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Oculis recently published positive data on the phase 2 clinical trial DX-211 of its development of topical therapeutic eye drops

Image credit: 123RF

The published Phase 2 clinical trial is a randomized, double-blind, multicenter, excipient-controlled study evaluating the safety and efficacy of OCS-01 in DME
patients.

The data showed that OCS-01 was more effective
than excipients in reducing central macular thickness (CMT) and improving vision in DME patients.

Patients treated with OCS-01 had an improvement in optimal corrected vision (BCVA) of 1.
58 ETDRS acuity chart letters (pre-specified significance level of 0.
15)
compared to baseline.

The mean CMT of OCS-01 at the time point after including all baselines in week 12 was statistically significantly reduced compared to the control group—by 54 μm in the OCS-01 group and 17 μm
in the control group at week 12.

When treatment was discontinued at week 12, CMT began to reverse to baseline thickness again, which demonstrated the pharmacological effect
of OCS-01 on retinal edema.

Subgroup analysis showed that patients with poorer visual acuity at baseline experienced greater
improvement.

In terms of safety, OCS-01 was well tolerated, and no significant or unexpected ocular adverse events
were observed.
Dr.
Riad Sherif, CEO of Oculis, said: "We are delighted with these data from phase 2 clinical study DX-211, which further enhances the potential
of OCS-01 as the first non-invasive eye drop to provide patients with a transformative treatment for DME.

Effective topical therapy with DME can expand the proportion of patients receiving treatment, especially those with newly developed DME
.

OCS-01 can also provide treatment options for patients who are treated by a general ophthalmologist prior to referral to a retinal specialist, increasing the chances
of such patients receiving treatment.

Oculis is committed to providing globally accessible life-changing treatments for the world's most common eye diseases, and we look forward to the results
of the ongoing Phase 3 DIAMOND trial.
"
"

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