Nanoscope Therapeutics Reveals Five-Year Safety Outcomes of MCO-010 Optogenetic Therapy for Retinitis Pigmentosa
In a significant milestone for ocular therapies, Nanoscope Therapeutics Inc. recently reported encouraging long-term safety findings from its EXTEND study, which examined the effects of MCO-010, an optogenetic therapy aimed at restoring vision in patients suffering from advanced retinitis pigmentosa (RP). This follows a previous Phase 1/2a trial where participants had received a single intravitreal injection of MCO-010. The EXTEND study, now marking five years of follow-up, highlights the treatment’s safety and tolerability.
According to the study, ten participants who previously took part in the earlier trial exhibited a consistent safety profile over the five-year period. The results showed no serious adverse effects or new safety concerns. During this time, participants also reported improvements in their quality of life related to vision, demonstrating the therapy's ongoing benefits. Dr. Samarendra Mohanty, President and Chief Scientific Officer of Nanoscope Therapeutics, stated, “The absence of serious safety signals and strong participant retention underscore the potential of MCO-010 as a durable, non-invasive therapy for severe vision loss in RP patients.”
Phase 1/2a data revealed that participants who received a higher dose of MCO-010 made statistically significant advancements in their visual acuity after just one year. The five-year follow-up data indicated that these participants maintained stable or enhanced quality of life measures associated with vision, particularly benefiting their distance activities and independence. This long-term retention of efficacy underscores MCO-010's promise in treating severe vision loss caused by RP.
Presented at the 34th Annual Conference of the Vitreo Retinal Society held in India, these data are instrumental for the future of optogenetic therapies. Nanoscope is actively pursuing regulatory approval for MCO-010, having initiated a rolling submission for its Biologics License Application (BLA) with the FDA. If approved, MCO-010 could become a new standard of care for patients suffering from RP.
Additionally, Nanoscope Therapeutics is exploring MCO-010's potential for other degenerative retinal conditions, including Stargardt Disease (SD), and has received Fast Track and Orphan Drug designations from the FDA for both RP and SD. Furthermore, plans are underway to commence a Phase 2 program targeted at geographic atrophy (GA) by the end of 2025.
The EXTEND study findings not only affirm the safety profile of MCO-010 but also spotlight Nanoscope Therapeutics' dedication to advancing innovative treatment solutions for retinal degenerative diseases. As they continue to drive the frontiers of vision restoration technology, the implications of their research may pave the way for many individuals seeking relief from the debilitating effects of vision loss.
For more information about Nanoscope Therapeutics and their outlined programs, including insights into their future plans and ongoing trials, please visit their official webpage or follow their communications for updates.
According to the study, ten participants who previously took part in the earlier trial exhibited a consistent safety profile over the five-year period. The results showed no serious adverse effects or new safety concerns. During this time, participants also reported improvements in their quality of life related to vision, demonstrating the therapy's ongoing benefits. Dr. Samarendra Mohanty, President and Chief Scientific Officer of Nanoscope Therapeutics, stated, “The absence of serious safety signals and strong participant retention underscore the potential of MCO-010 as a durable, non-invasive therapy for severe vision loss in RP patients.”
Phase 1/2a data revealed that participants who received a higher dose of MCO-010 made statistically significant advancements in their visual acuity after just one year. The five-year follow-up data indicated that these participants maintained stable or enhanced quality of life measures associated with vision, particularly benefiting their distance activities and independence. This long-term retention of efficacy underscores MCO-010's promise in treating severe vision loss caused by RP.
Presented at the 34th Annual Conference of the Vitreo Retinal Society held in India, these data are instrumental for the future of optogenetic therapies. Nanoscope is actively pursuing regulatory approval for MCO-010, having initiated a rolling submission for its Biologics License Application (BLA) with the FDA. If approved, MCO-010 could become a new standard of care for patients suffering from RP.
Additionally, Nanoscope Therapeutics is exploring MCO-010's potential for other degenerative retinal conditions, including Stargardt Disease (SD), and has received Fast Track and Orphan Drug designations from the FDA for both RP and SD. Furthermore, plans are underway to commence a Phase 2 program targeted at geographic atrophy (GA) by the end of 2025.
The EXTEND study findings not only affirm the safety profile of MCO-010 but also spotlight Nanoscope Therapeutics' dedication to advancing innovative treatment solutions for retinal degenerative diseases. As they continue to drive the frontiers of vision restoration technology, the implications of their research may pave the way for many individuals seeking relief from the debilitating effects of vision loss.
For more information about Nanoscope Therapeutics and their outlined programs, including insights into their future plans and ongoing trials, please visit their official webpage or follow their communications for updates.
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