Post Ocular Surgery

OCS-01, an OPTIREACH® formulation of high concentration dexamethasone eye drop, designed to be the first once-daily, preservative-free steroid for treating inflammation and pain following ocular surgery

Cataract surgeries are the most prevalent procedures of all medical specialties1

Most cataracts are related to aging and by age 80, more than half of all Americans either have a cataract or have had cataract surgery.

A cataract is a clouding of the lens in the eye that affects vision. The purpose of the lens is to bend (refract) light rays that come into the eye to help people see. A natural lens is clear, but as people age, it becomes cloudy. Having a cataract can be like looking through a foggy or dusty car windshield. Things may look blurry, hazy and less colorful.

During cataract surgery, the cloudy natural lens is removed and replaced with a clear artificial lens. That lens is called an intraocular lens (IOL).

PREVALENCE
~20M

cataract surgeries are performed every year globally (~60,000 every day)1. Post ocular surgery treatment regimen requires multiple daily doses of different eye drops to alleviate inflammation and pain, as well as prevent infections.

Ophthalmic surgeries are on the rise, mainly due to the aging population and lifestyle changes. They are expected to reach close to ~10 million procedures per year in the U.S. alone by 20372.

Patients need to take multiple daily doses of eye drops to alleviate inflammation and pain

Ophthalmic surgeries cause the release of inflammatory factors and can be associated with ocular pain. Cataract surgery, even with a very small incision, creates inflammation in the cornea, anterior chamber and iris. Controlling inflammation following ocular surgery helps prevent the risk of developing complications such as cystoid macular edema (CME), the most common cause of decreased vision in patients following cataract surgery. Cystoid macular edema is a condition that involves swelling in the macula, the center part of the retina that allows us to see objects with great details.
This swelling occurs as fluid builds up in the layers of the macula, gradually blurring vision. Diabetes patients are at higher risk of developing CME following cataract surgery as well as patients with uveitis or a history of retinal vascular disease which can represent up to one third of patients.

Ophthalmologists currently rely on topical steroids to treat ocular inflammation following ocular surgery as part of a regimen that includes steroids, antibiotics and NSAIDs, which can have different dosing regimens and require several drops daily, all leading to potential compliance issues. Oculis is developing OCS-01, potentially the first once-daily, high concentration, preservative-free steroid eye drop for treating inflammation and pain following ocular surgery to help address some of the remaining unmet medical needs.
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OCS-01

Leveraging Oculis’ proprietary OPTIREACH® technology, OCS-01 is a once-daily high concentration eye drop candidate.

The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling less frequent administration for front-of-the-eye and the drug passage from the eye surface to the posterior segment for back-of-the-eye diseases.

In the Phase 3 OPTIMIZE-1 clinical trial, OCS-01 eye drops met both primary endpoints with a once-daily dosing regimen for the treatment of inflammation and pain following cataract surgery.

Furthermore, OCS-01 was well tolerated with a favorable safety profile. The data is consistent with the Phase 2 SKYGGN trial for the same indication.

If approved, OCS-01 will be the first once-daily, high concentration, preservative-free steroid eye drop for treating inflammation and pain following ocular surgery.

OCS-01 eye drop is also being investigated in Phase 3 trials for diabetic macular edema (DME) and in an investigator initiated trial (IIT) for cystoid macular edema (CME).

OCS-01 is an investigational drug and has not received regulatory approval for commercial use in any country.

Explore OCS-01 Clinical Trials in Post Ocular Surgery

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COMPLETED

Phase 3: Results of OCS-01 Eye Drops for the Treatment of Inflammation and Pain following Cataract Surgery (OPTIMIZE-1)

VIEW RESULTS
COMPLETED

Phase 2: OCS-01 in Treating Inflammation and Pain in Post-Cataract Patients (SKYGGN)

CLINICALTRIALS.GOV

Rethinking Ophthalmology to Save Sight and Improve Eye Care

Once daily OCS-01 could become an attractive option to treat pain and inflammation after ocular surgery with a highly potent anti-inflammatory effect. This could be especially beneficial for high-risk patients, such as diabetic patients, who face an increased risk of complications following ocular surgery due to pre-existing underlying inflammation.”

Rethinking Ophthalmology