Dexycu: China’s First Single-Injection Cataract Drug via Lecheng RWD

I still remember the first time I watched a patient struggle with postoperative eye drops. She was a 78-year-old grandmother from a small town in Guangdong, recovering from cataract surgery. The procedure itself had gone beautifully — the phacoemulsification was smooth, the intraocular lens was perfectly placed. But when I gave her the standard postoperative instructions: four different eye drops, four times a day, for four weeks — her face fell. “Doctor,” she said, “my hands shake. My grandson has to help me with the drops, but he goes to school during the day. I don’t think I can do this.”

I tried to reassure her, but I knew she was right. The data on postoperative compliance among elderly cataract patients is sobering. Multiple studies have shown that adherence to complex eye drop regimens drops sharply after the first week, and by the second week, many patients are missing doses entirely. The consequences can be serious: untreated postoperative inflammation can lead to pain, delayed visual recovery, cystoid macular edema, and even permanent vision loss. And yet, we were asking elderly patients — many with arthritis, tremor, or cognitive decline — to perform a task that required steady hands, good eyesight, and impeccable memory, four times a day, every day, for a month.

That grandmother’s struggle has stayed with me for years. But this week, I finally have a better answer to offer.

On July 1, 2026, China’s National Medical Products Administration (NMPA) officially approved the marketing of dexamethasone intraocular suspension (OT-502), under the brand name Dexycu, for the treatment of postoperative inflammation following cataract surgery. This is not just another drug approval — it represents a fundamental rethinking of how we manage inflammation after one of the most common surgical procedures in the world.

Dexycu is a novel, biodegradable, single-injection sustained-release anti-inflammatory drug. Here is how it works: at the very end of cataract surgery, the surgeon administers a single 0.005 mL dose of Dexycu directly into the posterior chamber of the eye, behind the iris. The active ingredient — dexamethasone, a potent corticosteroid — begins working immediately and continues to release steadily for 21 to 22 days. The delivery system is based on Verisome® technology, a proprietary platform that enables sustained, controlled drug release without the need for the patient to do anything at all. The formulation is biodegradable and does not require removal.

What does this mean for patients? It means that instead of managing a complex, month-long regimen of eye drops, patients receive their entire postoperative anti-inflammatory treatment in a single injection at the end of surgery. No drops to remember. No shaking hands struggling with tiny bottles. No missed doses. No confusing schedules. The surgeon takes care of it, and the patient simply heals.

Dexycu was first approved by the U.S. Food and Drug Administration in February 2018, making it the first and only FDA-approved single-dose sustained-release intraocular steroid for postoperative inflammation. In January 2020, Ocumension Therapeutics — a Chinese ophthalmic pharmaceutical company — secured the exclusive rights to develop and commercialize OT-502 in China. In April 2024, the product completed its Phase III clinical trial in China, demonstrating that the proportion of subjects achieving anterior chamber cell grade 0 on day 8 was significantly higher than in the placebo group, confirming both safety and efficacy.

For the millions of cataract patients in China — and there are many, given that the prevalence of cataracts among people aged 60 to 89 is approximately 80%, and exceeds 90% among those aged 90 and above — Dexycu offers something that has been sorely lacking: simplicity.

But how did Dexycu reach Chinese patients so quickly? The answer lies in a remarkable policy innovation called the Boao Lecheng Real-World Data (RWD) Pilot.

Real-world data, in simple terms, refers to health-related information collected outside of traditional clinical trial settings — from electronic health records, patient registries, insurance claims, and — crucially — from routine clinical practice. When these data are rigorously collected, standardized, and analyzed, they become real-world evidence (RWE), which can be used to support regulatory decisions about the safety and efficacy of medical products.

The Boao Lecheng International Medical Tourism Pilot Zone — China’s only national-level “medical special zone” — was established by the State Council with a clear mission: to become a hub for international medical tourism, cutting-edge research, and the convergence of advanced medical technologies. In 2019, the National Medical Products Administration, in collaboration with the Hainan provincial government, launched the Clinical Real-World Data Application Pilot in Lecheng. This made Lecheng the first region in China authorized to use real-world clinical data to support the registration and approval of innovative pharmaceuticals and medical devices.

Here is how it works. Under Lecheng’s “first-pilot, first-use” policy, innovative drugs and devices that have already been approved by major international regulators — such as the U.S. FDA or the European Medicines Agency — can be made available to patients within the Lecheng Pilot Zone on a limited, controlled basis. As these products are used in real clinical practice, data are systematically collected through Lecheng’s specialized RWD platform. These data are then analyzed and, if they meet rigorous quality standards, can be submitted to the NMPA as supplementary evidence to support the product’s formal registration for the broader Chinese market.

The results have been nothing short of transformative. Since the pilot began, 27 international innovative pharmaceuticals and medical devices have been approved for market entry in China through this pathway. In 2026 alone, five products have already been approved using Lecheng real-world data. More than 580特许 pharmaceuticals, devices, and specialty foods have achieved their “China-first use” in Lecheng. Over 30 medical institutions are now operational within the zone, and the number of medical tourists has grown substantially.

The policy has also shown its value beyond just speeding up approvals. Four products have used Lecheng RWD to gain inclusion in China’s national drug reimbursement list. The province has issued a Clinical Real-World Data Application Pilot 2025–2027 Three-Year Action Plan, establishing a robust monitoring and coordination mechanism. And just this year, Hainan was selected as the only healthcare-sector recipient of the national “Industry Trusted Data Space” pilot — a recognition of the region’s leadership in making healthcare data “suppliable, flowable, and usable”.

Dexycu’s journey to Chinese patients is a textbook example of how this policy works in practice.

Long before the product received formal NMPA approval, Ocumension Therapeutics had already secured approval to make Dexycu available in Lecheng as a clinically urgently needed medical device. The first patient in China received Dexycu at a Lecheng hospital during this early access phase. In August 2021, OT-502 was officially included in the Lecheng Real-World Data Application Pilot program. The company then conducted a prospective, real-world study in Hainan, collecting data from 113 subjects who received Dexycu and 150 subjects in an external control group. The study evaluated efficacy and safety in real-world clinical settings — not in the controlled, artificial environment of a clinical trial, but in the actual conditions under which patients receive care.

These real-world data, combined with the rigorous Phase III clinical trial results, provided the NMPA with a comprehensive evidence package. The result? On July 1, 2026 — just a few years after the RWD pilot began — Dexycu received full marketing authorization in China. The approval came with a National Drug Approval Number: 国药准字HJ20260066.

What would this timeline have looked like without the Lecheng RWD pathway? Traditionally, bringing a new drug from overseas approval to Chinese market entry can take five years or more, requiring a full suite of domestic clinical trials conducted from scratch. The Lecheng pathway compressed that timeline dramatically. By allowing early clinical use, collecting real-world evidence, and providing regulatory agencies with high-quality data from actual clinical practice, the system enabled Dexycu to reach patients years earlier than it otherwise would have.

I think back to that grandmother from Guangdong. If she were having cataract surgery today, in a Lecheng-affiliated hospital, her experience would be fundamentally different. At the end of her procedure, her surgeon would administer a single injection of Dexycu. She would go home that same day. She would not need to worry about remembering which drop goes first, or whether she had already taken her morning dose. She would not need to ask her grandson to come home during school hours to help her with the drops. The medicine would already be there, working quietly in the background, releasing precisely the right amount of dexamethasone over the next three weeks.

Her recovery would be simpler. Her stress would be lower. And her risk of complications from missed doses would be all but eliminated.

That is the promise of Dexycu. And that is the promise of the Lecheng Real-World Data pathway — a system that brings the world’s best medical innovations to Chinese patients faster, more safely, and more efficiently than ever before.

But this is just the beginning. The Lecheng RWD pilot is still evolving. The Three-Year Action Plan is now in effect. The NMPA and the Hainan provincial government are deepening their collaboration. More products are entering the pipeline every month. And every day, more patients are gaining access to therapies that, just a few years ago, would have been out of reach for years — or forever.