Lexitas Pharma Services' CMO discusses groundbreaking ophthalmology conference, emphasizing innovative clinical trials, emerging treatments for eye diseases, and the potential for transformative patient care strategies.
David Tanzer, MD, Lexitas Pharma Services' CMO, met up with Modern Retina® to chat during the 2025 Retina World Congress annual meeting.
"This has been an amazing conference, and congratulations to the organizers and all the speakers who've learned so much – durable treatments for the bread-and-butter type of indications we heard yesterday about great treatments for geographic atrophy, including what are novel endpoints that are relevant to patients and regulators and payers," Tanzer said. "You know, from an anatomic and a functional perspective, we heard a little bit about inherited retinal diseases, cell and gene therapy, and really exciting space to be in right now."
He reflected on Dr. William Boyd, the FDA's current center director for the CDER ophthalmology head, introduced a paradigm-shifting perspective on clinical trial design, suggesting that pivotal studies no longer need to follow traditional parallel confirmatory models. Instead, researchers can now explore modified clinical trial designs that potentially broaden efficacy and safety endpoints, which could lead to more comprehensive treatment labels.
Lexitas is "a full service contract or clinical research organization," Tanzer said. "We're based in Durham, and we've been in this industry fully focused on ophthalmology for 14 years. I've actually only been the CMO for the last 2 months. I've been in ophthalmology for 30 years, but proud to represent Lexitas as their Chief Medical Officer, and really bring our knowledge, skills, abilities and partnership to sponsors, either strategics or small biotech companies emerging into this novel and dynamic space of ophthalmology, both in the posterior and anterior segment, both in devices and pharma. We're honored to partner with with companies looking to bring novel treatment options for for patients who who need something to be new and proved and different, to help with their their various diseases."
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