Phase 3 Stage 1 DIAMOND Trial Results of Oculis' OCS-01 in DME Presented at Euretina

Oculis announced that Professor Ramin Tadayoni, MD, PhD, presented the positive results from stage 1 of the phase 3 DIAMOND trial of OCS-01 in patients with DME at the 23rd EURETINA congress in Amsterdam.

The data showed that the trial met primary and secondary endpoints with robust statistical significance, and achieved its objective of confirming the loading and maintenance dose to be tested in stage 2 of the trial. Specifically, the trial met its primary endpoint, showing a statistically significant improvement in best corrected visual acuity (BCVA) in patients treated with OCS-01 versus vehicle-treated patients at Week 6 (OCS-01: 7.2 letters vs vehicle: 3.1 letters, P=0.007), which was sustained through Week 12 (OCS-01: 7.6 letters vs vehicle: 3.7 letters, P=0.016).

For two secondary endpoints, a significantly higher percentage of patients treated with OCS-01 achieved ≥15-letter improvement in BCVA (OCS-01 25.3% vs vehicle: 9.8%, P=0.015), and patients in the OCS-01 treatment arm also showed significant improvement in retinal thickness as compared to vehicle (OCS-01: -63.6 µm vs vehicle: +5.5 µm, P < 0.0001). OCS-01 was well-tolerated with no unexpected adverse events observed. The positive results support the progression of the DIAMOND program, with two parallel 52-week global phase 3 trials. If approved, OCS-01 has the potential to become the first topical eye drop for the treatment of DME and address the current treatment gap by providing a noninvasive therapeutic option.

“The results from the DIAMOND phase 3 stage 1 trial are exciting and very meaningful for both clinicians and patients with DME, the leading cause of visual loss and legal blindness in patients with diabetes. Current injectable treatments are linked to a high treatment burden, therefore having a non-nvasive, topical treatment such as OCS-01 would represent a paradigm shift in how and when DME could be treated in the future," said Dr. Tadayoni, Professor of Ophthalmology, Université Paris Cité, France, and Department Head at Lariboisière, Saint Louis and Adolphe de Rothschild Foundation hospitals, and Co-chair of Oculis’ Scientific Advisory Board.

Riad Sherif, MD, Chief Executive Officer of Oculis, said the company remains on track to commence Stage 2 of the DIAMOND trial by the end of 2023.

OCS-01 is Oculis’ lead product candidate and the first investigational eye drop for both front and back of the eye indications, with positive topline results in stage 1 of the phase 3 DIAMOND trial for diabetic macular edema (DME) announced in May 2023, and positive topline phase 3 OPTIMIZE trial results for the treatment of inflammation and pain following cataract surgery announced in August 2023. Furthermore, the investigator-initiated LEOPARD study evaluating OCS-01 for treatment of cystoid macular edema (CME) enrolled its first patient in August 2023.

Leveraging Oculis’ proprietary Optireach technology, OCS-01 is a novel, high concentration (15 mg/ml), topical formulation of dexamethasone. It is developed to reach the retina via an eye drop, a route of administration for DME that is differentiated from currently available therapies, that are all invasive such as ocular implants or intravitreal injections to deliver the medication to the retina.