Dr. Babizhayev Warning
INNOVATIVE VISION PRODUCTS, INC.
Delaware Office - Moscow Office:
3511 Silverside Road, Ivanovskaya 20,
County of New Castle, Moscow 127434
Delaware USA 19810 Russia
Re: N-Acetylcarnosine Statement of Fact
February 3rd, 2004
To Whom It May Concern,
For the record I wish to confirm that I am Mark Babizhayev PhD, MA, and that I, along with my team of fellow research scientists, made the discovery and carried out all of the now published, research over the last eleven years for the application of N-Acetylcarnosine to address senile cataracts and related ocular disorders. I also wish to state that my company, Innovative Vision Products (IVP), is the holder of the worldwide patents for the use of N-Acetylcarnosine to address senile cataracts. In addition to our 1993 European Union patent application, we have filed patent applications in the United States and additional countries around the globe. The application of NAC for the treatment of cataracts has been protected by the PCT patents by our group."[Ed.- They are as follows: Babizhayev MA, Bozzo Costa E. Composizioni farmaceutiche contenenti N-acetilcarnosina per il trattamento della cataratta. Italian Patent A61K gruppo37/00 20122 MI, Priority 15.10.1993 and Babizhayev MA, Bozzo Costa, E. Pharmaceutical compositions containing N-acetylcarnosine for the treatment of cataract. Patent PCT/EP 94/03340 SCB 238 PCT, 10.10.1994].
Technical Statement
Firstly I wish to emphasize a very important point and that is that there are serious potential risks to ocular health with the long term application of any preparation used in the eye and therefore usage should always be carefully considered and monitored by patients and their physicians. As stated repeatedly in my publications there is a very fragile and highly specific balance of purity for this formulation that must be maintained to ensure the safe and effective use of N-Acetylcarnosine eye drops. Therefore, it must be clearly understood that it is only the formula made to this specific purity and methodology, the patented formula, that has been tested and proven in animal and in human clinical trials to be efficacious and most importantly, safe in long-term use.
Innovative Vision Products (IVP) is the patent holder and oversees the manufacture of the only clinically proven N-Acetylcarnosine formula such as supplied in Nu-Eyes ™. For public safety I established IVP to ensure that the highest qualities of standards are maintained for formula production control in a cGMP facility.
Warning
Unfortunately there are a few immoral companies who are in patent violation, attempting to capitalize on this discovery, which are illicitly manufacturing and selling N-Acetylcarnosine for senile cataracts without the proprietary benefit of the specific level of purity and methodology that was established in clinical trials required to ensure efficacy and safety for eye use. A number of these companies are actually referencing my research, to promote their sub-standard product, thereby damaging my reputation. Therefore as the publisher of much research on this subject, I feel a responsibility to inform consumers of the fraudulent and dangerous products being promoted to the public.
Some manufacturers are claiming that simple L-carnosine when applied topically to the eye without protection to enzymatic hydrolysis, can be delivered by eye drop direct into the aqueous humor or in the lens but this has not been demonstrated clinically by verified trials. There are problems with this claim. On the surface of the eye there naturally exist enzymes called carnosinase or aminopeptidases which break down any spare carnosine topically applied to the eye which will immediately start to breakdown any straight L-carnosine put into the eye into the two amino acid moieties that make up the di-peptide L-carnosine. These moieties include histidine. The continual release of L-histidine can release histamine in the eye via the histidine decarboxylase enzymatic activity and this could cause a damage to the eye tissue structures and induce inflammation or cascade of allergic reactions that is of great concern to professionals and our years of research on the subject at the Helmholtz Eye Institute in Moscow validates my view. When pure carnosine is converted to histamine during its metabolic breakdown, in no way it can affect cataracts, but instead can propagate cataract progression as histamine is acting as an active pro-oxidant in the presence of transition metal ions in biological tissues and fluids.
In addition some are attempting to make their products more attractive with the addition of vitamins such as vitamin A and E. These vitamins, while by themselves may be beneficial to the eye, have branched hydrocarbon skeletons that inhibit the activity of N-Acetylcarnosine, particularly in the critical cornea and conjunctiva of the eye. More importantly combinations of vitamins and N-Acetylcarnosine have not been clinically researched for either efficacy or safety leaving the possibility for damage of the eye surface with long-term use, as was shown with L-Carnosine and vitamins in our experimental trials. Therefore as the publisher of much research on this subject I feel a responsibility to inform consumers of the fraudulent and dangerous products being promoted to the public.
The good news is that there is a very simple way to determine if one is purchasing the safe, patented product formula. The following statement is provided on the eye-drop box labels by our approved private label distributors,
Nu-Eyes ™ provided by BioNational Pharmaceuticals is one such distributor. Finding this phrase on the box ensures that you have the exact same formula and purity, of eye drop, that was proven to be safe in our clinical trials.
To conclude, for public safety we shall be vigorously defending our patents and issuing injunctions against distributors of non-approved N-Acetylcarnosine anti-cataract eye-drops, furthermore we shall be seeking damages where appropriate.
Cordially,
Mark Babizhayev MA, PhD
