Eyeworld

82 | EYEWORLD | SPRING 2026 C ORNEA Relevant disclosures Chamberlain: ReGenTree site investigator Galor: Alcon, Bausch + Lomb, Dompé, Oculis Pflugfelder: None In addition to cenegermin, the cornea subspecialty has a long history of using biologics such as serum tears, platelet-enriched plasma, and amniotic membrane. Dr. Pflugfelder also mentioned insulin drops for epithelial defects, neurotrophic keratitis, and dry eye. The success other medical specialties have had with biologics has ophthalmology looking for additional options. Thymosin β-4 Thymosin β-4, which is being developed by RegeneRx Biopharmaceuticals and its partner ReGenTree as RGN-259 eye drops, Dr. Chamber- lain said, is following a similar path to ceneg- ermin in that it's being studied as a treatment for NK, but it drives a different cellular sig- nal—a signal for cell migration. "Breakdown of epithelial layers on the ocular surface or a break in intracellular adhesion molecules can lead to geographic defects or small, microscopic fissures on the surface that promote inflammation. Thymosin β-4 has the potential to drive migra- tion across denuded areas and cause these cells to integrate with each other, which will drive healing on the surface," he explained. Addition- al applications for the ocular surface could be targeted with thymosin β-4 as well. RGN-259 has completed one Phase 3 clinical trial for neurotrophic keratopathy and is conducting ad- ditional Phase 3 clinical trials for this indication. It has also investigated the drop for moderate to severe dry eye disease. Anti-TNFα Dr. Galor talked about topical anti-TNFα being developed as licaminlimab by Oculis for treat- ment of dry eye and potentially uveitis. "What they have found is that there is a genetic polymorphism in the TNF1 receptor that predicts whether you're going to respond better to this biologic," she said. "It doesn't mean that if you don't have this polymorphism, you won't respond. But instead of saying, 'We're going to go after the entire pie of dry eye,' they're saying … 'We're going to try to help you identify the people who may need our product.'" Dr. Galor said, at least at present, ophthal- mology isn't quite geared toward this level of precision medicine, but she hopes it's trending in that direction. "Oncology is showing us what is possible. Now with these bioinformatics and AI, it should be possible to do a better job in drug selection," she said. Oculis has completed Phase 2 clinical trials with licaminlimab and is expected to begin a registrational trial. IL-1 receptor antagonists IL-1 receptor antagonists have been researched for corneal conditions like dry eye and allergic conjunctivitis but haven't gotten much momen- tum, Dr. Chamberlain thinks, in part due to limited trial designs. Dr. Chamberlain explained that IL-1 is an early mediator of inflammation, so blocking it can have beneficial downstream effects. "In my mind, that's a true target for a bio- logic," he said. "IL-1 receptor antagonists act on an upstream protein to block an early signal in inflammation." Lacripep "Lacripep, a first-in-class topical therapy based on the lacritin protein, being developed by Tear Solutions, is a trophic peptide that seems to drive survival, proliferation, and wound healing actions of epithelial cells," Dr. Chamberlain said. It is being investigated for Sjögren's dry eye and more generalized, moderate to severe dry eye. Epithelial and endothelial cell therapies Cell therapies for corneal conditions, such as en- dothelial disease and epithelial disorders, have caused excitement in recent years. Allogenic continued from page 80 Contact Chamberlain: wdchamberlain@gmail.com Galor: AGalor@med.miami.edu Pflugfelder: stevenp@bcm.edu continued on page 84 " There is a long list of biologics that are used for non-ocular conditions that may be useful for ocular conditions, and we just don't know because we don't use them that often." —Anat Galor, MD

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