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FDA approves Opus Genetics' eye drop RYZUMVI for presbyopia

Fri, 16 Oct 2026 12:00:28 -0400

Opus Genetics, Inc. (Nasdaq: IRD) announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for phentolamine ophthalmic solution 0.75%, marketed as RYZUMVI, for the treatment of presbyopia in adults.

Presbyopia is an age-related condition that reduces the ability to focus on nearby objects. According to the company, the condition affects approximately 90% of adults in the United States over the age of 45. The approval expands RYZUMVI's existing indication, which covers pharmacologically induced mydriasis in adults and pediatric patients aged three and older.

The FDA decision was supported by results from the Phase 3 VEGA-2 and

Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia

Fri, 16 Oct 2026 12:00:00 -0400

FDA expands the approved use of phentolamine ophthalmic solution 0.75% to include age-related near vision impairment, which affects millions of adults in the United States

Approval supported by positive results from pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary efficacy endpoints

RESEARCH TRIANGLE PARK, N.C., Oct. 16, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the

Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia

Fri, 16 Oct 2026 12:00:00 -0400

FDA expands the approved use of phentolamine ophthalmic solution 0.75% to include age-related near vision impairment, which affects millions of adults in the United States

Approval supported by positive results from pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary efficacy endpoints

Opus Genetics (IRD) Reiterated at Market Outperform by Citizens on Key Learnings from BEST1 Cohort

Fri, 16 Oct 2026 04:52:13 -0400

Citizens analyst Jonathan Wolleben reiterated a Market Outperform rating and $17.00 price target on Opus Genetics (NASDAQ: IRD).

The analyst commented, "Opus has generated some key learnings out of its first cohort of BEST1 patients that it is applying to Cohort 2, which we think, along with higher dosing, could show an improved treatment benefit. We are cautiously optimistic though as 75% of evaluable patients in Cohort 1 met the proposed pivotal microperimetry endpoint, and it will be hard to top that mark (see our coverage here). Thus, the new learnings, along with the longitudinal data from Cohort 1, may provide

Form 8-K Opus Genetics, Inc. For: Oct 14

Thu, 15 Oct 2026 17:23:00 -0400

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Opus Genetics reports gene therapy trial data for two eye diseases

Thu, 15 Oct 2026 16:00:30 -0400

Opus Genetics, Inc. (Nasdaq: IRD) presented clinical data from its OPGx-BEST1 and OPGx-LCA5 gene therapy programs at the Retina in Rio 2026 conference in Rio de Janeiro, Brazil, on Oct. 15, 2026.

In the Phase 1/2 BIRD-1 trial of OPGx-BEST1, three of four evaluable participants in the low-dose Cohort 1 showed improved retinal sensitivity in the treated transitional zone, representing 75% of that group. Follow-up ranged from three to six months across five total participants. The company said additional analyses identified retinal structural and imaging characteristics that may help predict treatment response. Enrollment in the high-dose Cohort 2, comprising 11 participants,

Opus Genetics reports gene therapy trial data for two eye diseases

Thu, 15 Oct 2026 16:00:30 -0400

Opus Genetics, Inc. (Nasdaq: IRD) presented clinical data from its OPGx-BEST1 and OPGx-LCA5 gene therapy programs at the Retina in Rio 2026 conference in Rio de Janeiro, Brazil, on Oct. 15, 2026.

Opus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026

Thu, 15 Oct 2026 16:00:00 -0400

OPGx-BEST1 showed improved retinal sensitivity in 75% of evaluable participants in the initial low-dose Cohort 1 of the Company’s Phase 1/2 clinical trial, supporting further clinical development

New BEST1 data analyses link retinal structure to visual function, enabling focus on regions most likely to respond to treatment

OPGx-LCA5 demonstrated sustained improvements in visual acuity and light sensitivity through 24 months in adults, with encouraging results in pediatric participants through six months in the Company’s Phase 1/2/3 clinical trial

Phase 3 clinical trial dosing for OPGx-LCA5 expected in the fourth quarter of 2026

Opus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026

Thu, 15 Oct 2026 16:00:00 -0400

OPGx-BEST1 showed improved retinal sensitivity in 75% of evaluable participants in the initial low-dose Cohort 1 of the Company’s Phase 1/2 clinical trial, supporting further clinical development

New BEST1 data analyses link retinal structure to visual function, enabling focus on regions most likely to respond to treatment

Phase 3 clinical trial dosing for OPGx-LCA5 expected in the fourth quarter of 2026

Opus Genetics to Present at the Chardan Annual Healthcare Conference

Tue, 13 Oct 2026 07:00:00 -0400

RESEARCH TRIANGLE PARK, N.C., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), announced today that management will present at the Chardan Annual Healthcare Conference on Tuesday, October 20, 2026 at 10:00 a.m. ET.

A link to the live and archived webcast may be accessed on Opus Genetics’ website under the Investors section: Events.

About Opus Genetics

Opus Genetics is

Opus Genetics to Present at the Chardan Annual Healthcare Conference

Tue, 13 Oct 2026 07:00:00 -0400

A link to the live and archived webcast may be accessed on Opus Genetics’ website under the Investors section: Events.

About Opus Genetics

Opus Genetics is

Form 4 Opus Genetics, Inc. For: Sep 30 Filed by: Foundation Fighting Blindness Retinal Degeneration Fund

Fri, 02 Oct 2026 19:47:00 -0400

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Form 4 Opus Genetics, Inc. For: Sep 09 Filed by: Magrath George

Fri, 11 Sep 2026 16:10:00 -0400

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Form 8-K Opus Genetics, Inc. For: Sep 11

Fri, 11 Sep 2026 07:48:00 -0400

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Big Pharma Setbacks Create a New Wave of Rebound Plays