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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
Core Insights - Opus Genetics, Inc. is presenting results from the LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% at the World Cornea Congress IX, focusing on its potential to treat dim light disturbances in patients, particularly those who have undergone keratorefractive surgery [1][3][4] Study Results - The LYNX-1 Phase 3 study met its primary endpoint, showing that 13% of participants treated with Phentolamine gained 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8 compared to 3% in the placebo group (p<0.05) [5] - At Day 15, 21% of Phentolamine-treated participants gained 15 or more letters of mLCVA compared to 3% in the placebo group (p<0.01) [5] - Patient-reported outcomes for glare, halos, and starbursts were significantly lower in the Phentolamine group at Day 15 (p<0.01) [5] - In a subset analysis of post-LASIK participants, 29% of those treated with Phentolamine gained 15 or more letters of mLCVA at Day 8 compared to 9% in the placebo group [5] - The positive results from the LYNX-1 study support the ongoing Phase 3 LYNX-2 trial, with topline results expected in mid-2025 [5] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on developing gene therapies for inherited retinal diseases and other ophthalmic disorders [4] - The company's pipeline includes AAV-based investigational gene therapies targeting mutations in genes associated with various retinal diseases, with the most advanced program addressing mutations in the LCA5 gene [4] - Phentolamine Ophthalmic Solution 0.75% is being investigated for its ability to reduce pupil size and improve vision in patients with reduced mesopic vision following keratorefractive surgery [6]
Opus Genetics Announces Pricing of Public Offering and Concurrent Private Placement with Proceeds of Over $20 Million
Globenewswire· 2025-03-21 13:11
Core Viewpoint - Opus Genetics, Inc. has announced a public offering and private placement to raise approximately $21 million for its gene therapy programs targeting inherited retinal diseases [1][3][4]. Group 1: Offering Details - The public offering consists of 21,052,631 shares of common stock and warrants at a price of $0.95, potentially generating gross proceeds of $20 million [5]. - The concurrent private placement includes 1,176,471 shares of common stock and warrants at an offering price of $1.275, with gross proceeds of $1.5 million [6]. - The total potential gross proceeds from both offerings, including warrants, could reach approximately $43 million [4]. Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized to fund clinical development of the lead gene therapy programs, OPGx-LCA5 and OPGx-BEST1, as well as for general corporate purposes and working capital [3]. Group 3: Warrants and Conditions - Warrants issued in the public offering could provide up to $21.4 million in additional capital upon the release of OPGx-BEST1 DUO-1001 Cohort 1 data [4]. - The warrants from the public offering will be exercisable immediately and have an initial exercise price of $0.95, expiring five years from issuance [5]. - The private placement warrants will also be exercisable immediately, with an initial exercise price of $1.15, and similar expiration terms [6]. Group 4: Company Background - Opus Genetics is focused on developing gene therapies for inherited retinal diseases and other ophthalmic disorders, with a pipeline that includes investigational therapies for various genetic mutations [11]. - The company is currently evaluating its most advanced gene therapy program in a Phase 1/2 trial, with plans to initiate a Phase 1/2 study for BEST1 in 2025 [11].
Opus Genetics Announces Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting
Globenewswire· 2025-03-05 13:00
Core Insights - Opus Genetics, Inc. announced that three abstracts on its investigational gene therapy candidates have been accepted for presentation at the ARVO 2025 Meeting, showcasing 12-month data from the first three adult patients in the ongoing Phase 1/2 trial of OPGx-LCA5 [1][3] - The company aims to advance OPGx-LCA5 into a pivotal Phase 3 trial, contingent on continued safety and efficacy results [3] Group 1: OPGx-LCA5 Trial Results - The ongoing Phase 1/2 trial of OPGx-LCA5 has shown that subjective and objective signs of efficacy persisted for one year in the first three adult patients [1][4] - Previous results indicated that OPGx-LCA5 was well tolerated, with all three adult patients demonstrating visual improvement at six months [4] Group 2: Upcoming Presentations - The abstracts accepted for presentation include details on OPGx-LCA5, OPGx-MERTK, and OPGx-RDH12, with specific presentation times and authors listed [2][4][5] - A subset analysis from the completed LYNX-1 Phase 3 trial of Phentolamine Ophthalmic Solution 0.75% will also be presented, focusing on reduced mesopic low contrast vision in post-LASIK subjects [6] Group 3: Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on developing gene therapies for inherited retinal diseases and other ophthalmic disorders [7] - The company's pipeline includes several investigational gene therapies targeting various genetic mutations associated with retinal diseases, with OPGx-LCA5 being the most advanced candidate [7]