New Data Indicate That EyeMax Mono, a Lens Tailored Specifically for Patients With Dry Age-related Macular Degeneration (AMD), Offers Significant Improvement in Visual Function

London (ots/PRNewswire) -

EyeMax Mono implantation results in an improved mean visual acuity
of 18 ETDRS letters and 57% increase in mean reading speed

LEH Pharma Ltd, a leading provider of innovative technologies for
macular disorders, today announces new data published in the Journal
of Refractive Surgery[1], suggesting that EyeMax Mono offers benefits
in terms of visual function for people with dry age-related macular
degeneration (AMD). EyeMax Mono is an intraocular lens (IOL)
specifically designed to deliver improved visual outcomes for
patients with dry AMD. [2]

The data show that vision improved in all patients receiving
EyeMax Mono, with a mean visual acuity improvement of 18 ETDRS[*]
letters and a 57% increase in mean reading speed (28 ± 19 to 44 ± 31
words per minute). The study was designed to assess the safety and
initial outcomes following implantation of EyeMax Mono in patients
with bilateral dry AMD. At 2 months postoperative follow-up the mean
corrected distance visual acuity (CDVA; LogMAR) had increased from
0.93 ± 0.22 to 0.59 ± 25, and a corresponding increase in mean
corrected near visual acuity (CNVA) was also observed (from 1.05 ±
0.18 to 0.73 ± 0.26).

These data, in a small cohort of patients (n=7; 8 eyes) with
severe dry AMD and a mean age of 77 years, build on a recently
published, consecutive, case series of 244 eyes implanted with EyeMax
Mono, where gains in CDVA and CNVA were also observed.[2] Data from
an independent study of 96 eyes was presented as a poster at the
American Academy of Ophthalmology meeting in Chicago.[3]

Dr Scott Robbie, lead author and Chief Scientific Officer, LEH
Pharma, said, "Age-related macular degeneration is a progressive
disease, with a significant unmet clinical need and no cure. In
contrast to standard, monofocal lenses, EyeMax Mono is a new lens
option that optimises image quality across the macula for patients
using eccentric fixation or who are at higher risk of this. This
technology allows patients to maximise their use of preferred retinal
loci in healthier areas of the macula."

Microperimetry demonstrated that patients are able to use
healthier areas of macula after EyeMax Mono implantation, as shown by
shifts in fixation over time, improvements in threshold sensitivities
and more stable fixation all of which correlate with improved reading
speed. In this study, microperimetry threshold sensitivities improved
from 8.2 ± 4.6 to 12.0 ± 5.6 dB and fixation improved from 77% ± 17%
to 91% ± 11%. Incremental improvements indicate a neuroadaptive
component to gains in visual function. Crucially, no rehabilitation
or training was required to achieve this result.[1]

Dr Bobby Qureshi, Chief Executive Officer and Founder, LEH Pharma,
said "One of our main aims in treating patients with dry AMD is to
help them to achieve improved independence due to better visual
acuity and function, allowing them to undertake daily tasks, such as
reading. These important results add to the growing body of evidence
for EyeMax Mono in improving patient outcomes."

There were no intraoperative or postoperative complications, and
results suggest that EyeMax Mono has a safety profile comparable to
that of standard monofocal lenses. EyeMax Mono can be implanted using
simple, well-established techniques, following the same surgical
principles as insertion of a standard intraocular lens following
cataract removal.[2]

EyeMax Mono has been implanted in more than 2,500 eyes, in
patients from 10 countries. LEH Pharma is currently advancing
regulatory approvals across countries.

Notes for editors:

About LEH Pharma

LEH Pharma is a leading provider of innovative technologies for
macula disorders. The Company was formed in 2011 by a group of
pioneering surgeons, and is supported by a network of world-leading
ophthalmologists and scientists.

For more information, please visit LEH Pharma's website at
http://www.lehpharma.com

About EyeMax Mono

Conceived by eye surgeon Dr Bobby Qureshi and optical physicist
Professor Pablo Artal, EyeMax Mono is a revolutionary breakthrough
for AMD sufferers. It is a single-piece, soft, hydrophobic, IOL for
use in patients with dry AMD, and its tailored optical design
optimises image quality across the macula.[2] Utilising transverse
asphericity to extend the breadth of focus, EyeMax Mono improves
image quality, in any area of the macula used by the patient.[2]

EyeMax Mono can be implanted with minimal intra- or post-operative
complications.[2] EyeMax Mono can be implanted using simple,
well-established surgical techniques that follow the same surgical
principles as insertion of a monofocal lens following cataract
removal.[2]

EyeMax Mono has been implanted in more than 2,500 eyes, in
patients from 10 countries. LEH Pharma is currently advancing
regulatory approvals in other countries.

The current standard of care for patients with dry AMD is limited
to lifestyle changes, nutritional supplements, use of magnification
aids and training to use peripheral vision.[4],[5]

About age related macular degeneration (AMD)

It is estimated that there are 170 million people living with AMD
around the world and of these, dry AMD accounts for 85-90% of all
cases.[6],[7] AMD, including both dry and wet forms, is the leading
cause of irreversible blindness worldwide, affecting 10-13% of adults
over 65 years of age.[8] AMD causes central visual loss leading to
gaps in images, such as words on pages, bus numbers, faces and the
television. Vision becomes distorted, colours can fade and dark
adaptation can be impaired. Driving may become impossible.[9]

* ETDRS - Early Treatment Diabetic Retinopathy Study

REFERENCES

1. Robbie SJ, et al. Initial clinical results with a novel
monofocal-type intraocular lens for extended macular vision in
patients with macular degeneration. J Refract Surgery 2018
34(11):718-725. https://doi.org/10.3928/1081597X-20180831-01 Accessed
November 2018.

2. Qureshi MA, et al. Consecutive case series of 244-age-related
macular degeneration patients undergoing implantation with an
extended macular vision IOL. Eur J Ophthalmol 2018;28:198-203.

3. Badala F, et al. EyeMax Mono: A New IOL for patients with
cataract and macular disease. https://aao.apprisor.org/epsView.cfm?%2
FFgzNhl5slcNpxEKcevFRrHdP1%2BaMwpKDXwMyWmQ6VcrhsTFfsBEmA%3D%3D .
Accessed November 2018.

4. Maniglia M, et al. Rehabilitation approaches in macular
degeneration patients. Front Syst Neurosci 2016;10:107.

5. Velez-Montoya R, et al. Current knowledge and trends in
age-related macular degeneration: genetics, epidemiology, and
prevention. Retina 2014;34:423-441.

6. Wong WL, et al. Global prevalence of age-related macular
degeneration and disease burden projection for 2020 and 2040: a
systematic review and meta-analysis. Lancet Glob Health
2014;e106-e116.

7. Narayanan R, Kuppermann BD. Hot topics in dry AMD. Curr Pharm
Des 2017;3:542-546.

8. Schmidt-Erfurth U, et al. Guidelines for the management of
neovascular age-related macular degeneration by the European Society
of Retina Specialists (EURETINA). Br J Ophthalmol 2014;98:1144-1167.

9. Waugh N, et al. Treatments for dry age-related macular
degeneration and Stargardt disease: a systematic review. Health
Technol Assess 2018;22:1-168.

ots Originaltext: LEH Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
, please contact:
Syneos Health Limited
Christopher Goddard
Christopher.goddard@syneoshealth.com
+44(0)20-7632-1826

Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Sarah Wilson
LEHPharma@consilium-comms.com
+44(0)20-3709-5700

Original-Content von: LEH Pharma, übermittelt durch news aktuell