Diabetic Macular Edema (DME)
OCS-01, an OPTIREACH® formulation of high concentration dexamethasone eye drop, has the potential to become the first non-invasive treatment option for DME
DME is a leading cause of preventable blindness in working-age adults
DME is a progressive complication of diabetic retinopathy and is related to having consistently high blood sugar levels that damage nerves and blood vessels in the macula. It affects the area of the retina responsible for sharp vision used in activities of daily living such as reading, recognizing faces, and driving.
DME occurs when blood vessels in the retina swell and then leak, leading to a fluid build-up (edema) in the retina. This swelling and leakage are often exacerbated by inflammatory processes within the eye. There remains a significant need for early intervention and patients inadequately controlled with the current standard of care.
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DME 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 20401,2.
Current treatment options for DME are invasive, intravitreal injections (needle into the eye) or ocular implants
OCS-01
is an innovative eye drop candidate to treat DME. It was developed with the proprietary OPTIREACH® technology to enable drug passage from the anterior segment of the eye to the retina following topical application, a route of administration that contrasts with currently available DME therapies, all requiring invasive delivery to reach the retina such as ocular implants or intravitreal injections.
OCS-01 eye drops successfully completed Stage 1 of the DIAMOND Phase 3 program in DME with 148 patients randomized. In this trial, results show a significant increase in visual acuity, a higher percentage of patients achieving ≥15-letter improvement in BCVA and a reduction of macular edema, all with statistical significance, consistent with the positive results observed in the previous Phase 2 trial. Stage 2 of the DIAMOND Phase 3 clinical program commenced in December 2023 and both 52-week Phase 3 trials completed enrollment in April 2025.
If approved, OCS-01 would become the first non-invasive therapy for DME with the potential to address unmet medical needs for both earlier treatment intervention and patients inadequately controlled with the current standard of care.
OCS-01 is an investigational drug and its safety or efficacy has not been established and it has not received regulatory approval for commercial use in any country.
OCS-01 eye drops successfully completed Stage 1 of the DIAMOND Phase 3 program in DME with 148 patients randomized. In this trial, results show a significant increase in visual acuity, a higher percentage of patients achieving ≥15-letter improvement in BCVA and a reduction of macular edema, all with statistical significance, consistent with the positive results observed in the previous Phase 2 trial. Stage 2 of the DIAMOND Phase 3 clinical program commenced in December 2023 and both 52-week Phase 3 trials completed enrollment in April 2025.
If approved, OCS-01 would become the first non-invasive therapy for DME with the potential to address unmet medical needs for both earlier treatment intervention and patients inadequately controlled with the current standard of care.
OCS-01 is an investigational drug and its safety or efficacy has not been established and it has not received regulatory approval for commercial use in any country.
OCS-01 eye drops: Perspectives from global retina experts
Explore OCS-01 Clinical Trials in DME
Phase 3: Clinical Trial Evaluating The Efficacy and Safety of OCS-01 in DME (DIAMOND-1)
Phase 3: Clinical Trial Evaluating The Efficacy and Safety of OCS-01 in DME (DIAMOND-2)
Phase 2: Efficacy and Safety of Dexamethasone Nanoparticles (OCS-01) Eye Drops in Diabetic Macular Edema
Visionary Innovation to Deliver Breakthrough Therapies
The treatment of DME with repeated intravitreal injections results in a significant burden for our patients. Within our field of retina, we have been vigorously seeking non-invasive alternatives, aiming to intervene earlier and alleviate treatment burden. The very encouraging results from the Phase 3 DIAMOND Stage 1 program show that OCS-01 is a promising non-invasive treatment candidate which could address these unmet needs.