Phentolamine Ophthalmic Solution 0.75%

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Opus Genetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-03 20:30
Core Insights - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases and small molecule therapies for other ophthalmic disorders [1][3] - The company granted equity awards to two new non-executive employees as an inducement for employment, consisting of stock options and restricted stock units (RSUs) [1][2] Equity Awards Details - The equity awards include stock options for 240,000 shares and 150,000 RSUs, with the stock options having an exercise price of $0.94, equal to the closing price on the grant date [2] - Stock options vest over four years, with 25% vesting on the one-year anniversary and the remaining 75% vesting quarterly thereafter; RSUs vest in four equal installments on each anniversary of the grant date [2] Company Pipeline - Opus Genetics is developing AAV-based gene therapies targeting inherited retinal diseases such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [3] - The lead candidate, OPGx-LCA5, is in a Phase 1/2 trial for LCA5-related mutations and has shown promising early results [3] - Additional programs include OPGx-BEST1 for BEST1-related retinal degeneration and a Phase 3-ready small molecule therapy for diabetic retinopathy, developed under a Special Protocol Assessment with the FDA [3] - The company is also advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and is being studied in two Phase 3 programs for presbyopia and dim light vision disturbances [3]
Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia
Prnewswire· 2025-06-26 10:55
Core Insights - Viatris Inc. announced positive top-line results from the VEGA-3 Phase 3 trial for MR-141, demonstrating significant improvement in near visual acuity for patients with presbyopia without compromising distance vision [1][2] - The trial involved 545 patients and showed that MR-141 significantly outperformed placebo in achieving primary and secondary endpoints [5][6] - The company plans to submit an application to the U.S. FDA in the second half of 2025 [1][8] Company Overview - Viatris is a global healthcare company that combines generics and brand medications to address healthcare needs, supplying high-quality medicines to approximately 1 billion patients annually [7] - The company is headquartered in the U.S. with global centers in Pittsburgh, Shanghai, and Hyderabad [7] Industry Context - Presbyopia affects nearly 128 million people in the U.S., approximately 90% of adults over 45, and is projected to impact 2.1 billion people globally by 2030 [6] - The condition leads to significant economic losses, estimated between $11 billion and $25 billion due to uncorrected cases, highlighting the need for effective near-vision correction solutions [6]
Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Globenewswire· 2025-06-26 10:55
Study met its primary and key secondary endpoints, demonstrating rapid and sustained improvement in near visual acuitySafety profile consistent with previous clinical trials and no treatment-related serious adverse events reported in the studyNo evidence of tachyphylaxis was observed in this study over the 6-week periodManagement to Host Webcast and Conference Call Today at 8:00 A.M. ET RESEARCH TRIANGLE PARK, N.C., June 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopha ...
Opus Genetics Announces LYNX-2 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients with Visual Disturbances Under Mesopic, Low-Contrast Conditions
GlobeNewswire· 2025-06-02 12:00
Study met primary endpoint of ≥15-letter (≥3-line) gain in mesopic low contrast distance visual acuity in comparison to placeboPhase 3 study showed patient-reported functional benefit in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision, a condition with no current FDA-approved therapiesSafety profile consistent with previous studies, with no new safety signals identified No evidence of tachyphylaxis was observed in this study over the 6-week per ...
Opus Genetics Announces Financial Results for First Quarter 2025 and Provides Corporate Update
GlobeNewswire News Room· 2025-05-15 12:00
ARVO presentation highlights 12-month results from Phase 1/2 study that support potential of OPGx-LCA5 gene therapy to restore meaningful vision Pediatric cohort of LCA5 study ongoing with initial multi-patient data anticipated in Q3 2025 OPGx-BEST1 on track for IND filing and initiation of Phase 1/2 trial with early data expected in Q1 2026 Leading healthcare investors provide funding to deliver on key milestones RESEARCH TRIANGLE PARK, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IR ...
Opus Genetics Announces Presentations on Inherited Retinal Disease Programs at Medical Conferences in May
Globenewswire· 2025-05-12 12:00
RESEARCH TRIANGLE PARK, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders, today announced presentations related to its IRD gene therapy programs at these upcoming scientific conferences in May. Presentation Details American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting Title:Evaluation of MERTK gene therapy ...
PRISM MarketView Spotlights Opus Genetics in New Q&A with CEO George Magrath
Newsfilter· 2025-04-15 14:36
NEW YORK, April 15, 2025 (GLOBE NEWSWIRE) -- PRISM MarketView today published a Q&A feature with Dr. George Magrath, Chief Executive Officer of Opus Genetics, Inc. ("Opus Genetics" or the "Company") (NASDAQ:IRD), a clinical-stage gene therapy company developing treatments for inherited retinal diseases (IRDs) and broader ophthalmic conditions. Dr. George Magrath, Chief Executive Officer of Opus Genetics, Inc. In the interview, Dr. Magrath outlines Opus Genetics' recent milestones, including: Completion of ...
Opus Genetics Announces Financial Results for Full Year 2024
Newsfilter· 2025-03-31 12:20
Provides update on the Company's transformation and promising portfolio of innovative gene therapy treatments for inherited retinal diseases Strong cash position with $21.5 million financing to supplement $30.3 million year-end balance New capital supports delivery on key milestones for two lead gene therapy candidates OPGx-LCA5 and OPGx- BEST1 RESEARCH TRIANGLE PARK, N.C., March 31, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. ("Opus" or the "Company") (NASDAQ:IRD), a clinical-stage ophthalmic biopharmaceu ...
Opus Genetics Announces Presentation on Phentolamine Ophthalmic Solution 0.75% in Dim Light Disturbances at World Cornea Congress IX
Globenewswire· 2025-03-21 13:30
RESEARCH TRIANGLE PARK, N.C., March 21, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies for other ophthalmic disorders, today announced that a presentation featuring the LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% in patients with dim light disturbances will be delivered this week at World Cornea Congress IX, taking place March 20-22, ...