Oculis completed Phase 1 patient recruitment for Phase 3 clinical DIAMOND

Oculis S.
A.
("Oculis"), an international biopharmaceutical company dedicated to improving vision and protecting the eyes, announced on January 5 that it has completed Phase 1 patient enrollment in its Phase 3 clinical trial
.
The trial, called DIAMOND (DIAbetic Macular edema patients ON a Drop), was designed to evaluate the effectiveness and safety
of OCS-01 in patients with diabetic macular edema (DME).

Oculis initiated the Phase 3 clinical trial of DIAMOND in two phases in late 2021, a randomized, double-blind, placebo-controlled, multi-country, multicenter clinical trial
of OCS-01 for the treatment of DME 。 In two phases, the Best Corrected Visual Acuity Chart (BCVA ETDRS) of the Early Treatment of Diabetic Retinopathy Study was used to measure mean change from baseline to week 6 (phase 1) and week 52 (phase 2) as the primary endpoint; Several visual and anatomical indicators were used as secondary endpoints, including SD-OCT (spectral domain optical coherence tomography) to measure the mean change
in macular retinal thickness (CST, central retinal thickness) from baseline.

Utilizing Oculis' Optireach® proprietary technology, OCS-01 is a topical formulation of a new high-concentration dexamethasone eye drop, which has the potential to become the first eye drop to treat DME, initiating a non-invasive treatment
for DME.
Once approved, OCS-01 will pioneer eye drops for DME, allowing physicians to personalize treatment for patients to maximize DME outcomes
.

Riad Sherif, MD, CEO of Oculis, said: "I am delighted that Oculis has completed patient enrollment for Phase 1 of our DIAMOND study
.
This is a testament to our dedicated team, who are now focused on completing the study and preparing
for Phase 1 data interpretation, which is expected to be published in mid-2023.
This research is a key step in our efforts to develop new and more accessible therapies for DME that can help physicians improve their patients' vision and enhance their quality of life
.
" "

Professor David S.
Boyer, MD, Clinical Professor of Ophthalmology at the Keck School of Medicine of Southern California and principal investigator of the DIAMOND clinical trial, said: "The way topical drugs are treated will bring important advantages, including early intervention and treatment accessibility, convenience, and non-invasiveness
.
Currently, OCS-01, using its proprietary Extraction® technology, appears to be the most promising drug
candidate already in Phase 3 clinical trials.
If approved, it can be used for early stand-alone treatment of DME, or as an adjunct treatment
.
This effective topical treatment with eye drops will allow doctors to treat DME earlier, possibly by combining it with current standard treatment regimens, to improve efficacy or persistence
.
"

Arshad M.
Khanani, MD, director of clinical research at Sierra Eye Associates in Reno, Nevada, and principal investigator of the DIAMOND clinical trial, commented, "If successful, OCS-01 will be an important treatment option
for the treatment of patients with DME.
As the first topical eye drop and non-invasive treatment for DME, OCS-01 will benefit patients diagnosed with DME around the world, making treatment faster and easier to access
.
This will significantly reduce the burden on the healthcare system and improve patient outcomes
.
"

OCS-01 has been shown to improve visual acuity and reduce macular retinal thickness in DME patients compared to placebo, and has shown a favorable safety profile
in a Phase 2b (DX-211) trial in 144 patients.
Data from the Phase 2 clinical trial were first presented in February 2020 at the "Angiogenesis Exudation, and Degeneration 2020" conference and published in the journal Acta Ophthalmologica in June 2022
.