Phase 2 data finds OCS-01 improves macular thickness, VA in DME patients

New research assessing the safety and efficacy of topical OCS-01 for the treatment diabetic macular edema (DME) shows promising results.

Oculis S.A. announced this week that the Phase 2 DX-211, a randomized, double blinded, multi-center and vehicle controlled clinical trial assessing the safety and efficacy of topical OCS-01 in patients with DME (NCT05343156) has been published in Acta Ophthalmologica.

A new subgroup analysis of the study was also presented Friday at the 22nd EURETINA Congress in Hamburg, Germany.

OCS-01 is a novel, high concentration, preservative free, topical formulation of dexamethasone that has the potential to be the first topical eye drop and non-invasive treatment for DME.

The reported data found OCS-01 to be superior to vehicle in the primary efficacy analysis of best-corrected vision acuity (BCVA) change from baseline with a between group difference of +1.58 ETDRS letters at the pre-specified significance level of 0.15.

These results further reinforce the potential of OCS-01 to provide patients with a potentially transformative treatment of DME as the first non-invasive, eye drop, option, according to Oculis CEO Riad Sherif, MD.

“An effective topical treatment for DME could expand the proportion of patients treated, especially those with recent onset DME, as well as provide a treatment option to general ophthalmologists prior to referral to a retina specialist and thereby, improving access to treatment,”Sherif stated, in a company news release.

Per the release, mean CMT showed a statistically significant greater decrease from baseline in the OCS-01 group compared to vehicle at all post-baseline time points up to and including Week 12 (-54µm OCS-01 vs. -17µm vehicle) and reversed towards baseline when treatment stopped at 12 weeks, demonstrating the pharmacological effect of OCS-01 on retinal edema.

OCS-01 was well tolerated and no significant or unanticipated ocular adverse events were observed.

Subgroup analysis in patients with BCVA baseline ≤ 65 letters, presented at EURETINA 2022, showed greater improvements in both CMT (-77.4µm OCS-01 vs. -23.1µm vehicle) and BCVA (+2.9 ETDRS letters in OCS-01 vs vehicle) at week 12.

OCS-01 is currently under investigation for the treatment of DME in the ongoing phase 3 DIAMOND trial to confirm these findings in a larger patient population.