- Topline results anticipated in Q4 2024 for Phase 2 trial evaluating the safety and tolerability of OCS-05 in patients with Acute Optic Neuritis (AON)
- Oculis also aims to complete an IND submission for OCS-05 in the
U.S. in 2024 - OCS-05 has been granted orphan drug designation in
the United States andEurope for AON, an indication for which there are no approved therapies
The Phase 2 ACUITY study is evaluating once-daily OCS-05 intravenous infusion in patients with AON. The study is ongoing across four (4) sites in
At present, there are no approved therapies for AON, leaving a significant gap in medical care for treatments that offer neuroprotection and can prevent vision loss. OCS-05 has been granted orphan drug designation in both
About OCS-05
OCS-05 is a serum-glucose corticoid kinase-2 (SGK-2) activator with the potential to become a neuroprotective therapy for acute optic neuritis and other neuro-ophthalmic diseases. In ophthalmology, this mechanism of action could potentially protect the nerve axons in conditions such as acute optic neuritis, to ultimately prevent vision loss. In animal models of neuroinflammation and neurodegeneration, OCS-05 has shown positive results in prevention of retinal ganglion cell damage and was associated with improvements in clinical function (disability). The Phase 2 ACUITY study in Acute Optic Neuritis (AON) is currently ongoing with results anticipated before the end of the year.
OCS-05 is an investigational drug and has not received regulatory approval for commercial use in any country.
About Phase 2 ACUITY Trial
The Phase 2 ACUITY is an ongoing randomized, double-blind, multi-center, two-arm, placebo-controlled study to evaluate the safety and tolerability of once daily OCS-05 intravenous infusion in patients with Acute Optic Neuritis (AON).
Positive outcomes in this trial could support the development of the compound for potential application in the treatment of ophthalmic conditions where neuroprotection is needed.
About Acute Optic Neuritis
AON is a rare disease characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 5 in 100,000 people worldwide each year and often represents the first sign of multiple sclerosis. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1). The acute inflammatory process of AON leads to the loss of myelin covering the optic nerve and the axons. At the onset, patients often suffer from ocular pain that increases with eye movement and vision loss. Once the inflammation recedes, remyelination often occurs but it is incomplete. Without the myelin sheath protecting the axon, neurons located in demyelinated segments become fragile and prone to death. Unfortunately, damaged axons cannot regrow, leading to permanent visual impairment.
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in
For more information, please visit: www.oculis.com
Oculis Contact:
Ms.
sylvia.cheung@oculis.com
Investor & Media Relations:
cdavis@lifesciadvisors.com
1-212-915-2577
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of OCS-05, including patient impact and market opportunity; the potential of OCS-05 to become a disease-modifying, neuroprotective therapy for AON, glaucoma and other neuro-ophthalmic diseases; the potential of OCS-05 to prevent vision loss; expected future milestones and catalysts; anticipated clinical readouts, including the anticipated topline results for the Phase 2 ACUITY study in AON; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; and the timing or likelihood of Oculis’ IND submission for OCS-05 in the
Source:
2024 GlobeNewswire, Inc., source