HerbalEGram: Volume 5, Number 10, October 2008

A recent clinical trial suggests that a new, proprietary combination of the popular Mirtoselect® bilberry extract and Pycnogenol® French Maritime Pine Bark extract may improve and possibly prevent glaucoma. ^1,2

In their first collaboration, Indena S.p.A.  of Milan, Italy and Horphag Research Ltd. of Geneva, Switzerland have produced a unique herbal preparation called  Mirtogenol®, a combination of the Indena’s Mirtoselect® extract of bilberry (Vaccinium myrtillus) and Horphag’s Pycnogenol® extract of French Maritime pine bark (Pinus pinaster). Together these extracts have demonstrated improvement of blood flow and intraocular pressure in the eyes of ophthalmic patients.^1,2

Both Indena and Horphag have published separate studies on glaucoma and inter-ocular hypertension, which is the only modifiable factor in glaucoma, according to Frank Schonlau, PhD, of Horphag and the lead author of the Mirtogenol study (email, September 10, 2008). By using Pycnogenol to improve eye pressure and Mirtoselect to target the eye, the companies thought that it might be possible to improve glaucoma. ¹

“We hypothesized that substances which can normalize capillary filtration and improve blood micro-circulation would restore the balance of aqueous humor entering the eye and the amount drained from it back to the venous system,” Schonlau wrote. “Intraocular hypertension may result from too much liquid leaving capillaries in the eye or too little drained from it. Mirtoselect has been shown in animal studies to strengthen capillary walls of blood vessels in the eye and decrease the fluid released into the eye. Pycnogenol improves the endothelial function which improves blood flow through the vessel instead of pressure building up and liquid seeping through the vessel wall.”

The controlled, unblinded trial was conducted over 6 months at the University of Chieti-Pescara in San Valentino, Italy with 38 subjects who had no signs of glaucoma. The 20 subjects in the Mirtogenol group received one pill in the morning and one in the evening daily. Each pill contained 40mg of the Mirtoselect bilberry extract and 80mg of Pycnogenol for a daily total of 80mg of Mirtoselect and 160mg of Pycnogenol. The remaining 18 subjects were in the control group and were untreated and did not receive a placebo. After 6 months, 19 of the patients in the Mirtogenol group and 1 patient in the control group had lower intraocular pressure (IOP). The average IOP was lowered to 22 mmHG ± 2.3 from baseline after six months using the Goldmann applanation tonometer for measurements.^1,2

This project was a natural fit for both Indena and Horphag due to their similar business practices and approach to quality, clinically-tested botanical ingredients. Scientific teams from both companies worked together on the formulation and study protocol. They are reportedly working together to finalize patent rights, exclusivity agreements and other details with regard to Mirtogenol and indicated their interest in continuing this collaborative success with other projects (Cheryl Costanzo, email, September 12, 2008).

Bilberry, a form of European blueberry, and French maritime pine bark have been used in Europe as a food and traditional medicine, respectively, for centuries with a high degree of safety. Indena has been the world leader in pursuing scientific and clinical research on bilberry extract. Horphag has been marketing its proprietary Pycnogenol extract in Europe and worldwide for several decades. The companies note that they will conduct further studies on this proprietary combination as well as investigate its possible use with other eye medications.

Christian Artaria, Indena’s Marketing Director, cautions that a physician should be consulted by consumers experiencing eye problems. “Both extracts in Mirtogenol™ have a well-documented history of safety supported by scientific studies as well as years of use by millions of consumers. There are no known [adverse] side effects associated with either of the extracts individually or in combination. When taking Mirtogenol™ in combination with other medications for eye health, it is best to consult with a doctor to ensure a safe and effective course of therapy based on the patient’s individual needs.” (email, October 10, 2008) 

Regarding further joint efforts, Artaria wrote, “We [Indena] believe that we must share our skills and know-how with customers in order to come up with new products meeting a market need.  We hope this excellent experience with Horphag can serve as a basis for future successful collaborations.”

Artaria noted that Indena and Horphag are currently working on a second clinical trial on Mirtogenol as well as another joint-venture project.

An ABC HerbClip summarizing the details of the Mirtogenol clinical trial is available here.

—Cassandra Johnson, Mark Blumenthal

References

1. Steigerwalt RD, Gianni B, Paolo M, et al. Effects of Mirtogenol® on ocular blood flow and intraocular hypertension in asymptomatic subjects. Molecular Vision. 2008; 14:1288-1292.