Swiss biopharmaceutical company Oculis has announced positive phase II results for its novel dexamethasone topical eye drop for reducing swelling and improving vision in diabetic macular oedema (DMO) patients.
Oculis’ OCS-01 is delivered using the company’s patented, soluble nanoparticles technology, which increases the drug’s concentration without affecting lipophilicity, said the company. “It is designed to improve the contact time on the eye surface through interaction with the mucous layer and to enhance the lipophilic drug delivery, through high and prolonged concentrations in the tear film to help it permeate the lipid membrane.”
“The current standard of care involves intravitreal injections and this has a marked negative impact on patient compliance, accessibility and treatment sustainability,” said Oculis’ scientific advisory board chairman, Professor Pravin Dugel, from the Keck School of Medicine at the University of Southern California. “OCS-01, as a topical drug presents a truly innovative, non-invasive approach that has the potential to change the treatment paradigm in DMO, and one that would be welcomed by physicians and patients alike.”
The prospective, multi-centre, randomised, double-masked, parallel group and vehicle-controlled study included type 1 or 2 diabetic patients with DMO and central macular thickness (CMT) of ≥ 310µm by SD-OCT and ETDRS best corrected visual acuity (BCVA) letter score ≤ 73 and ≥ 24. Treatment was randomised with OCS-01 or matching vehicle eye drops, one drop three times per day for 12 weeks. Efficacy was evaluated based on the change from baseline to week 12 of CMT and ETDRS BCVA letter score. Safety was assessed in terms of adverse events and ophthalmology examination.
A total of 144 patients were included and 133 completed the study. Researchers found the mean CMT showed a greater decrease from baseline in the OCS-01 group compared to the vehicle arm at week 12 (-53.6μm vs -16.8μm, p=0.0115). Mean change in ETDRS BCVA letter score from baseline to week 12 was higher in the OCS-01 group than the vehicle group (+2.62 letters vs +1.04 letters, p= 0.125). Researchers found ocular tolerability was similar between groups except for a change in intraocular pressure (IOP). IOP increases were more common with OCS-01 than vehicle during the treatment period, consistent with known dexamethasone effects, they said.
