First patient visit complete in phase 3 trial of OCS-01 for diabetic macular edema
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Oculis has announced the first patient first visit in the second stage of its phase 3 DIAMOND-1 trial evaluating OCS-01, the company’s high-concentration formulation of dexamethasone for treatment of diabetic macular edema.
“OCS-01 is a promising clinical candidate that has already demonstrated its potential to treat both front and back of the eye indications with the positive results from stage 1 of the DIAMOND trial in DME and the phase 3 OPTIMIZE trial in inflammation and pain following cataract surgery,” Riad Sherif, MD, Oculis’ CEO, said in a company press release. “If approved, OCS-01 could become the first eye drop for DME and potentially transform the current treatment paradigm.”
According to the release, OCS-1 uses Oculis’ proprietary Optireach technology, which enables the formulation to reach the retina via topical administration, rather than ocular implantation or intravitreal injection.
“The treatment of DME with repeated intravitreal injections results in a significant burden for our patients,” Arshad M. Khanani, MD, MA, FASRS, director of clinical research at Sierra Eye Associates and co-principal investigator for the DIAMOND trial, said in the release. “As a field, we have been actively seeking noninvasive alternatives to address DME, aiming to intervene earlier and alleviate treatment burden.”
DIAMOND-1 is a two-stage, double-masked, randomized, multicenter trial assessing the safety and efficacy of OCS-01. Stage 1 focused on discerning the optimal dosing regimen, with OCS-1 demonstrating significant improvement in best corrected visual acuity compared with vehicle at week 6 after induction, the company stated. Sustained effects were reported through week 12 on maintenance dose.
The second stage will enroll 350 to 400 participants, who will be randomized 1:1 to receive OCS-01 or vehicle six times daily for 6 weeks during induction, then three times daily for a 46-week maintenance phase. The same endpoints will be evaluated in this stage, the company stated.
“The initiation of stage 2 of the DIAMOND-1 study marks a crucial advancement in the development of OCS-01, positioning it as a promising noninvasive treatment option for patients with DME,” Khanani said in the release.
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