Shares in EyePoint Pharmaceuticals more than tripled Monday morning after the Massachusetts-based biotechnology company announced summary results from a mid-stage study of an experimental eye disease drug it’s developing.
EyePoint’s medicine, called vorolanib, matched the performance of Regeneron’s top-selling drug Eylea in people with a form of age-related macular degeneration, EyePoint said. The Phase 2 trial was designed to compare vorolanib to Eylea on several measures, including its impact on visual acuity, and assess whether the latter medicine was “non-inferior” to Regeneron’s.
“Since EYP-1901 achieved statistical non-inferiority to the [Eylea] control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” said Jay Duker, EyePoint’s CEO, using the medicine’s code name in a Monday statement.
The company plans to discuss its Phase 3 plans with the Food and Drug Administration, and start its first pivotal trial in the “wet” form of age-related macular degeneration, or AMD, in the second half of next year.
EyePoint shares rose by as much as 232% early Monday morning, before settling back to trade up 176%. The stock jump added several hundreds of millions of dollars to the company’s market valuation, now over $600 million.
The study enrolled 160 people with wet AMD who were previously treated with standard therapies and randomized them to receive either one of two EYP-1901 doses, or Eylea. EyePoint’s drug was given via a single intravitreal injection in a doctor’s office.
Along with meeting the study’s main endpoint on visual acuity, EYP-1901 wasn’t associated with any ocular or systemic adverse events. Four percent of patients discontinued the study through week 32, EyePoint said.
The company plans to present detailed data from the study at a medical meeting in February.
Eylea has long dominated the market for wet AMD treatment. But it has competition from a new Roche drug, Vabysmo, and will soon face low-cost biosimilar rivals. Regeneron is counting on a high-dose formulation of Eylea to counter those headwinds and, after a delay, secured FDA approval for that version in August.
EyePoint could be another competitor. But Brian Abrahams, an analyst at RBC Capital Markets, discounted the drug’s impact on Regeneron and Eylea, noting how EyePoint’s trial was “stacked for success” and that some of the reported benefit may be due to residual effects from prior treatment.
“While we remain more cautious on the overall landscape for Eylea, we do not see 1901 as being nearly as important a threat as Roche, biosimilar Eylea, and the [Inflation Reduction Act],” Abrahams wrote in a client note Monday.