EyePoint, Inc

Regeneron Pharmaceuticals announced that the US FDA approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification lesions and flare-ups in adults with fibrodysplasia ossificans progressiva, based on positive Phase 3 OPTIMA trial results. The approval adds a rare-disease monoclonal antibody to Regeneron's portfolio, reinforcing the company's focus on specialized, high-complexity immunology therapies. The Pasatru FOP approval supports the rare-disease angle, but its ultra-rare scope does not materially change the key near term story, which still centers on defending ophthalmology revenues and proving that pipeline investments can support margins as competition and pricing pressures build. The news fits alongside recent ophthalmology updates and the failed non-inferiority readout for EyePoint's Duravyu versus EYLEA in wet AMD, which helps frame the competitive backdrop. Regeneron's narrative projects $19.4 billion revenue and $6.0 billion earnings by 2029, with a fair value estimate of $833.31.

EyePoint Pharmaceuticals announced that its investigational wet age-related macular degeneration treatment Duravyu failed to meet the primary endpoint of non-inferiority on best corrected visual acuity versus Regeneron's Eylea in the first of two pivotal phase III studies, sending its shares down 67% on Monday. The LUGANO study enrolled 211 patients and was affected by an asymmetric cohort of nine patients, about 4% of the group, who experienced vision loss of at least 15 letters that EyePoint said was unrelated to wet AMD, while no Eylea patients had similar vision loss. An ad hoc analysis excluding those nine patients showed Duravyu was non-inferior to Eylea, and the candidate achieved a 42% reduction in treatment burden, meeting the threshold for superiority. Duravyu also demonstrated favorable durability, with 54% of patients remaining supplement-free through week 56, and safety was comparable to Eylea with no cases of insert migration or severe intraocular inflammation. EyePoint expects top-line results from the identical LUCIA study in the fourth quarter of 2026 and anticipates potentially submitting a new drug application in the first half of 2027, pending those results.

EyePoint Pharmaceuticals agreed to pay $4.6 million to resolve allegations that it paid kickbacks to certain healthcare providers to boost sales of its eyecare product Dexycu. The U.S. Department of Justice announced the settlement on Friday, stating that EyePoint paid kickbacks to certain Ambulatory Service Centers between 2019 and 2023, inducing them to purchase Dexycu in violation of the False Claims Act. The allegations involve excessive free Dexycu samples provided to the centers and an Assurance Program that reimbursed or compensated them if payors denied coverage or under-reimbursed for the drug. Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division emphasized that kickbacks by pharmaceutical companies increase drug costs for patients and federal health care programs, and that the division will hold accountable anyone who pays unlawful kickbacks. EyePoint did not immediately respond to a request for comment.