Nicox SA, an international ophthalmology company, recently announced a Phase 3 clinical trial for NCX 470 to lower intraocular eye pressure. The article recently appeared in Eye Wire News.
The trial, named Mont Blanc, will be evaluating NCX 470 in patients who have ocular hypertension or open-angle glaucoma. Over six hundred patients are expected to participate in several locations across the U.S., plus several sites in China. Nicox announced the enrollment of the first twelve patients this week.
Glaucoma is the result of optic nerve damage which leads to the loss of peripheral vision and eventually central vision loss. If not treated, glaucoma can result in irreversible blindness. It is considered to be one of the three primary causes of blindness in the world.
High intraocular pressure (IOP) caused by malfunction of the eye’s drainage system is perhaps most commonly associated with glaucoma.
Medications used currently are designed to lower a patient’s IOP. However, these medications vary in efficacy and leave the door open to treatments that are more effective.
About NCX 470
NCX 470 is Nicox’s nitric oxide prostaglandin analog (PG) that reduces elevated IOP and ocular hypertension by increasing the fluid outflow (aqueous humour). The PGs (e.g. latanoprost) are considered to be the gold standard in treating IOP.
About the Mont Blanc Phase 3
The Phase 3 Mont Blanc clinical trial will evaluate the NCX 470 ophthalmic solution for safety and efficacy. The drug will be compared to the ophthalmic solution, latanoprost, the current standard of care, and the leader in prescriptions for prostaglandin analogs.
Patients with ocular hypertension or open-angle glaucoma will participate in the double-masked three-month trial. Neither the investigators nor the patients are aware of which drugs are being administered.
At some point in the trial, a specific dose of NCX 470 will be chosen. The dosing will continue at that level for the balance of the trial.
About the Dolomites Phase 2 Trial
Results from the previous trial, Dolomites, have proven that NCX 470 is superior to latanoprost in lowering IOP according to a Nicox spokesperson. NCX 470 showed noninferiority to latanoprost as well as superiority.
Noninferiority is demonstrated in some trials to establish that a subject of the trial is not substantially worse than the control therapy.
Nicox acknowledges that there may be potential delays in clinical timelines due to COVID-19. It will issue timely statements should a delay occur.