In the News
OcuDyne Announces Positive Results for the OPTiC System™ 6-Month Clinical Trial in the Treatment of Geographic Atrophy
FOR IMMEDIATE RELEASE
Brooklyn Park, MN, September 9, 2024
OcuDyne, Inc, a medical device company employing a novel approach to the treatment of ocular disease, announced today successful completion of a pilot study using the proprietary OPTiC System in the treatment of Age-Related Macular Degeneration (AMD).
- Procedural feasibility of ophthalmic artery angioplasty in the treatment of vascular lesions associated with geographic atrophy has been demonstrated, with a positive safety profile.
- Secondary and exploratory endpoints associated with subjective and objective evidence of visual
function preservation at 6 months, has been demonstrated.
Interim data from this clinical trial were accepted and presented at the annual Association for Research in Vision and Ophthalmology (ARVO) meeting in Seattle, WA in May 2024. Final data is now available, is supporting a pivotal trial application in Argentina, and will be presented to the FDA as conversations with the Agency continue.
Safety
- All ocular adverse events with procedural causality were transient and resolved without treatment or sequalae.
- All systemic adverse events with procedural causality were expected potential events, treated, and resolved without sequalae.
- There were no device related adverse events reported.
Effectiveness
Subjective evidence of visual function improvement was demonstrated in Best-Corrected Visual Acuity, MNRead Acuity, Critical Print Size, and Reading Speed, as well as Patient Reported Outcomes associated with Mobility and Independence and Reading and Accessing Information.
Objective evidence of visual function preservation and increased choroidal perfusion were demonstrated in growth inhibition of geographic atrophy and postoperative increase in sub-foveal choroidal thickness, respectively.
“The completion of this trial is the culmination of a decade of focused scientific research into perfusion of the retina and how it affects macular function. We are very excited with the trial results and how these data support the OcuDyne hypothesis. Our next focus will be the development of additional data to support a pathway for regulatory approval.” Jeff Franco, CEO.
About Chronic Ischemic AMD and OcuDyne
The potential influence of a chronic ischemic environment secondary to atherosclerotic vascular disease in the ophthalmic artery, on the development of geographic atrophy in age-related macular degeneration, is beginning to be more widely recognized and understood. AMD is a complex disease that includes genetic, life style, and environmental influences. Ischemia has long been understood to cause hypoxia and hypoxia is known to be present in retinal atrophy. OcuDyne, Inc. is a clinical stage company dedicated to exploring the potential causative implications of cardiovascular disease on AMD and treating this disease with cardiovascular therapies.
Investor Relations Contact
Jeff Franco, CEO
jfranco@ocudyne.com
OPTiC System Final Data – Retina Forum 2024 in Barcelona
OcuDyne CEO, Jeff Franco will be presenting final clinical data from the Argentina OC-1901AR study in Barcelona, Spain. The ophthalmology futures forum is one of most anticipated annual meetings, bringing clinicians, scientists, regulators, and industry leaders together with the potential to shape the future of retinal disease management.
OPTiC System Interim Data at ARVO in Seattle
OcuDyne has been accepted to provide three poster presentations that include the interim data analysis of the Argentina OC-1901AR study at The Association for Research in Vision and Ophthalmology (ARVO) in Seattle, WA. This is the world’s largest research focused ophthalmology meeting and draws both physicians and industry participation from all over the world.
OC-1901AR Study Closes Enrollment
Enrollment is closed on the OC-1901AR study and the final subject will be treated in early February. Interim data will be available May 2024 and final data expected August 2024.
Argentina Study
Protocol OC-1901AR (Argentina arm of the original OC-1901 study) has received approval to proceed from the regulatory authority (ANMAT) and enrollment is open!
Clinical study details and site contacts can be located here: OC-1901AR Argentina | Clinicaltrials.gov Listing
OA Angioplasty in Tokyo
Dr. Ivan Lylyk of Buenos Aires, Argentina presented the compassionate use case series data associated with ophthalmic artery angioplasty in the treatment of late-stage AMD to physicians from around the world, attending the World Federation of Interventional and Therapeutic Neuroradiology meeting in Tokyo, Japan.
OA Angioplasty in Bogotá
Drs. Ivan Lylyk and Anibal Francone of Buenos Aires, Argentina presented their compassionate use case series data associated with ophthalmic artery angioplasty in the treatment of late-stage AMD. They brought their novel experiences to the physicians attending the Curso International de Oftalmologia (International Course of Ophthalmology) meeting in Bogata, Columbia where it was met with enthusiasm and lively discussion.
Retinal Deposits and Cardiovascular Disease
Robert Thompson and his colleagues at Mt. Sinai in NYC published their study evaluating the presence of subretinal drusenoid deposits (also known as reticular pseudo-drusen) and soft drusen, their two pathways to advanced AMD, associated genetic risk alleles, and underlying cardiovascular disease. These authors demonstrated that subretinal drusenoid deposits are associated with cardiovascular disease, stroke, lower HDL, and ARMS2 risk allele (well known to be associated with AMD). In addition, those with soft drusen were associated with higher HDL, CFH risk allele (also known to be associated with AMD), and two lipid risk genes. The data suggests that soft drusen and subretinal drusenoid deposits found in the retina, may well be markers for distinct disease.
ARVO Poster
Retinal specialist Philip J Rosenfeld, MD from Bascom Palmer Institute presented his poster at the annual meeting for The Association for Research in Vision and Ophthalmology (ARVO) in New Orleans, LA. These results are part of an ongoing prospective study demonstrating visual acuity in normal eyes, AMD eyes with drusen, and AMD eyes with non-foveal GA correlate with decreased perfusion (blood flow) of the choriocapillaris. Normal luminance VA (normal vision), low luminance VA (dim light vision), and the low luminance deficit (the difference between normal and dim light vision) all correlate with the choroidal choriocapillaris perfusion. This is an ongoing study which provides the missing link between decreased choriocapillaris perfusion and visual function.
Journal of NeuroInterventional Surgery
Drs. Lylyk and Lylyk from the ENERI medical institution in Buenos Aires are once again “In the News!” They have participated in an SNIS Insights online webinar for the Journal for NeuroInterventional Surgery (JNIS) Journal Club with renowned retinal specialist Philip J Rosenfeld, MD from the Bascom Palmer Eye Institute, to discuss ophthalmic artery angioplasty in the treatment of AMD. An interesting discussion ensued, providing insight from both Interventional Radiology and Ophthalmology perspectives.
This webinar followed presentations at top Interventional Neuroradiology medical conferences around the globe where Drs. Lylyk discussed the data associated with their compassionate use case series of patients.
- Semana Del Intervencionismo Mínimamente Invasivo (SIMI)
Buenos Aires, Argentina | December 2020 - Society of NeuroInterventional Surgery (SNIS)
Colorado Springs, Colorado USA | July 2021 - Brazilian Society of INR & Endovascular Surgery (SOBRICE)
São Paulo, Brazil | October 2021 - Brain Research and Advanced Interventional Neuroradiology (BRAIN)
London, United Kingdom | December 2021 - SNIS Insights: Online Webinar Series | JNIS Journal Club
Recorded | Thursday | March 3, 2022