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Opus Genetics Partner Files Supplemental NDA for Presbyopia Drug

Story Highlights
  • On December 17, 2025, Viatris filed an FDA sNDA for Phentolamine to treat presbyopia.
  • The sNDA relies on positive VEGA-3 Phase 3 results, but FDA acceptance and review remain uncertain.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Opus Genetics Partner Files Supplemental NDA for Presbyopia Drug

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Opus Genetics ( (IRD) ) has shared an update.

On December 17, 2025, Viatris Inc., the commercialization partner for Phentolamine Ophthalmic Solution 0.75% (Phentolamine), filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval of Phentolamine as a treatment for presbyopia. The submission, backed by positive efficacy, safety, and durability data from the VEGA-3 Phase 3 trial that confirmed earlier VEGA-2 results, marks a key regulatory step that could expand Phentolamine’s commercial prospects in the presbyopia market, though there remains uncertainty over if and when the FDA will accept and review the application.

The most recent analyst rating on (IRD) stock is a Buy with a $9.00 price target. To see the full list of analyst forecasts on Opus Genetics stock, see the IRD Stock Forecast page.

Spark’s Take on IRD Stock

According to Spark, TipRanks’ AI Analyst, IRD is a Neutral.

Opus Genetics faces significant financial challenges, with declining revenues and persistent losses undermining its financial stability. The technical indicators suggest a bearish trend, while the negative corporate event further highlights financing difficulties. These factors contribute to a low overall score, indicating a high-risk investment with uncertain prospects.

To see Spark’s full report on IRD stock, click here.

More about Opus Genetics

Average Trading Volume: 527,114

Technical Sentiment Signal: Buy

Current Market Cap: $139.3M

See more data about IRD stock on TipRanks’ Stock Analysis page.

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