NCX 470 for Glaucoma

(Whistler Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Nicox Ophthalmics, Inc.

Disqualifiers: Narrow angles, Ocular disease, Uncontrolled disease, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial uses an eye drop solution called NCX 470, a nitric oxide (NO)-donating bimatoprost, to study its effects on eye fluid movement in healthy individuals and those with high eye pressure.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug NCX 470 for glaucoma?

Research shows that NCX 470, a combination of bimatoprost and nitric oxide, is more effective at lowering eye pressure than bimatoprost alone in animal models of ocular hypertension and glaucoma. This suggests it could be a promising treatment for reducing eye pressure in glaucoma patients. ^{1 2 3 4 5}

Is NCX 470 safe for human use?

NCX 470, a nitric oxide-donating version of bimatoprost, has been studied in animal models and shown to lower eye pressure effectively. While specific human safety data is not detailed in the provided research, bimatoprost, a component of NCX 470, is already used in humans for eye conditions, suggesting a potential safety profile. However, more specific human safety studies would be needed to confirm this. ^{2 3 4 5 6}

How does the drug NCX 470 for glaucoma differ from other treatments?

NCX 470 is unique because it combines bimatoprost, a common glaucoma medication, with nitric oxide, which helps relax eye tissues to improve fluid drainage and lower eye pressure more effectively than bimatoprost alone. ^{2 3 4 6 7}

Research Team

Eligibility Criteria

This trial is for adults over 18 years old, of any gender, who do not have glaucoma but may have ocular hypertension (OHT) with eye pressure between 16 and 28 mmHg. It's not suitable for people already diagnosed with glaucoma.

Inclusion Criteria

I do not have glaucoma.

Your eye pressure is between 16 and 28 mmHg.

My gender does not exclude me from this trial.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive NCX 470 0.1% or placebo, one drop in the randomized eye once a day for 8 days

8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• NCX 470 (Prostaglandin Analog)

Trial Overview The study tests NCX 470 ophthalmic solution against a placebo to see how it affects the fluid dynamics in the eyes of healthy volunteers or those with high eye pressure but no glaucoma.

Participant Groups

Group I: NCX 470 0.1% Active Control 1 Intervention

NCX 470 0.1% - one drop in the randomized eye once a day for 8 days

Group II: Placebo Placebo Group 1 Intervention

Artificial tears - one drop in the randomized eye once a day for 8 days

Who Is Running the Clinical Trial?

Nicox Ophthalmics, Inc.

Lead Sponsor

Trials

7

Recruited

2,800+

Findings from Research

Prostaglandin analogs like bimatoprost, latanoprost, and travoprost are effective and well-tolerated treatments for reducing intraocular pressure in patients with open-angle glaucoma and ocular hypertension, offering an alternative for those who do not respond to standard treatments.

These medications are at least as effective as the commonly used beta-blocker timolol, and while they can be combined with other treatments, more research is needed to determine the best combinations and to assess any differences in efficacy among the prostaglandin analogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostaglandin analog treatment of glaucoma and ocular hypertension. Alexander, CL., Miller, SJ., Abel, SR.[2018]

NCX 470, a new compound combining bimatoprost with nitric oxide, significantly lowers intraocular pressure (IOP) more effectively than bimatoprost alone in three animal models, including rabbits, monkeys, and dogs.

The enhanced IOP-lowering effect of NCX 470 is attributed to its dual action on the PGF2α and NO/cGMP signaling pathways, demonstrating its potential as a superior treatment for glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular Pressure-Lowering Activity of NCX 470, a Novel Nitric Oxide-Donating Bimatoprost in Preclinical Models. Impagnatiello, F., Toris, CB., Batugo, M., et al.[2015]

NCX 139, a new compound combining latanoprost amide and a nitric oxide (NO) donor, significantly lowered intraocular pressure (IOP) in both rabbit and dog models of ocular hypertension, demonstrating its potential as an effective treatment for glaucoma.

In contrast to its des-nitro analog, NCX 139 showed a notable NO-mediated vascular relaxant effect and was more effective in reducing IOP compared to standard treatments like bimatoprost and latanoprost, particularly in hypertensive conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dual acting compound with latanoprost amide and nitric oxide releasing properties, shows ocular hypotensive effects in rabbits and dogs. Impagnatiello, F., Borghi, V., Gale, DC., et al.[2018]

Latanoprostene bunod (LBN) and NCX 470 are novel glaucoma treatments that combine prostaglandin analogs with nitric oxide (NO) donors, showing greater intraocular pressure (IOP) reduction compared to traditional treatments like latanoprost and timolol in clinical settings.

LBN demonstrated superior IOP-lowering efficacy in patients, while NCX 470 was more effective than bimatoprost in animal models, highlighting the potential of NO-donating therapies in managing ocular hypertension and glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostaglandin analogues and nitric oxide contribution in the treatment of ocular hypertension and glaucoma. Impagnatiello, F., Bastia, E., Almirante, N., et al.[2023]

In a study of 94 black patients with open-angle glaucoma or ocular hypertension, both bimatoprost 0.03% and travoprost 0.004% significantly lowered intraocular pressure (IOP), but bimatoprost was more effective, with 85% of patients achieving at least a 20% reduction in IOP compared to 68% for travoprost.

Bimatoprost also resulted in a higher percentage of patients experiencing greater than 40% IOP reduction (31.9% vs. 20.9% for travoprost), while both treatments had similar safety profiles with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing bimatoprost and travoprost in black Americans. Noecker, RJ., Earl, ML., Mundorf, TK., et al.[2022]

NCX 470, a nitric oxide-donating bimatoprost, effectively reversed increases in intraocular pressure (IOP) and improved ocular blood flow and retinal function in a rabbit model of ischemia/reperfusion, indicating its potential for enhancing ocular health.

The treatment not only lowered IOP but also restored retinal responses and reduced oxidative stress markers, suggesting that NCX 470 may improve retinal physiology through mechanisms beyond just lowering IOP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NCX 470 Restores Ocular Hemodynamics and Retinal Cell Physiology After ET-1-Induced Ischemia/Reperfusion Injury of Optic Nerve and Retina in Rabbits. Bastia, E., Sgambellone, S., Lucarini, L., et al.[2022]

NCX 470 (0.1%) significantly reduced intraocular pressure (IOP) more effectively than Lumigan® (bimatoprost, 0.01%) in both single and repeated dosing studies involving Beagle dogs, with average IOP decreases of -6.06 mmHg for NCX 470 compared to -3.60 mmHg for Lumigan.

The enhanced IOP-lowering effect of NCX 470 is attributed to its ability to increase aqueous humor outflow facility and uveoscleral outflow, without altering aqueous flow, as demonstrated in non-human primates and 3D human trabecular meshwork constructs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NCX 470 Reduces Intraocular Pressure More Effectively Than Lumigan in Dogs and Enhances Conventional and Uveoscleral Outflow in Non-Human Primates and Human Trabecular Meshwork/Schlemm's Canal Constructs. Galli, C., Bastia, E., Hubatsch, DA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prostaglandin analog treatment of glaucoma and ocular hypertension. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Intraocular Pressure-Lowering Activity of NCX 470, a Novel Nitric Oxide-Donating Bimatoprost in Preclinical Models. [2015]

3. England pubmed.ncbi.nlm.nih.gov

A dual acting compound with latanoprost amide and nitric oxide releasing properties, shows ocular hypotensive effects in rabbits and dogs. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Prostaglandin analogues and nitric oxide contribution in the treatment of ocular hypertension and glaucoma. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Comparing bimatoprost and travoprost in black Americans. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

NCX 470 Restores Ocular Hemodynamics and Retinal Cell Physiology After ET-1-Induced Ischemia/Reperfusion Injury of Optic Nerve and Retina in Rabbits. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

NCX 470 Reduces Intraocular Pressure More Effectively Than Lumigan in Dogs and Enhances Conventional and Uveoscleral Outflow in Non-Human Primates and Human Trabecular Meshwork/Schlemm's Canal Constructs. [2023]