The Phase 3 DIAMOND trial of OCS-01 in Diabetic Macular Edema (DME) presents encouraging results, meeting primary and secondary endpoints.
Ramin Tadayoni, MD, PhD, presented positive results from Stage 1 of the Phase 3 DIAMOND trial of OCS-01 in patients with DME on behalf of Oculis at the 23rd EURETINA congress in Amsterdam.
In a press release from Oculis,1 the company shared that Tadayoni presented data showing 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.
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).1
For 2 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).1
Tadayoni commented on the results saying, “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-invasive, topical treatment such as OCS-01 would represent a paradigm shift in how and when DME could be treated in the future.”
Riad Sherif, MD, CEO of Oculis, also stated “We are honored that results from the DIAMOND Phase 3 Stage 1 trial of OCS-01 were selected as a late-breaking abstract for presentation at EURETINA, one of the top global congresses for cutting-edge retina science. We are committed to advancing sight saving treatments such as OCS-01 and remain on track to commence Stage 2 of the DIAMOND trial by the end of 2023.”
According to the company, OCS-01 is Oculis’ lead product candidate and the first investigational eye drop for both front and back of the eye indications.1