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

- 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?%2FFgzNhl5slcNpxEKcevFRrHdP1%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.   For more information, please contact: Syneos Health Limited Christopher [email protected]+44(0)20-7632-1826 Consilium Strategic Communications Mary-Jane Elliott, Chris Welsh, Sarah [email protected]+44(0)20-3709-5700