Clinical Publication Abstracts
Note: We have provided here several
abstracts of Dr. Mark Babizhayev's research publications, however to
review all of the publications regarding the treatment of cataracts with
n-acetylcarnosine eye drops please visit the following public medical database
you are there simply type in Dr. Babizhayev's last name only (Babizhayev)
into the search field at the top of the page and you will access all of
the available publications on this exciting breakthrough in the non-surgical
treatment of cataracts.
1: Rejuvenation Res. 2004
Rejuvenation of visual functions in older adult drivers
and drivers with cataract during a short-term administration of N-acetylcarnosine
lubricant eye drops.
Vision Products, Inc. Moscow Division, Ivanovskaya 20, Suite 74, Moscow 127434,
Russian Federation. x
The purpose of this study
was to examine using the original halometer glare test of the type of visual
impairment mediated by the increased glare sensitivity (halos) and associated
with poorer visual function in both the better and worse eyes of older adult
drivers and older drivers with cataract. The clinically validated (by Innovative
Vision Products Inc.) formula of 1% N-acetylcarnosine (NAC) lubricant eye drops
were applied topically to the eyes of older drivers to reduce glare disability
and improve distance acuities for driving. This was a randomized, double-blind,
placebo-controlled study. The examined subjects consisted of 65 older adults,
with cataract in one or both eyes, and 72 adult drivers who did not have cataract
in either eye. In the control group, comparison with baseline values showed
some variability of data in gradual worsening of glare sensitivity at red and
green targets and minimal VA changes over 4 months. In the NAC-treated group,
4-month follow-up generally showed an improvement in VA and a significant improvement
in glare sensitivity at red and green targets was documented in worse and better
eyes using a critical cut point halometer score for driving. The NAC-treated
eyes had statistically significant difference in VA, glare sensitivity compared
with the control group ( p < 0.001) at 4-month timepoint of treatment, as
supported by the overall t-test results of the ratio of the follow-up data to
the baseline values. Tolerability of NAC eyedrops was good in almost all patients,
with no reports of ocular or systemic adverse effects. It would be advisable
for traffic safety if a Halometer glare sensitivity test was implemented for
vehicles and/or was regularly added to the requirements for a driver's licence.
The results of this study provide a substantial basis for further evaluation
of NAC in the treatment and prevention of vision impairment in the older population
of drivers for legal driving. The developed ophthalmic drug NAC formula showed
potential for the non-surgical treatment of age-related cataracts.
PMID: 15139774 [PubMed - indexed for MEDLINE]
1: Peptides. 2001 Jun;22(6):979-94.
natural histidine-containing dipeptide, as a potent ophthalmic drug in treatment
of human cataracts.
Babizhayev MA, Deyev AI, Yermakova VN, Semiletov YA, Davydova NG, Kurysheva
NI, Zhukotskii AV, Goldman IM.
Innovative Vision Products, Inc., County of New Castle, DE 19810, USA.
A study was designed to document and quantify the changes in lens clarity over
6 and 24 months in 2 groups of 49 volunteers (76 eyes) with an average age of
65.3 +/- 7.0 enrolled at the time of diagnosis of senile cataracts of minimal
to advanced opacification. The patients received N-acetylcarnosine, 1% sol (NAC)
(26 patients, 41 eyes = Group II), placebo composition (13 patients, 21 eyes)
topically (two drops, twice daily) to the conjunctival sac, or were untreated
(10 patients, 14 eyes); the placebo and untreated groups were combined into
the control (reference) Group I. Patients were evaluated upon entry, at 2-month
(Trial 1) and 6-month (Trial 2)-intervals for best corrected visual acuity (b/c
VA), by ophthalmoscopy and the original techniques of glare test (for Trial
1), stereo cinematographic slit-image and retro-illumination photography with
subsequent scanning of the lens. The computerized interactive digital analysis
of obtained images displayed the light scattering/absorbing centers of the lens
into 2-D and 3-D scales. The intra-reader reproducibility of measuring techniques
for cataractous changes was good, with the overall average of correlation coefficients
for the image analytical data 0.830 and the glare test readings 0.998. Compared
with the baseline examination, over 6 months 41.5% of the eyes treated with
NAC presented a significant improvement of the gross transmissivity degree of
lenses computed from the images, 90.0% of the eyes showed a gradual improvement
in b/c VA to 7-100% and 88.9% of the eyes ranged a 27-100% improvement in glare
sensitivity. Topographic studies demonstrated less density and corresponding
areas of opacification in posterior subcapsular and cortical morphological regions
of the lens consistent with VA up to 0.3. The total study period over 24 months
revealed that the beneficial effect of NAC is sustainable. No cases resulted
in a worsening of VA and image analytical readings of lenses in the NAC-treated
group of patients. In most of the patients drug tolerance was good. Group I
of patients demonstrated the variability in the densitometric readings of the
lens cloudings, negative advance in glare sensitivity over 6 months and gradual
deterioration of VA and gross transmissivity of lenses over 24 months compared
with the baseline and 6-month follow-up examinations. Statistical analysis revealed
the significant differences over 6 and 24 months in cumulative positive changes
of overall characteristics of cataracts in the NAC-treated Group II from the
control Group I.The N-acetylated form of natural dipeptide L-carnosine appears
to be suitable and physiologically acceptable for nonsurgical treatment for
Randomized Controlled Trial
PMID: 11390029 [PubMed - indexed for MEDLINE]
1: Drugs R D. 2002;3(2):87-103.
Efficacy of N-acetylcarnosine in the treatment of cataracts.
MA, Deyev AI, Yermakova VN, Semiletov YA, Davydova NG, Doroshenko VS, Zhukotskii
AV, Goldman IM.Innovative Vision Products, Inc., County of Newcastle, Delaware,
USA. PURPOSE: To evaluate the effects of 1% N-acetylcarnosine (NAC) solution
on lens clarity over 6 and 24 months in patients with cataracts. TRIAL DESIGN:
Randomised, placebo-controlled study. PARTICIPANTS: 49 subjects (76 affected
eyes) with an average age of 65.3 +/- 7.0 years with a diagnosis of senile cataract
with minimum to advanced opacification in various lens layers.
METHODS: 26 patients (41 eyes) were allocated to topical NAC 1% eyedrops
twice daily. The control group consisted of 13 patients (21 eyes) who received
placebo eyedrops and 10 patients (14 eyes) who did not receive eyedrops.
MAIN OUTCOME MEASURES: All patients were evaluated at entry and followed up
every 2 months for a 6-month period (trial 1), or at 6-month intervals for a
2-year period (trial 2), for best-corrected visual acuity and glare testing.
In addition, cataract was measured using stereocinematographic slit-images and
retro-illumination examination of the lens. Digital analysis of lens images
displayed light scattering and absorbing centres in two- and three-dimensional
RESULTS: The overall intra-reader reproducibility of cataract measurements
(image analysis) was 0.830, and glare testing 0.998. After 6 months, 90% of
NAC-treated eyes showed improvement in best corrected visual acuity (7 to 100%)
and 88.9% showed a 27 to 100% improvement in glare sensitivity. Topographic
studies indicated fewer areas of posterior subcapsular lens opacity and 41.5%
of treated eyes had improvement in image analysis characteristics. The overall
ratios of image analysis characteristics at 6 months compared with baseline
measures were 1.04 and 0.86 for the control and NAC-treated group, respectively
(p < 0.001). The apparent benefits of treatment were sustained after 24 months'
treatment. No treated eyes demonstrated worsening of vision. The overall visual
outcome in the control group showed significant worsening after 24 months in
comparison with both baseline and the 6-month follow-up examination. The overall
clinical results observed in the NAC-treated group by the 24-month period of
examination differed significantly (p < 0.001) from the control group in
the eyes with cortical, posterior subcapsular, nuclear or combined lens opacities.
Tolerability of NAC eyedrops was good in almost all patients, with no reports
of ocular or systemic adverse effects.
CONCLUSION: Topical NAC shows potential for the treatment and prevention
Randomized Controlled Trial
PMID: 12001824 [PubMed - indexed for MEDLINE]
1: Biochemistry (Mosc). 2000 May;65(5):588-98.
1: Peptides. 2001 Jun;22(6):979-94.
The natural histidine-containing dipeptide
Nalpha-acetylcarnosine as an antioxidant for ophthalmic use.
Babizhayev MA, Yermakova
VN, Semiletov YA, Deyev AI. Innovative Vision Products Inc., County of New Castle,
Delaware 19810, USA.
The naturally occurring compound Nalpha-acetylcarnosine is proposed as a prodrug
of L-carnosine that is resistant to enzymatic hydrolysis by carnosinase. Eyes
of rabbits were treated with 1% Nalpha-acetylcarnosine, L-carnosine, or placebo
and extracts of the aqueous humor from the anterior eye chamber were analyzed
for imidazole content by reverse-phase analytical high performance liquid chromatography
(HPLC) and thin-layer (TLC) and ion-exchange chromatographic techniques. Topical
administration of pure L-carnosine to the rabbit eye did not lead to accumulation
of this compound in the aqueous humor over 30 min in concentration exceeding
that in the placebo-treated matched eye. Nalpha-Acetylcarnosine showed dose-dependent
hydrolysis in its passage from the cornea to the aqueous humor, releasing L-carnosine
after l5-30 min of ocular administration of the prodrug in a series of therapeutic
modalities: instillation < or = subconjunctival injection < or = ultrasound-induced
phoresis. Different treatment techniques showed excellent toleration of 1%Nalpha-acetylcarnosine
by the eye. Once in the aqueous humor, L-carnosine might act as an antioxidant
and enter the lens tissue when present at effective concentrations (5-l5 mM).
The advantage of the ophthalmic prodrug Nalpha-acetylcarnosine and its bioactivated
principle L-carnosine as universal antioxidants relates to their ability to
give efficient protection against oxidative stress both in the lipid phase of
biological membranes and in aqueous environments. N-alpha-Acetylcarnosine is
proposed for treatment of ocular disorders that have a component of oxidative
stress in their genesis (Cataracts, Glaucoma, Retinal Degeneration, Corneal
Disorders, Ocular Inflammation, Complications of diabetes mellitus, and systemic
PMID: 10851037 [PubMed - indexed for MEDLINE]
1: Clin 96 Oct 15;254(1):1-21.Chim Acta. 19
Erratum in: Clin Chim Acta 1997 Mar 18;259(1-2):199-201.
N alpha-acetylcarnosine is a prodrug of L-carnosine
in ophthalmic application as antioxidant.
Babizhayev MA, Yermakova VN, Sakina NL, Evstigneeva RP, Rozhkova EA, Zheltukhina
Moscow Helmholtz Research Institute of Eye Diseases, Russian Federation.
occurring compound N alpha-acetylcarnosine (NAC) is proposed as the prodrug
of L-carnosine (C) resistant to enzymatic hydrolysis by human serum carnosinase.
Rabbit eyes were treated with 1% NAC, C or placebo and extracts of the aqueous
humor from the anterior eye chamber were analyzed for imidazole content by reverse
phase analytical high performance liquid chromatography (HPLC), thin-layer (TLC)
and ion-exchange chromatographic techniques. The topical administration of pure
C to the rabbit eye did not lead to accumulation of this compound in the aqueous
humor over 30 min in concentration exceeding that in the placebo-treated matched
eye. NAC showed dose-dependent hydrolysis in its passage from the cornea to
the aqueous humor, releasing C after 15. 30 min of ocular administration of
prodrug in a series of therapeutical modalities: instillation < or = subconjunctival
injection < or = ultrasound induced phoresis. Different treatment techniques
showed excellent toleration of 1% NAC by the eye. Once in the aqueous humor,
C might act as an antioxidant and enter the lens tissue when present at effective
concentrations (5-15 mmol/l). The advantage of the ophthalmic prodrug NAC and
its bioactivated principle C as universal antioxidants relates to their ability
to give efficient protection against oxidative stress both in the lipid phase
of biological membranes and in an aqueous environment. NAC is proposed to
treat ocular disorders, which have the component of oxidative stress in their
genesis (cataracts, glaucoma, retinal degeneration, corneal disorders, ocular
inflammation, complications of diabetes mellitus, systemic diseases).
PMID: 8894306 [PubMed - indexed for MEDLINE]
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