IRDOpus Genetics, Inc.

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Opus Genetics completes dosing in gene therapy trial cohort - Investing.com

Investing.com · Nov 5, 12:42 PM

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Opus Genetics Completes Dosing in Cohort 2 of Phase 1/2 - GlobeNewswire

GlobeNewswire · Nov 5, 12:00 PM

Market reactionShares fell 10% on Nov 5.

IntactLast material event Oct 16, 2026 · Updated Oct 21, 2026

Presbyopia approval expands partnered opportunity; BEST1 remains the central clinical driver

Opus develops retinal gene therapies, led by BEST1 and LCA5, and partners phentolamine eye drops with Viatris. The drops are approved in the United States for pupil-dilation reversal and adult presbyopia.

Opus's case rests on BEST1's early visual gains translating into pivotal success, alongside LCA5 development and Viatris-partnered phentolamine. Presbyopia approval expands the partnered opportunity and triggers a milestone. BEST1 higher-dose results are expected in Q2 2027, with pivotal dosing planned for 2027. RDH12 IND clearance broadens development opportunities, with a Phase 1/2 trial planned this quarter and conditional partner reimbursement. Cash supports development, but debt obligations and future capital needs remain important.

Thesis checklist

0 risks need attention

Select a row for evidence
The higher-dose BEST1 cohort confirms the signalAwaiting evidenceNext: Higher-dose safety and functional results, alongside longer low-dose follow-up, expected in Q2 2027.

Why it is in this state

The evidence, what would weaken it and the source filing

The BEST1 pivotal trial startsAwaiting evidenceNext: First pivotal participants dosed, with final design and patient-reported outcome requirements disclosed.

Why it is in this state

The evidence, what would weaken it and the source filing

The small LCA5 trial supports approvalAwaiting evidenceNext: Registrational retinal sensitivity results and FDA feedback on whether they support approval.

Why it is in this state

The evidence, what would weaken it and the source filing

Phentolamine is approved for presbyopiaSupportedNext: Milestone payment details and Viatris's commercial rollout and uptake disclosures.

Why it is in this state

The evidence, what would weaken it and the source filing

Next decision point

Can higher-dose BEST1 repeat the early visual gains?

Tests: The higher-dose BEST1 cohort confirms the signal

Q2 2027: three-month higher-dose and six-month low-dose data expected.

Do higher-dose BEST1 results show consistent visual improvements and favorable safety with prespecified, imaging-guided retinal locations?

Strong, inconclusive and weak outcomes

What to look for in the result and how each would move the checklist

Questions to investigate

History

Price and material events

Select an event marker to read the update below. Marker colors show Thesis status.

IntactCurrentRegulatory
-5.2%Oct 16, 2026

Presbyopia approval expands partnered opportunity; BEST1 remains the central clinical driver

IntactClinical
+32.0%Sep 9, 2026

BEST1 progress remains central; financing supports development but adds obligations

About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.

Pipeline

BEST1-related retinal degeneration· Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB)
OPGx-BEST1 · 4 upcoming · 2 completed
Phase 1/2 Data: ToplineBIRD-1Pivotal
Q1 2027
Phase 3 commercial manufacturing requirements completion
early 2027
Phase 1/2 Data: ToplineBIRD-1Pivotal
Q2 2027
Phase 3 Study Initiation
H2 2027
RDH12-related Leber congenital amaurosis (LCA)· inherited retinal degeneration
OPGx-RDH12 · 1 upcoming
Phase 1/2 Study Initiation
Q4 2026
MERTK-related retinal degeneration· inherited retinal disease
OPGx-MERTK · 1 upcoming
Study InitiationEU
Q1 2027
Leber congenital amaurosis type 5 (LCA5)· inherited retinal degeneration
OPGx-LCA5 · 1 upcoming · 3 completed
Phase 3 Data: Topline
End of 2027
Retinitis pigmentosa· autosomal dominant RHO mutations
OPGx-RHO · 1 upcoming
Study Initiation
H2 2027
Presbyopia
Phentolamine Ophthalmic Solution · 2 completed
PDUFA Decision
Reported Oct 16, 2026
sNDA Submission
Dec 17, 2025

Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.

Quick answers

Is the Opus Genetics (IRD) investment thesis intact?
Yes. Readouts currently rates the Opus Genetics Thesis Intact. Presbyopia approval expands partnered opportunity; BEST1 remains the central clinical driver.
What is the next catalyst for Opus Genetics (IRD)?
The next dated event is Phase 1/2 start for OPGx-RDH12, expected Q4 2026, as stated by the company. Also ahead: Trial start for OPGx-MERTK, expected Q1 2027.
How long will Opus Genetics' cash last?
Opus Genetics has said its cash will fund operations into 2029 (guidance as of September 11, 2026).

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Drug pages: Phentolamine ophthalmic solution 0.75%
Disease areas: Eye diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes

Competitive landscape

6 peers tracked

For informational purposes only—not investment advice. Always conduct your own research before making investment decisions.

Financial snapshot

Dates and calculation details

Cash: Market-data provider estimate; measurement period unavailable.

Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.

Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.

Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.

Runway: No underlying guidance available.