27 EyeWorld Asia-Pacific | June 2025 CORNEA happens in the central cornea, there’s a signal to heal, and the cells march their way across the cornea. They leave the niche, they lose their supportive protein microenvironment, and they start to differentiate, and hopefully grow back over the entire surface. If those cells had a scaffold that retained regenerative potential, it would support their expansion across the ocular surface,” Dr. Tauber said. “The original development concept was to use that membrane, grow a layer of cells on it, and provide surgeons with both membrane and cells,” he said. “That is a more challenging regulatory pathway for FDA approval that’s on our radar. … But it turned out that the decellularized Descemet’s membrane is highly effective even on its own.” Rajan Shukla, CEO of Brightstar Therapeutics, has worked in front-of-the-eye therapeutics since 2014 and has previously worked with serum tears. It was this work and his interest in novel therapies for severe dry eye and ocular surface disease that ultimately led him to BrightMEM. “When you look at quality of life, severe dry eye disease is comparable to hip fracture and severe angina in that it impedes patients from living their lives. In many cases, patients can suffer from both significant vision loss and constant eye pain,” he said. BrightMEM helps fill a niche designed for these severe ocular surface disease patients who have impaired healing of their cornea. “All of the limbal stem cells, all of the cells in the eye that produce the clear cornea [epithelium], live in a specialized area called the limbal niche, which is in a ring around the cornea,” Mr. Shukla said. “These cells produce the corneal epithelium, and when the cornea is damaged or the epithelium is removed, the limbal stem cells migrate out of the niche and start repopulating the cornea, but once they leave that niche, they lose their stem cell phenotype. What that means is that stem cells are capable of self-renewing so they can do horizontal division, making another stem cell, or they can differentiate into mature epithelial cells, which form the clear cornea. Once they exit the niche, however, they lose their stem cell phenotype.” That’s when you start to see… conjunctiva growing over [the cornea], and that ends up causing pain and photophobia. So patients are in a terrible condition where they can’t see and they’re in pain all the time.” The company was looking for a new membrane that was both durable and optically clear, so it could replicate the limbal niche and maintain the stem cells long term. Mr. Shukla said BrightMEM is designed to be a long-term solution for patients. It’s designed to take advantage of Descemet’s membrane’s resistance to degradation despite compromise of other parts of the cornea. The other major discovery, he said, is that this membrane has proteins that are found in the limbal niche but not found in the central cornea. These proteins enable it to mimic the niche environment, ideally keeping stem cells alive long term. He said laboratory data has demonstrated this, and it has been compared to amniotic membrane. “You can grow limbal stem cells on BrightMEM, and they form a stratified layer of cornea, with layers of mature epithelium, just like the normal eye would, but the very bottom layer still expresses the markers for limbal stem cells, so we’re creating this reservoir on the ocular surface of stem cells,” Mr. Shukla said. For patients with persistent epithelial defects, there is an overwhelmed stem cell population and a sick ocular surface because the limbal stem cells can’t keep up with maintaining the clear epithelium. Mr. Shukla mentioned a pilot clinical study in humans that, to date, has had 14 completed cases. In that study, patients with congenital aniridia, a genetic disorder of the eye associated with limbal stem cell deficiency, were enrolled for treatment. Fifty-seven percent of patients had neovascularization in the central cornea degrading their vision. All patients underwent transplantation of a BrightMEM allograft. The intention was to evaluate whether BrightMEM could augment the remaining limbal stem cell population on the ocular surface in these patients, prevent neovascularization, and rehabilitate vision long term. Interim 6-month results were promising, with all patients healed and no recurrence of central neovascularization. In addition, all of the patients who were candidates wanted to have their second eye done. Mr. Shukla also discussed how the product could be used for ocular pain, as it has the potential to provide immediate pain relief from postop day 1. This insight arose when BrightMEM was given to a patient who had ocular toxicity associated with a new cancer drug for end-stage cervical cancer. The pain from the ocular toxicity was debilitating, and with limited options, the surgeon used BrightMEM. Within days after the procedure in her first eye, the pain was completely gone. The surgeon soon treated the second eye in the same way with similar results. According to Dr. Cheung, the BrightMEM procedure initially involves a keratectomy where irregular epithelium and anterior corneal scarring is removed from the cornea to
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