Oculis Holding Accelerates Enrollment in Both DIAMOND Phase 3 Trials of OCS-01

Oculis Holding Accelerates Enrollment in Both DIAMOND Phase 3 Trials of OCS-01

By, Admin 23 October 2024

Oculis Holding accelerates enrollment in both DIAMOND phase 3 trials of OCS-01 in diabetic macular edema

Overview

Oculis Holding AG (Oculis), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces the acceleration of patient enrollment for both phase 3 DIAMOND trials of OCS-01 eye drops in DME and expansion of the DIAMOND programme committees with globally renowned retina experts.

Enrollment time & Other Details 

  • Substantial enrollment progress was achieved since the end of Q2 2024 through early October, with ~70% of patients enrolled in the phase 3 DIAMOND-1 trial, and ~40% of patients enrolled in the phase 3 DIAMOND-2 trial. 
  • The DIAMOND (DIAbetic Macular edema patients ON a Drop) program consists of two (2) phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME.

Statement from Mr. Arshad M. Khanani

  • Arshad M. Khanani, M.D., M.A, FASRS, DIAMOND Programme 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 honoured 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 programme 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 programme offers hope to the millions worldwide affected by DME, with OCS-01 potentially emerging as the first non-invasive topical eye drop therapy.

Words from the CEO: Oculis

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 honoured to have such a distinguished and broad group of global experts on the expanded DIAMOND programme committees and look forward to working with the committees and benefiting from their deep expertise as we advance the DIAMOND programme.

DIAMOND Programme Committee Members

The DIAMOND programme 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.

About the Current OPTIREACH Formulation: OCS-01

  • 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.

DIAMOND-1 & Diamond 2 trials 

  • 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. 
  • 1ry endpoint- The primary endpoint is change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52.
  • 2nd endpoint- 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 programme, which was announced in the second quarter of 2023, and both trials are currently enrolling.

About 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 2040. 
  • 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 the Company: Oculis

  • Oculis is a global biopharmaceutical company 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-TNFa 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 US 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.

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