“The firm's mission is to provide treatments that can potentially change the lives of patients with different eye diseases.”

Oculis is a biopharmaceutical firm committed to improving eye care by innovative treatments for eye diseases. The roots of the company are in the creation of the OPTIREACH® solubilizing formulation technology by Professors Einar Stefánsson and Thorsteinn Loftsson, which allows eye drops to successfully reach the back of the eye. This achievement pushed Oculis to create a wide range of product candidates designed to meet unmet needs in ophthalmology. The firm's mission is to provide treatments that can potentially change the lives of patients with different eye diseases. Oculis continues to progress research and clinical development to enhance the vision and quality of life for people across the globe.

Oculis’ Areas of Focus

Diabetic Macular Edema|OCS-01

Oculis is committed to the development of new, non-surgical treatments for diabetic macular edema (DME), a major cause of blindness in working-age adults. DME is a chronic complication of diabetic retinopathy, resulting from uncontrolled blood sugar levels that destroy retinal blood vessels and cause inflammation and fluid accumulation in the macula, the part of the eye that deals with detailed central vision. It has a serious impact on everyday activities like reading, the ability to recognize faces, and driving.

Existing treatments for DME are invasive, involving repeated injections or implants into the eye, which are a heavy burden to the patients, particularly those with mild visual impairment or newly diagnosed ones. Moreover, approximately 40% of patients respond inadequately to anti-VEGF therapies, the current standard of care. Clearly, there is an urgent need for different treatment choices.

Oculis is filling this need with OCS-01, an investigational dexamethasone eye drop with a high concentration developed using the proprietary OPTIREACH® technology. This new format allows the drug to access the posterior segment of the eye through topical administration, providing a non-invasive treatment option to the standard of care. In initial trials, OCS-01 showed substantial increases in visual acuity and macular edema reduction, holding out promising potential both for earlier intervention and for patients that are not as responsive to current therapies. With approval, OCS-01 has the potential to transform DME treatment by offering an easier and more effective solution for patients globally.

Post ocular surgery| OCS-01     

Oculis is developing to meet the unmet medical requirements in the treatment of post-ocular surgery inflammation and pain, specifically cataract surgery—the most prevalent surgeries globally. Every year, there are about 20 million cataract surgeries performed worldwide, and that number is poised to increase exponentially because of aging populations. Inflammation post-surgery, if not treated, may result in complications like cystoid macular edema (CME), a frequent etiology of loss of vision after cataract surgery, especially in diabetic, uveitic, or retinal vascular disease patients.

Patients today have to follow complex schedules of multiple eye drops taken several times daily, such as steroids, NSAIDs, and antibiotics. High treatment burden, however, results in poor compliance, risking complications. To solve this, Oculis is working on OCS-01, a once-daily, preservative-free, high-concentration dexamethasone eye drop, based on the proprietary OPTIREACH® formulation technology. This technology improves drug solubility and extends ocular surface residence time, allowing less frequent dosing and better drug delivery.

In the Phase 3 OPTIMIZE-1 clinical trial, OCS-01 achieved both primary endpoints, showing efficacy in inflammation and pain reduction following cataract surgery, and was well tolerated with a positive safety profile. Approved, OCS-01 would be a significant innovation by streamlining treatment and enhancing patient compliance in post-ocular surgery treatment.

Acute optic neuritis| OCS-05

Oculis is committed to developing innovative treatments for neuro-ophthalmic diseases, specifically acute optic neuritis—a severe but uncommon condition that frequently causes permanent visual impairment. Acute optic neuritis predominantly occurs in young adults and is accompanied by inflammation of the optic nerve, giving rise to symptoms such as pain in the eye, loss of vision, and worsening of color vision. While corticosteroids are routinely used to treat the acute phase, there is a large unmet need for treatments that can prevent vision loss and offer neuroprotection once the inflammation resolves. OCS-05, a new peptidomimetic small molecule, is in clinical development as a first-in-class neuroprotective treatment for acute optic neuritis and other neuro-ophthalmic disorders. It acts by stimulating trophic factor pathways like IGF-1 and BDNF, which are important for the protection of nerves. In preclinical models, OCS-05 has exhibited promising outcomes in stopping retinal ganglion cell damage and restoring clinical function in models of neuroinflammation and neurodegeneration.

The ACUITY trial, which tested OCS-05 in patients with acute optic neuritis, had positive outcomes. The drug achieved its primary safety endpoint and had statistical significance in secondary endpoints involving visual function as well as structural neuroprotection. OCS-05, if approved, may provide a new method of maintaining vision in those patients with optic neuritis as well as other diseases such as neuro-ophthalmic disease.

Riad Sherif, M.D. - CEO

“Oculis drives innovation from a patient perspective, focusing on eye diseases where significant unmet medical needs remain. As the company rethinks ophthalmology, it undertakes a disciplined and rigorous process to understand the biology behind eye diseases.”