LEH Pharma announced new data published in the Journal of Refractive Surgery, suggesting that EyeMax Mono offers benefits in terms of visual function for people with dry age-related macular degeneration (AMD). EyeMax Mono is an IOL specifically designed to deliver improved visual outcomes for patients with dry AMD.
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. Data from an independent study of 96 eyes was presented as a poster at American Academy of Ophthalmology meeting in Chicago.
“Age-related macular degeneration is a progressive disease, with a significant unmet clinical need and no cure,” Dr. Scott Robbie, lead author and Chief Scientific Officer, LEH Pharma, said in a company news release. “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.
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.
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.