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Oculis releases positive results from Phase 3 OPTIMIZE-1 trial of OCS-01 for treatment of inflammation, pain after cataract surgery


OCS-01 positive results in the first Phase 3 OPTIMIZE-1 trial were presented at the American Society of Cataract and Refractive Surgery, while topline readout from the second Phase 3 OPTIMIZE-2 is anticipated later this year to support an NDA submission.

(Image Credit: AdobeStock/New Africa)

(Image Credit: AdobeStock/New Africa)

Oculis Holding AG announced positive results from the Phase 3 OPTIMIZE-1 trial of OCS-01 for the treatment of inflammation and pain following cataract surgery were presented at the 2024 ASCRS Annual Meeting, April 5 to 8, 2024, in Boston.

At the meeting Eric Donnenfeld, MD, presented the “Once Daily OCS-01, an OPTIREACH Formulation of High Concentration Dexamethasone Eye Drop, for Inflammation and Pain Following Cataract Surgery – a Phase 3, Double-Masked, Vehicle-Controlled Study.”

According to a news release, results of the trial showed that 57.2% of patients treated with OCS-01 were inflammation free (i.e. absence of anterior chamber cells) at Day 15 (vs. 24.0% with vehicle, p < 0.0001), and 75.5% had absence of ocular pain at Day 4 (vs. 52.0% with vehicle, p < 0.0001).1

Donnenfeld, who is clinical professor of Ophthalmology at New York University and co-chairman of the Oculis Scientific Advisory Board, pointed out the results from OPTIMIZE-1 were highly compelling, showing statistically significant impact on treating inflammation and pain following cataract surgery.

“Current treatment regimens require multiple daily doses of different eye drops, and having an effective once daily highly potent and safe anti-inflammatory eye drop with a good tolerability profile would meaningfully reduce the burden for patients, caregivers, and ultimately, improve surgery outcomes,” he said. “OCS-01 is truly a unique product candidate with two specific advantages over conventional eye drops: a highly concentrated formulation with 15 times the concentration of available and approved dexamethasone eye drops and an improved solubility profile to enhance eye tissue penetration.”

Donnenfeld noted in the news release these specific characteristics could explain the impressive results in DME in which OCS-01 eye drops significantly improved visual acuity and reduced macular edema.

Riad Sherif, MD, CEO of Oculis, said the company was pleased that Donnenfeld shared the results from the OPTIMIZE-1 Phase 3 trial of OCS-01 at the ASCRS conference.

“The development program of OCS-01, a novel eye drop in development for both front-and-back-of-the-eye diseases, is progressing as planned with three ongoing Phase 3 trials: the second Phase 3 OPTIMIZE-2 trial, and the two ongoing 52-week DIAMOND-1 and DIAMOND-2 Phase 3 trials in DME.,” Sherif said in the news release. “We look forward to sharing further milestone achievements of our pipeline including the upcoming topline clinical readouts with our differentiated assets as the year progresses.”

Oculis initiated the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop in late 2023 and topline readout is expected before the end of 2024. The two Phase 3 OPTIMIZE trials are expected to support an NDA submission.

Ophthalmic surgeries are on the rise, mainly due to the aging population and lifestyle changes, and are expected to reach close to 10 million procedures per year in the U.S. alone by 20372,3. Cataract surgeries are the most prevalent procedures of all medical specialties with an estimated 5 million procedures in 2021 in the US.3

According to the news release, 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. Ophthalmologists currently rely on topical steroids to treat ocular inflammation and the full regimen following ocular surgery often includes steroids, antibiotics and NSAID, which can have a different dosing regimen and require several drops daily for a post-op patient to administer, all leading to potential compliance issues.

About OCS-01

Leveraging Oculis’ proprietary OPTIREACH technology, OCS-01 is a novel, high concentration dexamethasone eye drop.

The company noted in its news release the OPTIREACHsolubilizing 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.

1. AG OH. Positive Results from Phase 3 OPTIMIZE-1 Trial of Once Daily OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery Presented at the 2024 American Society of Cataract and Refractive Surgery Annual Meeting. GlobeNewswire News Room. Published April 8, 2024. Accessed April 8, 2024. https://www.globenewswire.com/news-release/2024/04/08/2859008/0/en/Positive-Results-from-Phase-3-OPTIMIZE-1-Trial-of-Once-Daily-OCS-01-for-the-Treatment-of-Inflammation-and-Pain-Following-Cataract-Surgery-Presented-at-the-2024-American-Society-of-.html
‌2. 2016 HCUP procedure volume and growth rate, and corroborated by Rochester Epidemiology Project Paper. Third party market research.
3. Meddevicetracker – Ophthalmic Surgical Products Market 2017.
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