LONDON – Oculis SA has delivered positive phase IIb data for OCS-01, a topical nanoparticle formulation of dexamethasone, in the treatment of the after-effects of cataract surgery, meeting the primary endpoints of reducing both inflammation and pain.

The percentage of eyes with zero inflammation was 51% in patients dosed once a day with OCS-01 vs. 19.6% for vehicle at day 15 (p=0.0009). Meanwhile, the percentage of eyes with zero pain at day four was 72.5% vs. 54.9% for vehicle (p=0.005). The results were presented on Saturday, May 16, at the online American Society of Cataract and Refractive Surgery annual meeting by Eric Donnenfeld, clinical professor of ophthalmology at New York University.

Following cataract surgery, patients often have to self-administer eye drops several times a day to manage discomfort, Donnenfeld said. “OCS-01 administered once daily shows clear superiority in reducing inflammation and pain when compared to vehicle,” he said.

“The ideal situation was dosing one time a day, and that’s where we are,” said Riad Sherif, CEO of Oculis. “This is a very good result compared to the literature. It’s the first such good solid result and the first ever once-daily dosing,” he told BioWorld.

Cataract surgery is the most common procedure in the world. Many patients experience pain and almost all experience inflammation, despite the use of minimally invasive techniques. The procedure results in inflammation in the cornea, anterior chamber and iris. Microscopic remnants of the cataract may be left in the anterior chamber, further promoting inflammation.

Riad Sherif, CEO, Oculis

The phase IIb results leave Lausanne, Switzerland-based Oculis sitting on two indications for OCS-01, having reported positive results in the treatment of diabetic macular edema in February this year. In the phase II proof-of-concept trial, the eye drops reduced central macular thickness, leading to an improvement in best corrected visual acuity in the 144-patient randomized study.

Oculis’ nanoparticle technology is designed to increase solubility of dexamethasone in tear fluid, increasing residence time of the active drug. The drops also are able to penetrate the mucous layer, providing sustained drug release.

Taken together, the two trials reinforce the potential of OCS-01 to provide a topical formulation that is administered less frequently for front-of-eye conditions, and to offer a topical alternative for a retinal disease that currently is treated with injections or implants, said Sherif.

“This second trial really validates what we’ve always thought about the technology, that it can treat retinal conditions with eye drops and can reduce the number of administrations for the front of the eye,” he said.

Oculis has an end-of-phase II meeting with FDA at the end of May to discuss the data. The hope is to take both indications forward into phase III at the same time.

Laying the ground for phase III development, last month Oculis appointed Frederic Pilotaz, a specialist in ophthalmic drug formulation, as vice president of technology and pharmaceutical science, to take forward OCS-01 commercial manufacturing. Pilotaz joined the company from eye care specialist Nicox SA.

The company also has appointed Marcia de Souza Lima as chief medical officer to lead the phase III program. De Souza Lima joined from Takeda Pharmaceutical Ltd. subsidiary Shire plc, where she was head of medical affairs for ophthalmology.

Assuming FDA approval, Sherif said it is “realistic to think phase III can start at the beginning of next year.”

Cataract removal may be the most common procedure in the world, but currently much elective surgery is suspended because of the COVID-19 crisis. Sherif said he is hopeful the situation will have eased by the time the phase III is ready to enroll.

In the meantime, the next step is to raise money to fund the trial. “Our plan is to work on the next financial round in the second half of the year,” said Sherif.

How much Oculis will aim to raise hangs on the shape of the phase III program. “It depends on trial design, how many studies, if we can run in parallel, or in a phased approach,” Sherif said. “Once we have clarity from FDA we can sit down with investors and discuss what makes sense.”

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