A first-of-its-kind medical food may provide an additional treatment option for glaucoma patients and those at risk for the disease. The ingredients in Guardion Health Sciences’ Glaucocetin were demonstrated in a placebo-controlled trial¹ to reverse mitochondrial dysfunction, which is now thought to be a major contributor to optic nerve damage and vision loss in glaucoma patients, says David Evans, PhD, MBA, chief science officer at Guardion Health Sciences. In fact, says Dr. Evans, some glaucoma specialists who prescribe Glaucocetin have seen a reversal of visual field loss.

“There is increasing evidence that oxidative stress, free radical formation, and mitochondrial dysfunction can lead to ganglion cell death and glaucoma damage,” says Seth D. Potash, MD, an ophthalmologist and glaucoma specialist at SightMD in Westchester, New York, who prescribes Glaucocetin. For many glaucoma patients, factors other than intraocular pressure (IOP) control contribute to their condition and disease progression.

Key Ingredients

A medical food is designed to reverse a specific dietary insufficiency that can’t be corrected by diet alone; it should be taken under a health-care provider’s supervision, Dr. Evans says. Medical foods are a recognized category by the FDA, and have more stringent requirements than supplements.

Glaucocetin’s design includes anti-inflammatory, antioxidant, and neuroprotective ingredients. It is focused on supporting overall retinal health, improved ocular circulation, and proper mitochondrial function in the eye and optic nerve, Dr. Evans says. The product contains a unique and wide range of specialized ingredients that aren’t found in any other compound.

One of the ingredients, N-acetylcysteine, is a precursor to glutathione, the most potent antioxidant produced in the body to fight free-radical damage. Studies^2,3 have shown that glaucoma patients have significantly reduced levels of glutathione, which can potentially expose the body and the optic nerve to excessive levels of free-radical damage.

Another ingredient, gingko biloba, has been shown to improve ophthalmic artery blood flow. Studies^4,5 suggest that glaucoma patients have reduced ocular blood flow, and it is hypothesized that gingko could help reverse these circulatory deficiencies.

“Glaucocetin is sourced with the highest quality ingredients and integrated with biochemical and nutritional input to ensure adequate stability and absorption of these nutrients,” says Shamil S. Patel, MD, MBA, surgeon and owner of Eye Physicians & Surgeons of Arizona in Scottsdale, who prescribes the product.

Glaucocetin is the only medical food that has been formulated by an expert glaucoma specialist, Robert Ritch, MD, FACS, FARVO, former professor of ophthalmology and former chief of glaucoma services at the New York Eye and Ear Infirmary of Mount Sinai in New York City, New York.

“Decades of research and commitment to neuroprotection have culminated in this medical food,” Dr. Patel says.

Ease of Use

Glaucocetin contains key ingredients that Dr. Potash has recommended to his patients for years, in addition to other important supplements. “It contains an outstanding combination of nutritional supplements in one single product,” he says. “It avoids the need for multiple bottles of supplements.”

The product comes in a powder form, which patients mix with any liquid of their choosing. Capsules are under development, and Guardion plans to offer capsules either as the only option or as a second option with the powder form, Dr. Evans says.

Dr. Patel has received positive feedback from patients who have used Glaucocetin, and has had an excellent continuation rate. Patients have commented that taking the product is easy. Few patients have had issues with the taste; none stopped taking it for that reason. Glaucocetin should be consumed daily. To obtain Glaucocetin, patients need a doctor authorization code.

Clinical Applications

Dr. Potash recommends Glaucocetin to patients with moderate to severe glaucoma, particularly those who are progressing despite consistently well-controlled IOP. He recommends the product to patients with comorbid conditions, such as migraines, Raynaud phenomenon, sleep apnea, and orthostatic hypotension, regardless of their glaucoma stage. Dr. Patel would also recommend the product to patients with significant risk factors or family history of glaucoma who desire preventive options in addition to monitoring. Because many of Glaucocetin’s compounds may have neuroprotective and circulation benefits, the implications in treatment for a variety of central nervous system and cognitive diseases is endless, Dr. Potash adds.

Another Study Under Way

A randomized, prospective clinical trial⁶ of 150 patients at Wills Eye Hospital in Philadelphia is currently evaluating Glaucocetin’s effects on glaucoma patients’ visual acuity, contrast sensitivity, visual field progression, OCT, and pattern electroretinogram in the hopes of proving that this medical food has a positive clinical impact on glaucoma patients with both central and peripheral visual field impairment, says Dr. Potash, who is eagerly anticipating the trial’s results in mid-2022. The study is also examining the impact of circulating glutathione in patients.

“The only thing holding me back from prescribing Glaucocetin more routinely is the fact there is no definitive evidence that it either slows or prevents glaucoma progression,” Dr. Potash says. “But I’m optimistic that Glaucocetin’s benefits will be confirmed in this clinical trial.”

The precursor compound of Glaucocetin, Glaucohealth, has been successfully used clinically since 2016 by Dr. Ritch.¹ GP

References

1. Ritch R. GlaucoCetin case report. Poster presented at: 28th Annual Meeting of the American Glaucoma Society; March 2018; New York, New York.
2. Mousa A, Kondkar AA, Al-Obeidan SA, et al. Association of total antioxidants level with glaucoma type and severity. Saudi Med J. 2015 Jun;36(6):671-677. doi: 10.15537/smj.2015.6.10697
3. Gherghel D, Griffiths HR, Hilton EJ, Cunliffe IA, Hosking SL. Systemic reduction in glutathione levels occurs in patients with primary open-angle glaucoma. Invest Ophthalmol Vis Sci. 2005;46(3):877-883. doi:https://doi.org/10.1167/iovs.04-0777
4. Chung HS, Harris A, Kristinsson JK, Ciulla TA, Kagemann C, Ritch R. Ginkgo biloba extract increases ocular blood flow velocity. J. Ocul Pharmacol Ther. 1999;15(3):233-240. doi: 10.1089/jop.1999.15.233
5. Dewi Sari M, Sihotang DA, Lelo A. Ginkgo biloba extract effect on oxidative stress marker malonildialdehyde, redox enzyme gluthation peroxidase, visual field damage, and retinal nerve fiber layer thickness in primary open angle glaucoma. Intl J Pharm Tech Res. 2016;9(3):158e66.
6. Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin. Clinicaltrials.gov . Accessed Aug. 4, 2021. https://clinicaltrials.gov/ct2/show/NCT04784234