Oculis Accelerates Enrollment in both DIAMOND Phase 3 Trials of OCS-01 in Diabetic Macular Edema and Expands its DIAMOND Program Committees
Oculis Holding AG (Nasdaq: OCS) announces accelerated patient enrollment for both Phase 3 DIAMOND trials of OCS-01 eye drops in diabetic macular edema (DME). The DIAMOND-1 trial has enrolled ~70% of patients, while DIAMOND-2 has enrolled ~40%. The company has also expanded its DIAMOND program committees with globally renowned retina experts.
The DIAMOND program consists of two Phase 3, double-masked, randomized, multi-center trials evaluating the efficacy and safety of OCS-01 eye drops in DME patients. If approved, OCS-01 has the potential to be the first topical eye drop to treat DME, potentially transforming the treatment paradigm.
Dr. Arshad M. Khanani, DIAMOND Program Steering Committee Chairperson, highlighted promising results from Stage 1 of the DIAMOND Phase 3 program, showing significant improvements in visual acuity and clinically meaningful reduction in macular edema for patients treated with OCS-01.
Oculis Holding AG (Nasdaq: OCS) annuncia un'accelerazione nell'arruolamento dei pazienti per entrambe le sperimentazioni DIAMOND di Fase 3 relative alle gocce oculari OCS-01 per l'edema maculare diabetico (DME). La sperimentazione DIAMOND-1 ha arruolato circa il 70% dei pazienti, mentre la DIAMOND-2 ha arruolato circa il 40%. Inoltre, l'azienda ha ampliato i comitati del programma DIAMOND con esperti di retina di fama mondiale.
Il programma DIAMOND consiste in due prove di Fase 3, doppio cieco, randomizzate e multicentriche, che valutano l'efficacia e la sicurezza delle gocce oculari OCS-01 nei pazienti con DME. Se approvato, OCS-01 potrebbe diventare la prima goccia oculare topica per il trattamento del DME, trasformando potenzialmente il paradigma terapeutico.
Il Dr. Arshad M. Khanani, presidente del Comitato Direttivo del Programma DIAMOND, ha evidenziato risultati promettenti dalla Fase 1 del programma DIAMOND di Fase 3, mostrando miglioramenti significativi nell'acuità visiva e una riduzione clinicamente significativa dell'edema maculare per i pazienti trattati con OCS-01.
Oculis Holding AG (Nasdaq: OCS) anuncia un acelerado reclutamiento de pacientes para ambos ensayos de Fase 3 DIAMOND de las gotas oculares OCS-01 en edema macular diabético (DME). El ensayo DIAMOND-1 ha reclutado aproximadamente el 70% de los pacientes, mientras que el DIAMOND-2 ha reclutado alrededor del 40%. La compañía también ha ampliado sus comités del programa DIAMOND con expertos en retina de renombre mundial.
El programa DIAMOND consiste en dos ensayos de Fase 3, doble ciego, aleatorizados y multicéntricos que evalúan la eficacia y seguridad de las gotas oculares OCS-01 en pacientes con DME. Si se aprueba, OCS-01 podría convertirse en la primera gota ocular tópica para tratar el DME, transformando potencialmente el paradigma del tratamiento.
El Dr. Arshad M. Khanani, presidente del Comité Directivo del Programa DIAMOND, destacó resultados prometedores de la Fase 1 del programa DIAMOND de Fase 3, mostrando mejoras significativas en la agudeza visual y una reducción clínicamente significativa del edema macular en los pacientes tratados con OCS-01.
Oculis Holding AG (Nasdaq: OCS)는 당뇨병성 황반부종(DME)에 대한 OCS-01 점안액의 두 개의 3상 DIAMOND 시험에 대한 환자 등록을 가속화한다고 발표했습니다. DIAMOND-1 시험은 약 70%의 환자를 등록했으며, DIAMOND-2 시험은 약 40%의 환자를 등록했습니다. 또한, 이 회사는 세계적으로 유명한 망막 전문가들과 함께 DIAMOND 프로그램 위원회를 확장했습니다.
DIAMOND 프로그램은 DME 환자에서 OCS-01 점안액의 효능과 안전성을 평가하는 3상 이중 맹검 무작위 다센터 시험 두 개로 구성되어 있습니다. 만약 승인이 될 경우, OCS-01은 DME 치료를 위한 최초의 국소 점안액이 될 수 있으며, 치료 패러다임에 혁신을 가져올 가능성이 있습니다.
DIAMOND 프로그램 운영위원회 의장인 Dr. Arshad M. Khanani는 DIAMOND 3상 프로그램의 1단계에서 유망한 결과를 강조하며, OCS-01로 치료받은 환자들에게 시력 향상과 임상적으로 의미 있는 황반부종 감소가 있음을 보여주었습니다.
Oculis Holding AG (Nasdaq: OCS) annonce une accélération de l'enrôlement des patients pour les deux essais DIAMOND de phase 3 portant sur les gouttes oculaires OCS-01 dans le cas de l'œdème maculaire diabétique (DME). L'essai DIAMOND-1 a enrôlé environ 70 % des patients, tandis que le DIAMOND-2 a enregistré environ 40 % des patients. L'entreprise a également élargi ses comités du programme DIAMOND avec des experts en rétine de renommée mondiale.
Le programme DIAMOND comprend deux essais de phase 3, en double aveugle, randomisés et multicentriques, qui évaluent l'efficacité et la sécurité des gouttes oculaires OCS-01 chez les patients atteints de DME. Si elles sont approuvées, les OCS-01 pourraient devenir les premières gouttes oculaires topiques pour traiter le DME, transformant potentiellement le paradigme de traitement.
Le Dr Arshad M. Khanani, président du comité directeur du programme DIAMOND, a souligné les résultats prometteurs de la phase 1 du programme DIAMOND de phase 3, montrant des améliorations significatives de l'acuité visuelle et une réduction cliniquement significative de l'œdème maculaire chez les patients traités avec OCS-01.
Oculis Holding AG (Nasdaq: OCS) kündigt eine beschleunigte Rekrutierung von Patienten für beide Phase-3-DIAMOND-Studien der OCS-01-Augentropfen bei diabetischem Makulaödem (DME) an. In der Studie DIAMOND-1 wurden etwa 70 % der Patienten rekrutiert, während in der DIAMOND-2-Studie etwa 40 % der Patienten rekrutiert wurden. Das Unternehmen hat auch seine DIAMOND-Programmausschüsse mit weltweit anerkannten Experten für Netzhauterkrankungen erweitert.
Das DIAMOND-Programm besteht aus zwei Phase-3-Studien, die doppelt maskiert, randomisiert und multizentrisch durchgeführt werden und die Wirksamkeit und Sicherheit von OCS-01-Augentropfen bei DME-Patienten bewerten. Bei Genehmigung könnte OCS-01 das erste topische Augentropfen zur Behandlung von DME werden und so das Behandlungsparadigma potenziell revolutionieren.
Dr. Arshad M. Khanani, Vorsitzender des Lenkungsausschusses des DIAMOND-Programms, hob die vielversprechenden Ergebnisse aus Phase 1 des DIAMOND-Programms der Phase 3 hervor, die signifikante Verbesserungen der Sehschärfe und eine klinisch relevante Reduktion des Makulaödems bei Patienten zeigten, die mit OCS-01 behandelt wurden.
- Accelerated patient enrollment in both Phase 3 DIAMOND trials
- ~70% of patients enrolled in DIAMOND-1 trial
- ~40% of patients enrolled in DIAMOND-2 trial
- Expansion of DIAMOND program committees with renowned retina experts
- Promising Stage 1 results showing significant improvements in visual acuity and macular edema reduction
- None.
Insights
The acceleration of patient enrollment in Oculis' DIAMOND Phase 3 trials for OCS-01 in diabetic macular edema (DME) is a significant development. With ~70% enrollment in DIAMOND-1 and ~40% in DIAMOND-2, the company is making rapid progress towards completing these pivotal studies.
The potential of OCS-01 as the first topical eye drop for DME could be revolutionary. Current DME treatments often involve invasive injections, so a non-invasive option could greatly improve patient experience and potentially increase treatment adherence.
The expansion of the DIAMOND program committees with renowned retina experts adds credibility and expertise to the trials. This could enhance the quality of the study design and interpretation of results, potentially increasing the likelihood of regulatory approval if the data is positive.
While promising, it's important to note that Phase 3 results are still pending. Investors should monitor for efficacy and safety data, as well as any signals on potential market positioning against existing DME treatments.
Oculis' accelerated enrollment in the DIAMOND trials is a positive signal for investors, potentially shortening the timeline to potential commercialization. Faster enrollment could lead to earlier data readouts and, if positive, a quicker path to market.
The DME market is substantial, with millions affected worldwide. If approved, OCS-01 could capture a significant portion of this market, especially as a first-in-class topical treatment. This represents a considerable revenue opportunity for Oculis.
However, investors should consider that Oculis, with a market cap of
The expanded expert committee, while beneficial for the trial, also indicates ongoing R&D expenses. Investors should monitor cash burn rates and potential need for future financing as the trials progress.
Overall, this news suggests positive momentum in Oculis' lead program, which could drive investor interest and potentially impact stock performance in the near term.
- Phase 3 DIAMOND-1 and DIAMOND-2 trials enrollment of OCS-01 in diabetic macular edema (DME) accelerated with great momentum
- DIAMOND program committees expanded with globally renowned retina experts
- If approved, OCS-01 has the potential to transform the treatment paradigm as the first topical eye drop to treat DME
ZUG, Switzerland, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announces the acceleration of patient enrollment for both Phase 3 DIAMOND trials of OCS-01 eye drops in DME and expansion of the DIAMOND program committees with globally renowned retina experts.
Substantial enrollment progress was achieved since the end of Q2 2024 through early October, with ~
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: “I am honored to chair the DIAMOND steering committee, comprised of leading experts from around the globe, as we support the outstanding team at Oculis in the late-stage development of OCS-01. The results from Stage 1 of the DIAMOND Phase 3 program are promising, showing that patients treated with OCS-01 experienced significant improvements in visual acuity and a clinically meaningful reduction in macular edema. The DIAMOND program offers hope to the millions worldwide affected by DME, with OCS-01 potentially emerging as the first non-invasive topical eye drop therapy.”
Riad Sherif, M.D., Chief Executive Officer of Oculis, said: ”We are very pleased with the strong momentum in patient enrollment in DIAMOND-1 and DIAMOND-2 Phase 3 trials which continues to exceed our expectations. We are also honored to have such a distinguished and broad group of global experts on the expanded DIAMOND program committees and look forward to working with the committees and benefiting from their deep expertise as we advance the DIAMOND program.”
The DIAMOND program committees are comprised of world-renowned experts who provide strategic oversight as Oculis develops OCS-01 which has the potential to be the first topical eye drop to transform DME treatment paradigm:
- Arshad Khanani, M.D.
- David Almeida, M.D.
- Mark Barakat, M.D.
- Kirk Bateman, M.Sc.
- David Boyer, M.D.
- Margaret Chang, M.D.
- Saradha Chexal, M.D.
- Carl Danzig, M.D.
- Dilsher Dhoot, M.D.
- Diana Do, M.D.
- Frank Holz, M.D.
- Baruch D. Kuppermann, M.D.
- Timothy Lai, M.D.
- Anat Loewenstein, M.D.
- Sabri Markabi, M.D.
- Patricio Schlottmann, M.D.
- Ashish Sharma, M.D.
- Veeral Sheth, M.D.
- Michael Singer, M.D.
- Thomas Wolfensberger, M.D.
For more information about the DIAMOND program committee members, please visit oculis.com.
To learn more about the Phase 3 DIAMOND trials, please visit diamondtrial.com.
About OCS-01 eye drops and the OPTIREACH® technology
Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It was developed to treat the retina via an eye drop, a route of administration for DME that contrasts with currently available therapies, all requiring invasive delivery to reach the retina such as intravitreal injections or ocular implants. 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 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 that has not received regulatory approval for commercial use in any country.
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 aims to enroll 350 patients in each of these pivotal trials that will be 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, and both trials are currently enrolling.
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 safer, more effective, longer lasting, and less burdensome treatments for DME patients.
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 comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis’ goal is to improve the health and quality of life of patients worldwide. The company 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: oculis.com
(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
Oculis Contacts
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
1-212-915-2577
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 eye drop therapy for DME; the potential of OCS-01 to treat both front and back of the eye indications; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical trials, including the progress of Oculis’ DIAMOND Phase 3 program with OCS-01 in DME; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials, 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.
FAQ
What is the current enrollment status of Oculis' DIAMOND trials for OCS-01 (OCS)?
What is the potential impact of OCS-01 (OCS) in treating diabetic macular edema?
What were the results from Stage 1 of the DIAMOND Phase 3 program for OCS-01 (OCS)?
Who is chairing the DIAMOND program steering committee for Oculis (OCS)?
