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Opus Genetics Secures FDA Approval for RYZUMVI to Treat Presbyopia

BullishMedium impact
IRD$3.95 −2.47%

Opus Genetics, Inc. (IRD) has received approval from the U.S. Food and Drug Administration for its supplemental drug application for RYZUMVI, an eye drop solution containing phentolamine ophthalmic solution 0.75%, to treat adult presbyopia. The decision allows the company to expand the label for RYZUMVI, which is already sold to treat mydriasis.

The regulatory clearance triggers an upfront milestone payment to Opus Genetics under its U.S. commercial partnership with Viatris, which holds the rights to commercialize the drug domestically. The approval was supported by Phase 3 data from the VEGA-2 and VEGA-3 clinical trials, where the drug met its key performance goals with no treatment-related serious adverse events reported.

Investors will be tracking upcoming details regarding the financial size of the milestone payout, as well as launch timing, pricing, and initial prescription adoption metrics overseen by Viatris. Despite the positive regulatory update, shares of Opus Genetics were trading down 4.57% at $3.865.

Key points

  • The FDA approved Opus Genetics' supplemental New Drug Application for RYZUMVI to treat adult presbyopia.
  • The regulatory approval triggers a milestone cash payment to Opus Genetics under its U.S. agreement with Viatris.
  • Approval was backed by successful Phase 3 results from the VEGA-2 and VEGA-3 trials with no treatment-related serious adverse events.
  • Opus Genetics shares fell 4.57% to $3.865 following the announcement.

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Questions and answers

What did the FDA approve for Opus Genetics?

The FDA approved Opus Genetics' supplemental New Drug Application for phentolamine ophthalmic solution 0.75% (RYZUMVI) to treat presbyopia in adult patients.

Who is commercializing RYZUMVI in the United States?

Viatris holds the U.S. commercialization rights for RYZUMVI under its deal with Opus Genetics.

What clinical trial data supported the FDA approval of RYZUMVI?

The clearance was supported by Phase 3 results from the VEGA-2 and VEGA-3 studies, which met efficacy endpoints without any treatment-related serious adverse events.