HLB wraps phase 3 dosing for eye drop rival to Oxervate, touts simpler dosing and lower price tag

A single 56-day treatment course costs more than $110,000. The prep involves disinfectant wipes, adapters, pipettes, and a 13-step ritual to get one drop into the eye. That’s the reality for patients prescribed Oxervate (cenegermin), the only FDA-approved drug for neurotrophic keratitis (NK), a rare degenerative eye disease.

HLB Therapeutics is betting it can simplify all of that—and potentially undercut the price tag that comes with it.

The Korean biotech announced Thursday that it has completed dosing and two-week follow-up in a European phase 3 trial (SEER-3) of its NK candidate RGN-259, developed through its U.S. subsidiary ReGenTree. Seventy-eight patients were treated across 25 hospitals in Spain, Italy, Poland, and Germany, with the trial wrapping four months ahead of schedule. HLB said it has begun the final data review and will move quickly to lock the data for statistical analysis.

RGN-259 is taken five times daily, with two drops per dose. Each single-use vial contains enough for a single application and is discarded immediately—even if the solution remains. That format, the company says, offers a major edge over Italian drugmaker Dompé’s Oxervate, which relies on multi-dose vials that require daily assembly of a pipette and adapter, along with sterile cleaning steps before each use.

“Compared to Oxervate’s 13-step daily routine, our single-use format makes RGN-259 much more patient-friendly,” an HLB spokesperson told Korea Biomedical Review.

While Oxervate’s label lists eye pain in 16 percent of patients, additional side effects such as corneal deposits, inflammation, and tearing are also reported. HLB, meanwhile, said its drug showed no meaningful differences from placebo in safety or tolerability across its studies.

RGN-259 is based on thymosin beta-4, a naturally occurring peptide. The company said the compound is quickly broken down in the body and is unlikely to trigger immune reactions or long-term accumulation.

While Oxervate runs about $118,230 for a full 56-day course, HLB told Korea Biomedical Review it applied a 30 percent discount—pricing its product at roughly $80,000—when estimating RGN-259’s potential value. That said, the figure was used for internal modeling only, the company spokesperson noted, and pricing has not been finalized with topline data still pending.

Meanwhile, Dompé has dominated the NK market since Oxervate’s 2018 approval, with a per-vial list price of $2,111.25 helping drive U.S. revenue past $800 million in 2023, according to industry estimates. The company did not respond to a request for comment about HLB’s clinical progress or the prospect of competition.

HLB is also looking to accelerate patient enrollment in its U.S. phase 3 trial (SEER-2), after receiving clearance to expand the study into Europe. Regenerx Biopharmaceuticals has estimated RGN-259’s market potential at between $800 million and $2.2 billion, “assuming success of the two phase 3 NK trials and potential market dominance expected upon approval of RGN-259.”

“If the high efficacy we anticipate is confirmed, we expect to rapidly move forward with licensing negotiations,” HLB Therapeutics CEO Ahn Ki-hong said in a statement.