2023 Will Be Pivotal Year for Oculis’ Potentially Transformative Medicines

Eye pic_Oculis

Photo Courtesy of Oculis

Ophthalmology is approaching a Renaissance as novel therapies are being developed to meet a variety of unmet needs that, with current therapies, may progress to blindness.

Oculis S.A. entered this space a few years ago, determined to identify those gaps. Rather than begin with a solution in search of a problem, it started with a thorough review of the therapeutic and market landscapes. That helped the Switzerland-based company identify pressing unmet therapeutic needs and innovative, differentiated approaches to meet those needs. For example, in an environment populated by injectable treatments that address part of the condition, Oculis is developing topical therapeutics that go a step further. Its current pipeline includes a topical therapeutic for diabetic macular edema, a topical biologic for dry eye disease and a potentially neuroprotective treatment for glaucoma, among other conditions.

OCS-01, Oculis’ lead asset, addresses diabetic macular edema, one complication of diabetes. It recently dosed the first patient in a Phase III trial.

As Riad Sherif, M.D., CEO of Oculis explained, the approved treatment (typically vascular endothelial growth factor – VEGF – inhibitors) is invasive. It requires regular injections into the eye, so it is given during the late stages of the disease. Unfortunately, only about half of the patients respond well.

“OCS-01,” in contrast, “is non-invasive, so it can address patients who otherwise wouldn’t be treated yet, and can also treat patients who are not responding to today’s standard of care,” Sherif told BioSpace.

“Of the millions of patients with diabetes, about 7% of them will develop diabetic macular edema. That’s roughly 30 or 35 million people now, and 45 or 50 million  by 2040, who will have serious vision issues,” Sherif said

Treatments for glaucoma – intraocular pressure, “which is like hypertension in the eye,” he explained – also have opportunities for improvement. Glaucoma causes a loss of periphery vision and, eventually, tunnel vision and blindness. Today, glaucoma is treated with beta blockers to reduce intraocular pressure. “The issue is that even when this pressure is treated effectively, between 10% and 20% of patients will become blind,” Sherif said. With 80 million people in the world suffering from glaucoma, this means at least 8 million will become blind.

The approved treatments don’t address the compression damage to the optic nerve that is caused by the intraocular pressure. OCS-05 addresses both issues. “We are extremely excited about it,” Sherif shared. “OCS-05 has very strong preclinical data showing efficacy in terms of protecting the neurons in the retina.”

OCS-05 is being studied in a France-based clinical trial for acute optic  neuritis right now. “It has the same physiological pathway as glaucoma. Data from this trial is expected at the end of 2023, and will serve as proof of concept (to support its development as a glaucoma therapy),” Sherif said.

Another compound, OCS-02, is a TNF-α antibody eye drop in Phase II trials for dry eye disease and anterior uveitis. “Only 14% of patients with dry eye renew their treatment, indicating the market is dissatisfied with current options,” Sherif said. That sentiment allows room for Oculis to develop a topical therapy that patients may be more likely to use.

“Whether a therapy is topical or injectable is just a means of delivery. What is most important is having the right formulation to appropriately address an issue,” Sherif said. “We have expertise in formulation discovery, so if a therapy is topical that’s great, but if another route of administration is better, we will do that. What drives us is doing what is best for the patient.

“Overall, I believe these drugs will have a transformative effect on ophthalmic care. For example, OCS-01, if approved, will be the first non-invasive eyedrop for retinal disease.

“Think about diabetic macular edema patients. They are (usually) in the 50s and 60s, so they are still working. In the U.S., they spend 29.5 days each year in consultations with healthcare providers. If you add in 12 days of injections, that comes to 42 working days just to take care of themselves.” With such a treatment burden, many don’t have the injections. Being able to administer eye drops to preserve their retinas themselves and only visit to a physician every three months would be transformative.  

OCS-05 can enable the same ease of treatment for glaucoma patients, allowing them to reduce the risk of (or perhaps avoid) becoming blind.

The next inflection points for Oculis are expected in 2023. The first will likely be a readout of the diabetic macular edema trial for OCS-01 during the first half of the year, with results from a Phase III trial for post-ocular surgery treatment and a Phase II trial in cystoid macular edema also expected. The readout for OCS-05 also is due near the end of 2023. Added to that, Sherif also expects results from a Phase II trial involving OCS-02 for dry eye that fall, with data from one additional Phase II trial in uveitis expected in 2024.

Next year, therefore, will be a pivotal year for Oculis and, perhaps, for ophthalmic therapies as well.

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