Endpoints for Neuroprotection in Glaucoma Trials

Join us for a cutting-edge webinar delving into innovative clinical approaches and endpoints for new glaucoma treatments. Today, intraocular pressure (IOP) lowering therapies are currently the only proven neuroprotective therapies for glaucoma. While IOP therapies and devices are highly prevalent in use, unfortunately even with these treatments up to one in four patients still experience blindness in at least one eye. With disease progression still often significant despite the application of these therapies, clearly, this is an area of opportunity for new therapeutic entries.  As companies explore new therapies to provide neuroprotection (preserving neuronal integrity) or even neuroenhancement (improving neuronal function), finding the right clinical approaches and endpoints to prove efficacy is of utmost importance.

This webinar, featuring leading glaucoma expert and Ora Chief Medical Officer, Dr. Gustavo De Moraes, highlights ground-breaking designs and endpoints for new glaucoma therapies that help better measure therapeutic impact and even demonstrate IOP-independent neuroprotection. Hear an overview of the latest research in this field, understand considerations for programs including currently stated FDA opinions, and dive deeply into recent studies that show the viability of these novel endpoints to demonstrate efficacy for new glaucoma potential therapies.

Ora Inc. is the only ophthalmic clinical trials company with a research and development (R&D) department focused on the evolution of clinical trials. As one of the top glaucoma experts in the world, Dr. De Moraes leads the Ora R&D team in exploring and developing new endpoints. He is excited to share with attendees the latest research shaping the future of glaucoma clinical trials, and to provide considerations for their therapeutic program to optimally capture the efficiency benefits for these challenging patients.

Speaker

Gustavo De Moraes, MD, PhD, MPH, Chief Medical Officer, Ora

Dr. Gustavo De Moraes, MD, PhD, MPH is Ora’s Chief Medical Officer and Associate Professor of Clinical Ophthalmology at the Department of Ophthalmology at Columbia University Medical Center, New York Presbyterian Hospital, in New York City, NY. He is a Clinician and Surgeon with expertise in glaucoma, anterior segment and general ophthalmology. He has published over 220 papers in top peer-reviewed journals and has served on the editorial boards of some of the journals with the highest impact factor in the field of Ophthalmology. He has authored or co-authored 11 book chapters in ophthalmology and glaucoma, as well as the Consensus on Medical Treatment and Consensus on Glaucoma Progression of the WGA. He has given over 200 guest lectures worldwide. Based on his research, Dr. De Moraes has been ranked among the top 10 glaucoma experts in the world.

At Ora, Dr. De Moraes leads the medical safety and pharmacovigilance team. He also assists sponsors with protocol design, optimizing recruitment and retention strategies, endpoint determination and discussions regarding regulatory pathways. Moreover, Dr. De Moraes supports Ora’s research & development team in developing new testing modalities that aim to help develop new endpoints for clinical trials, optimize signal-to-noise ratio and reduce sample size and study duration. Dr. De Moraes assists Ora’s network of study sites and investigators (“OraNet”) in identifying clinical sites, reviewing their capabilities and providing real-time feedback on study requirements, patient enrollment and retention.

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