
Le programme DIAMOND (Patients diabétiques souffrant d'œdème maculaire sous traitement par gouttes) représente le premier essai pivot pour un traitement topique du DME. Les données préliminaires sont attendues au deuxième trimestre 2026, suivies d'une soumission de NDA. Si approuvé, OCS-01 deviendrait le premier traitement topique sous forme de gouttes pour le DME, répondant à des besoins non satisfaits pour une intervention précoce et pour les patients ayant une réponse inadéquate à la thérapie anti-VEGF.
Oculis (Nasdaq: OCS) hat die Rekrutierung für seine Phase-3-Studien DIAMOND abgeschlossen, die die Augentropfen OCS-01 bei diabetischem Makulaödem (DME) bewerten. Das Programm besteht aus zwei doppelblinden, randomisierten, multizentrischen Studien mit über 800 Patienten an 119 Standorten weltweit.
Das DIAMOND (Diabetiker mit Makulaödem unter Tropfen) Programm stellt die erste entscheidende Studie für eine topische DME-Behandlung dar. Die vorläufigen Daten werden im 2. Quartal 2026 erwartet, gefolgt von einer NDA-Einreichung. Bei Genehmigung würde OCS-01 die erste topische Augentropfenbehandlung für DME werden und damit unerfüllte Bedürfnisse für eine frühzeitige Intervention und Patienten mit unzureichender Reaktion auf die Anti-VEGF-Therapie ansprechen.
- First-ever topical eye drop treatment for DME in Phase 3 trials
- Successful enrollment of over 800 patients ahead of schedule
- Potential to address significant unmet medical need in DME treatment
- Strong investigator interest and rapid trial enrollment indicate market demand
- NDA submission and potential approval still at least 1 year away
- Clinical efficacy data not yet available until Q2 2026
Insights
The completion of enrollment in both DIAMOND Phase 3 trials for OCS-01 represents a significant milestone in potentially transforming DME treatment. Currently, DME patients rely primarily on invasive anti-VEGF injections directly into the eye, creating a substantial burden for the approximately 21 million patients worldwide.
What makes this development particularly noteworthy is that OCS-01 would be the first topical eye drop treatment for DME if approved—a paradigm shift in treatment approach. The successful enrollment of over 800 patients across 119 sites demonstrates both strong investigator interest and patient need for less-invasive alternatives.
The reference to "positive results seen in Stage 1" of the DIAMOND program suggests preliminary efficacy, though full validation awaits the Phase 3 results. Importantly, OCS-01 could address two critical unmet needs: providing an earlier, non-invasive intervention option and offering an alternative for patients with inadequate response to anti-VEGF therapy—potentially expanding the treatable patient population.
The rapid enrollment pace indicates strong clinical interest, which often correlates with perceived potential benefit. However, investors should understand that the Q2 2026 data readout timeline means commercial impact remains at least 2-3 years away, assuming positive trial results and subsequent regulatory approval.
Completing enrollment in both Phase 3 DIAMOND trials represents a significant de-risking event for Oculis. The company has demonstrated strong operational execution by rapidly enrolling over 800 patients across 119 sites, predominantly in the competitive US clinical trial landscape—often one of the most challenging aspects of late-stage development.
This milestone keeps Oculis on track for the projected Q2 2026 topline data readout, maintaining their critical path to potential commercialization. For a company with a
OCS-01's potential as a first-in-class topical treatment for DME represents a significant commercial opportunity. The current standard of care involves regular eye injections—a treatment paradigm ripe for disruption with a non-invasive alternative. While the reference to positive Stage 1 results is encouraging, the full commercial potential remains contingent on Phase 3 efficacy and safety outcomes.
From an investment perspective, this enrollment completion reduces timeline uncertainty but doesn't eliminate the primary risk of clinical trial results. With data readout approximately one year away and potential approval thereafter, OCS-01 represents a medium-term value driver that has successfully cleared an important developmental hurdle, positioning Oculis to potentially deliver the first topical therapy in this indication.
ZUG, Switzerland, April 10, 2025 (GLOBE NEWSWIRE) --
- DIAMOND is the first and only pivotal trial program ever conducted with a topical treatment for diabetic macular edema (DME)
- Over 800 patients randomized in DIAMOND-1 or DIAMOND-2 Phase 3 trials at an industry-leading record speed across 119 sites worldwide primarily in the US; topline data readout expected in Q2 2026 with NDA submission to follow
- Company to provide an update on the DIAMOND program and its innovative late-stage pipeline at the upcoming in-person and virtual R&D Day on Tuesday, April 15
Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced that it has completed enrollment in both Phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the U.S. Food and Drug Administration (FDA). The trials enrolled over 800 patients at 119 investigative sites throughout the United States and several other countries.
Rapid completion of enrollment in the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, consisting of two (2) 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, is an important milestone. Topline data from both Phase 3 trials is expected in the second quarter of 2026, with NDA submission to follow thereafter.
If approved, OCS-01 is expected to become the first topical eye drop for the treatment of DME and address unmet medical needs for early treatment intervention or for patients with inadequate response to anti-VEGF therapy.
Riad Sherif, M.D., Chief Executive Officer of Oculis, said: “The completion of enrollment in both the DIAMOND-1 and DIAMOND-2 Phase 3 trials shows strong focus on disciplined execution. I would like to thank all stakeholders participating in the trials and the whole medical community for their excellent support to advance this program towards NDA submission, which keeps us on track for a topline data readout from both studies in the second quarter of 2026. For the months to come, we will remain focused on execution to ensure the program's continued advancement, bringing us closer to potentially providing a transformational solution, with the first non-invasive topical eye drop therapy, for patients suffering from DME.”
Arshad M. Khanani, M.D., M.A, FASRS, DIAMOND Program Steering Committee Chairperson, Oculis Board of Directors member, Scientific Advisory Board Chair of Retina and Director of Clinical Research at Sierra Eye Associates, commented: “Together with my colleagues on the DIAMOND steering committee, I am greatly encouraged by the ongoing strong progress of OCS-01 and the Phase 3 program. It’s exciting to witness the enthusiasm from the investigators due to the positive results seen in Stage 1 of the DIAMOND program. The rapid enrollment of over 800 patients in both trials not only reflects the recognition among investigators of OCS-01's significant potential as an effective, non-invasive therapy for DME, but also demonstrates the high level of patient interest in a topical eye drop treatment.”
An update on the progress of the Phase 3 DIAMOND-1 and DIAMOND-2 trials will be included in Oculis’ upcoming in-person and virtual R&D Day on Tuesday April 15. Register for the event here.
To learn more about the Phase 3 DIAMOND trials, please visit diamondtrial.com.
-ENDS-
About OCS-01 eye drops and OPTIREACH® technology
Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and could be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye. Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option.
OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country.
About Diabetic Macular Edema (DME)
DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 20401,2. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients.
About the Phase 3 DIAMOND Program of OCS-01 in Diabetic Macular Edema
The DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) and DIAMOND-2 trials are Phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME. Oculis has enrolled over 800 patients across both pivotal trials who have been randomized 1:1 to receive OCS-01 or vehicle six times daily for the 6-week induction phase and then three times daily through week 52 for the maintenance phase. The primary endpoint is change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52. Secondary endpoints include percentage of patients with ≥15-letter gain in BCVA and change in central subfield thickness (CST), both at Week 52. Both trials were initiated upon the positive findings from stage 1 of the DIAMOND program, which was announced in the second quarter of 2023.
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
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 OCS-01, including patient impact and market opportunity; the potential of OCS-01 to become the first non-invasive topical eye drop therapy for DME; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical trials, including the progress of Oculis’ DIAMOND Phase 3 trials of OCS-01 eye drops in DME and the topline data readout from both Phase 3 trials expected in the second quarter of 2026; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; and the timing or likelihood of regulatory filings and approvals, are forward-looking. 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 U.S. Securities and Exchange Commission (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.
(1) Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564
(2) International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045
FAQ
When will Oculis (OCS) release topline data for the DIAMOND Phase 3 trials?
How many patients are enrolled in Oculis (OCS) DIAMOND Phase 3 trials for DME?
What makes OCS-01 unique in the treatment of diabetic macular edema?
What is the duration of treatment in the Oculis (OCS) DIAMOND Phase 3 trials?
