UK regulators warn of ocular side effects after treatment with Sanofi's Dupixent

After five years of Dupixent’s reign for Sanofi, the U.K.'s medicines regulatory agency is warning about the risks of ocular side effects.

In a Tuesday update from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), officials noted risks of ocular reactions that are usually mild but can become serious if "not managed properly." 

The regulator asked patients and healthcare providers to look out for sudden changes in vision or eye pain after treatment. Patients are asked to “promptly report” new or worsening symptoms.

Meanwhile, the agency says it's working on new guidance for management of patients with Dupixent-related ocular complications.

Known adverse reactions to Dupixent include conjunctivitis and allergic conjunctivitis, eye itching, swollen eye, and dry eye. While most side effects are mild, some can worsen with improper management. The regulatory agency has received a “small number” of reports of ulcerative keratitis with serious corneal damage associated with Dupixent treatment.

The concern led the agency to review the risks, and it's now seeking advice from specialists. MHRA is also recommending that Dupixent’s product information be updated to include dry eye as an adverse drug reaction. 

Through early September, the agency received 479 reports of ocular side effects after Dupixent treatment, with 111 considered serious. That latter figure includes five cases of ulcerative keratitis, two cases of corneal perforation, and 18 reports of side effects in children 6 to 17 years of age. 

"Patient safety is of utmost importance to Sanofi and Regeneron," a Sanofi spokesperson said in an emailed statement to Fierce Pharma. "Based on ongoing review, available data do not suggest a new safety concern related to ocular findings in patients receiving dupilumab," the spokesperson added, noting that patients should "promptly report" new onset or worsening eye symptoms to their healthcare provider. 

Dupixent has long been Sanofi and Regeneron’s crown jewel. Sales of the drug grew to $2.3 billion in this year’s third quarter. Sanofi earlier this year raised its peak sales target to at least 13 billion euros, hoping to target at least 1.5 million more eligible patients worldwide by 2025 through new label expansions.

Dupixent is already on a roll with new indications, just this year being cleared for prurigo nodularis, eosinophilic esophagitis, and pediatric atopic dermatitis.