Opus Genetics Announces Presentation on Phentolamine Ophthalmic Solution 0.75% in Dim Light Disturbances at World Cornea Congress IX
Opus Genetics (Nasdaq: IRD) has presented positive results from its LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% at World Cornea Congress IX. The study demonstrated significant improvements in patients with dim light disturbances:
The trial met its primary endpoint with 13% of treated patients gaining 15+ letters of mesopic low contrast distance visual acuity (mLCVA) versus 3% for placebo at Day 8. Results improved at Day 15, with 21% of treated patients showing gains versus 3% for placebo.
Notably, post-LASIK participants showed strong results, with 29% gaining improved mLCVA at Day 8 compared to 9% for placebo. The treatment also significantly reduced patient-reported glare, halos, and starbursts. The ongoing LYNX-2 Phase 3 trial is fully enrolled with results expected mid-2025.
Opus Genetics (Nasdaq: IRD) ha presentato risultati positivi dal suo studio di Fase 3 LYNX-1 riguardante la soluzione oftalmica di fenotolamina allo 0,75% al World Cornea Congress IX. Lo studio ha dimostrato significativi miglioramenti nei pazienti con disturbi in condizioni di scarsa illuminazione:
La sperimentazione ha raggiunto il suo obiettivo primario con il 13% dei pazienti trattati che ha guadagnato più di 15 lettere di acuità visiva a distanza in condizioni di contrasto basso mesopico (mLCVA) rispetto al 3% del gruppo placebo al Giorno 8. I risultati sono migliorati al Giorno 15, con il 21% dei pazienti trattati che ha mostrato guadagni rispetto al 3% del placebo.
In particolare, i partecipanti post-LASIK hanno mostrato risultati notevoli, con il 29% che ha guadagnato un miglioramento dell'mLCVA al Giorno 8 rispetto al 9% per il placebo. Il trattamento ha anche ridotto significativamente il fenomeno del riverbero, degli aloni e delle esplosioni di luce riportati dai pazienti. La sperimentazione LYNX-2 di Fase 3 è attualmente completamente arruolata, con risultati attesi per la metà del 2025.
Opus Genetics (Nasdaq: IRD) ha presentado resultados positivos de su estudio de Fase 3 LYNX-1 sobre solución oftálmica de fenotolamina al 0,75% en el World Cornea Congress IX. El estudio demostró mejoras significativas en pacientes con alteraciones en condiciones de poca luz:
El ensayo cumplió su objetivo primario, con el 13% de los pacientes tratados que ganaron más de 15 letras de agudeza visual a distancia en condiciones de bajo contraste mesópico (mLCVA) en comparación con el 3% del placebo en el Día 8. Los resultados mejoraron en el Día 15, con el 21% de los pacientes tratados mostrando ganancias frente al 3% del placebo.
Notablemente, los participantes post-LASIK mostraron resultados sólidos, con el 29% que ganó una mejora en el mLCVA en el Día 8 en comparación con el 9% del placebo. El tratamiento también redujo significativamente los reportes de deslumbramiento, halos y estallidos de luz. El ensayo LYNX-2 de Fase 3 está completamente inscrito, con resultados esperados para mediados de 2025.
Opus Genetics (Nasdaq: IRD)는 World Cornea Congress IX에서 0.75% 펜토라민 안과 용액에 대한 LYNX-1 3상 연구의 긍정적인 결과를 발표했습니다. 이 연구는 어두운 조명에서의 장애가 있는 환자들에게 상당한 개선을 보여주었습니다:
시험은 주요 목표를 달성했으며, 치료를 받은 환자의 13%가 8일 차에 플라시보의 3%에 비해 15자 이상의 mesopic 저대비 거리 시각적 선명도(mLCVA)를 얻었습니다. 결과는 15일 차에 개선되어, 치료를 받은 환자의 21%가 플라시보의 3%에 비해 향상을 보였습니다.
특히, LASIK 수술 후 참가자들은 8일 차에 29%가 mLCVA 개선을 보였으며, 이는 플라시보의 9%와 비교됩니다. 이 치료는 또한 환자가 보고한 눈부심, 후광, 별빛 현상을 상당히 줄였습니다. 진행 중인 LYNX-2 3상 시험은 완전히 등록되었으며, 결과는 2025년 중반에 예상됩니다.
Opus Genetics (Nasdaq: IRD) a présenté des résultats positifs de son étude de Phase 3 LYNX-1 sur la solution ophtalmique de phentolamine à 0,75% lors du World Cornea Congress IX. L'étude a démontré des améliorations significatives chez les patients présentant des troubles en faible luminosité :
L'essai a atteint son objectif principal avec 13% des patients traités gagnant plus de 15 lettres d'acuité visuelle à distance en conditions de faible contraste mesopique (mLCVA) contre 3% pour le placebo au Jour 8. Les résultats se sont améliorés au Jour 15, avec 21% des patients traités montrant des gains contre 3% pour le placebo.
Notamment, les participants post-LASIK ont montré des résultats solides, avec 29% ayant gagné une amélioration de l'mLCVA au Jour 8 par rapport à 9% pour le placebo. Le traitement a également réduit de manière significative les éblouissements, halos et éclats de lumière rapportés par les patients. L'essai LYNX-2 de Phase 3 est entièrement inscrit, avec des résultats attendus pour la mi-2025.
Opus Genetics (Nasdaq: IRD) hat positive Ergebnisse aus seiner LYNX-1 Phase-3-Studie zur 0,75% Phenotolamin-Augentropfenlösung beim World Cornea Congress IX präsentiert. Die Studie zeigte signifikante Verbesserungen bei Patienten mit Störungen bei schwachem Licht:
Die Studie erreichte ihr primäres Ziel, wobei 13% der behandelten Patienten am Tag 8 mehr als 15 Buchstaben an mesopischer Sehschärfe (mLCVA) im Vergleich zu 3% für das Placebo gewannen. Die Ergebnisse verbesserten sich am Tag 15, wobei 21% der behandelten Patienten im Vergleich zu 3% für das Placebo Gewinne zeigten.
Besonders bemerkenswert war, dass die Teilnehmer nach LASIK starke Ergebnisse zeigten, wobei 29% am Tag 8 eine Verbesserung der mLCVA im Vergleich zu 9% für das Placebo erzielten. Die Behandlung reduzierte auch signifikant die von den Patienten berichteten Blendung, Halos und Lichtblitze. Die laufende LYNX-2 Phase-3-Studie ist vollständig eingeschrieben, und Ergebnisse werden für Mitte 2025 erwartet.
- Phase 3 LYNX-1 trial met primary endpoint with statistically significant results
- Treatment efficacy increased from Day 8 (13%) to Day 15 (21%)
- Strong results in post-LASIK subset (29% improvement vs 9% placebo)
- Significant reduction in glare, halos, and starbursts symptoms
- LYNX-2 Phase 3 trial fully enrolled, results expected mid-2025
- Treatment effectiveness to 21% of overall patients at Day 15
- Post-LASIK efficacy decreased from 29% at Day 8 to 21% at Day 15
Insights
Opus Genetics has achieved a significant clinical milestone with its Phentolamine Ophthalmic Solution 0.75% Phase 3 LYNX-1 trial, demonstrating statistically significant improvements in mesopic low contrast distance visual acuity (mLCVA) for patients with dim light disturbances. The primary endpoint was met with
Most compelling is the subset analysis of post-LASIK patients, where treatment effects were particularly pronounced –
Patient-reported outcomes showing significant reductions in glare, halos, and starbursts further validate the real-world benefit of this therapy. The fully enrolled LYNX-2 Phase 3 trial, with topline results expected mid-2025, provides a clear development timeline and pathway to potential commercialization.
If approved, this would represent the first treatment specifically addressing visual disturbances in post-keratorefractive surgery patients – a condition linked to increased risk of motor vehicle accidents and diminished quality of life. This clear clinical progress positions Opus to potentially address a specialized but significant ophthalmic market segment currently lacking therapeutic options.
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
Key highlights from the presentation
- As previously reported, the LYNX-1 Phase 3 study met its primary endpoint, with a statistically significant greater percentage of Phentolamine Ophthalmic Solution
0.75% -treated participants gaining 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8, compared to placebo (13% vs.3% ; p<0.05). - The effect of Phentolamine Ophthalmic Solution
0.75% increased at Day 15, with21% of participants gaining 15 or more letters of mLCVA compared to3% of participants given the placebo (p<0.01). - Patient reported outcomes for glare, halos, and starbursts were significantly lower for the Phentolamine Ophthalmic Solution
0.75% group compared to placebo at Day 15 (p<0.01). - A subset analysis of post-LASIK participants demonstrated clinically meaningful results at Day 8, with
29% of Phentolamine Ophthalmic Solution0.75% participants gaining 15 or more letters of mLCVA compared to9% of participants given the placebo. - The effect of Phentolamine Ophthalmic Solution
0.75% was sustained at Day 15 in post-LASIK participants, with21% of participants gaining 15 or more letters of mLCVA compared to0% of participants given the placebo. - The positive LYNX-1 Phase 3 data support the rational of the ongoing Phase 3 LYNX-2 trial of Phentolamine Ophthalmic Solution
0.75% for keratorefractive patients with reduced mLCVA with photic phenomena. LYNX-2 is fully enrolled, with topline results expected mid 2025. - The full abstract can be accessed at the World Cornea Congress IX website here.
“We are pleased to present the results from the LYNX-1 Phase 3 trial of Phentolamine Ophthalmic Solution
| Presentation details | ||
| Title: | Randomized, Placebo-Controlled, Double-Masked Phase 3 Studies of Phentolamine Solution in Keratorefractive Patients with Dim Light Disturbances and Decreased Mesopic Vision | |
| Presenter: | Jay Pepose, M.D., Ph.D. (Chief Medical Advisor, Opus Genetics) | |
| Session: | Paper Session 2 | |
| Date/time: | Friday, March 21, 2025 at 2:10 – 2:16 PM ET | |
| Location: | Rock Creek C, Ballroom Level, Westin Washington DC Downtown | |
About Opus Genetics
Opus Genetics is a clinical-stage ophthalmic biotechnology company developing gene therapies to treat patients with inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders. The pipeline includes adeno-associated virus (AAV)-based investigational gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. Our most advanced investigational gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. BEST1 investigational gene therapy is designed to address mutations in the BEST1 gene, which is associated with retinal degeneration; we expect that a Phase 1/2 study will be initiated in 2025. The pipeline also includes Phentolamine Ophthalmic Solution
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Contacts
| Corporate | Investor Relations |
| Nirav Jhaveri CFO ir@opusgtx.com | Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com |
FAQ
What were the key results of Opus Genetics' LYNX-1 Phase 3 trial for Phentolamine Ophthalmic Solution?
How effective was IRD's Phentolamine treatment specifically for post-LASIK patients?
When will Opus Genetics (IRD) release results for the LYNX-2 Phase 3 trial?
What symptoms does Opus Genetics' Phentolamine Ophthalmic Solution 0.75% target?
