Acute Optic Neuritis
OCS-05, a novel first-in-class peptidomimetic small molecule, has the potential to become a neuroprotective therapy for acute optic neuritis and other neuro-ophthalmic diseases
Acute optic neuritis is an acute inflammation of the optic nerve that can lead to permanent visual impairment most commonly in young adults
The acute inflammatory process of acute optic neuritis 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. Acute optic neuritis is associated with deteriorating visual acuity and color vision as well as the presence of flashing lights.
The loss of vision ranges considerably between patients from mild blurring to loss of perception of light. The condition tends to worsen over the first several days before starting to improve over the following two weeks. The recovery can take as long as a year after onset.
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.
Acute optic neuritis is a rare condition affecting up to 8 in 100,000 people worldwide1 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).
Unmet needs remain for therapies that can prevent vision loss after an acute episode of optic neuritis
OCS-05
a first-in-class peptidomimetic small molecule with the potential to be a novel neuroprotective therapy for acute optic neuritis and other neuro-ophthalmic diseases.
Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this mechanism of action could potentially protect the nerve axons in conditions such as acute optic neuritis, and other neuro-ophthalmic diseases, to ultimately prevent vision loss.
OCS-05 has shown positive results in the prevention of retinal ganglion cell damage and was associated with improvements in clinical function (disability) in animal models of neuroinflammation and neurodegeneration.
The ACUITY (Acute OptiC NeUrITis of DemYelinating Origin) trial is randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate a once-daily intravenous infusion of OCS-05 over five days, compared with placebo, in patients with acute optic neuritis receiving steroids. In addition to safety, other secondary efficacy endpoints are being measured to evaluate the potential neuroprotection treatment effect and vision improvement in acute optic neuritis patients.
Positive outcomes in this trial could support also the development of the compound for potential treatment of other neuro-ophthalmic conditions including glaucoma, diabetic retinopathy and neurotrophic keratitis.
OCS-05 is an investigational drug and has not received regulatory approval for commercial use in any country.
Its mechanism of action is related to the activation of the trophic factor pathways such as IGF-1 and BDNF. In ophthalmology, this mechanism of action could potentially protect the nerve axons in conditions such as acute optic neuritis, and other neuro-ophthalmic diseases, to ultimately prevent vision loss.
OCS-05 has shown positive results in the prevention of retinal ganglion cell damage and was associated with improvements in clinical function (disability) in animal models of neuroinflammation and neurodegeneration.
The ACUITY (Acute OptiC NeUrITis of DemYelinating Origin) trial is randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate a once-daily intravenous infusion of OCS-05 over five days, compared with placebo, in patients with acute optic neuritis receiving steroids. In addition to safety, other secondary efficacy endpoints are being measured to evaluate the potential neuroprotection treatment effect and vision improvement in acute optic neuritis patients.
Positive outcomes in this trial could support also the development of the compound for potential treatment of other neuro-ophthalmic conditions including glaucoma, diabetic retinopathy and neurotrophic keratitis.
OCS-05 is an investigational drug and has not received regulatory approval for commercial use in any country.
OCS-05 ACUITY Trial
Phase 2: OCS-05 in Patients With Acute Optic Neuritis (ACUITY)
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Acute optic neuritis is a rare disease characterized by acute inflammation and demyelination of the optic nerve. While corticosteroids are used to shorten the attack, there is no specific treatment approved for acute optic neuritis and unmet needs remain for neuroprotective therapies that can prevent vision loss.”