FDA Approves Opus Genetics’ Phentolamine Solution for Presbyopia

FDA approves adult presbyopia indication

The U.S. Food and Drug Administration has approved Opus Genetics’ phentolamine ophthalmic solution 0.75% for the treatment of age-related presbyopia in adults, according to Visionmonday.

Visionmonday reported that the FDA decision expands the indication for phentolamine ophthalmic solution 0.75%. The approval concerns age-related presbyopia in adults.

Opus Genetics, Inc. announced the approval from Research Triangle Park, N.C., Visionmonday reported. The company is described by Visionmonday as a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases.

Product’s reported U.S. use

Before the reported indication expansion, the product had been marketed in the United States as RYZUMVI for the treatment of pharmacologically induced mydriasis, according to Visionmonday.

The FDA approval now adds treatment of age-related presbyopia in adults to the product’s reported U.S. indication. Visionmonday characterized the action as an expansion of the product’s indication.

For medical sales professionals following ophthalmic products, the event is an FDA approval involving a product already marketed in the United States under the RYZUMVI name. The reported development centers on phentolamine ophthalmic solution 0.75% and its adult presbyopia indication.

Key details reported by Visionmonday

• Company: Opus Genetics, Inc.
• Product: Phentolamine ophthalmic solution 0.75%
• FDA action: Approval
• Approved treatment: Age-related presbyopia in adults
• Reported U.S. brand: RYZUMVI
• Previously reported U.S. use: Treatment of pharmacologically induced mydriasis

What the announcement establishes

Visionmonday’s report establishes that the FDA approved phentolamine ophthalmic solution 0.75% for age-related presbyopia in adults and that the action expands the product’s indication. It also notes the product’s prior U.S. marketing as RYZUMVI for pharmacologically induced mydriasis.

The report identifies Opus Genetics as the company behind the announcement and describes its gene-therapy development focus in inherited retinal diseases. The FDA action itself concerns the ophthalmic solution and adult age-related presbyopia.