Oculis Holding AG announced that Eric Donnenfeld, MD, presented the positive results from the phase 3 OPTIMIZE-1 trial of OCS-01 for the treatment of inflammation and pain following cataract surgery at the 2024 ASCRS annual meeting, which took place April 5-8, 2024, in Boston, MA.
Dr. Donnenfeld 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” on Sunday, April 7th. The results 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).
Eric Donnenfeld, MD, clinical professor of Ophthalmology at New York University and co-chair of the Oculis Scientific Advisory Board, said: “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. 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. 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, added: “We are excited that Dr. 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. 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.
For more information about ASCRS 2024 visit: https://annualmeeting.ascrs.org/.
About inflammation and pain following ocular surgery
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 2037.1,2
Cataract surgeries are the most prevalent procedures of all medical specialties with an estimated 5 million procedures in 2021 in the US.2 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 eye drops and the OPTIREACH technology
Leveraging Oculis’ proprietary OPTIREACH technology, OCS-01 is a novel, high concentration dexamethasone eye drop. 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.