Oculis Provides Updates on Late-Stage Clinical Trials; Announces Leadership Appointments
Oculis provided updates its late-stage clinical trials, and also announced senior appointments to its management and advisory teams. The announcements were made during it R&D Day on Wednesday, February 28.
“2024 promises to be another exciting year for Oculis as we advance our late-stage clinical development programs. We have met two important clinical milestones with the rapid completion of enrollment in the phase 2b RELIEF trial of OCS-02 in dry eye disease (DED) and the initiation of the second phase 3 trial of OCS-01 in diabetic macular edema (DME)," Riad Sherif, MD, Chief Executive Officer of Oculis, said in a company news release. "Additionally, I am very pleased to welcome Ramin and Virginia to the executive team and to continue to work with Arshad, new Chair of the Oculis’ Retina SAB, as we continue to advance our clinical programs and start to prepare for our first potential launch in the US. I am certain that the extensive experience each of them brings will be invaluable to Oculis."
“We look forward to driving this positive momentum in clinical execution of both DIAMOND phase 3 trials, and in the delivery of clinical milestones this year, including topline results for the phase 2b RELIEF trial of OCS-02 in DED in Q2 2024," Dr. Sherif said.
Completion of Enrollment in Phase 2b RELIEF trial with Licaminlimab (OCS-02) in DED
The phase 2b RELIEF study evaluating topical anti-TNFα Licaminlimab (OCS-02) in DED was initiated in late 2023 and enrollment of 120 patients was completed.
“With its dual anti-inflammatory and anti-necrotic mechanisms of action, Licaminlimab eye drops have shown promising results in previous trials including: a significant reduction of ocular discomfort in DED, a rapid onset of action, and a good tolerability profile," said Elizabeth Yeu, MD, Eastern Virginia Medical School, Virginia Eye Consultants, and President of ASCRS. "Based on how the broader class of systemic TNFα inhibitors have dramatically improved the management of multiple inflammatory diseases in other therapeutic areas, I am eagerly awaiting the completion of the RELIEF trial to learn more about the potential of Licaminlimab eye drops to address the unmet needs of the millions of patients living with DED.”
Initiation of OCS-01 Phase 3 DIAMOND-2 Trial in DME
The first patient first visit was completed in the second 52-week phase 3 DIAMOND-2 trial evaluating OCS-01 eye drops for the treatment of DME, a leading cause of vision impairment in working-age adults. In Stage 1 of the DIAMOND program, OCS-01 demonstrated robust statistically significant improvement in vision and reduction in retinal edema vs. vehicle, and was well-tolerated with no unexpected safety findings. The visual acuity improvement observed with OCS-01 at 12-week was similar to approved injectables at the same time point. More information about the Stage 1 results can be found here.
Oculis Strengthens its Executive and Scientific Advisory Teams
Oculis also announced key executive appointments to bolster its leadership and scientific advisory teams. Retina specialists, Professor Ramin Tadayoni, MD, PhD, was appointed to the role of Chief Scientific Officer (CSO); and Arshad M. Khanani, MD, MA, FASRS, was appointed as Chair of Oculis’ Retina Scientific Advisory Board. In addition, Virginia R. Dean, a human resources executive with experience in growing life science companies, was appointed to the role of Chief Human Resources Officer.
Dr. Tadayoni, Dr. Khanani and Ms. Dean will play key strategic roles as the company continues to advance its late-stage pipeline and expands its footprint in the US while it prepares for the potential first commercial launch. Joanne Chang, MD, PhD, has decided to leave the organization for personal reasons and will continue to collaborate with Oculis on special projects.