Phentolamine: Presbyopia Trial Success – Phase 3 Data
- Opus Genetics reported that phentolamine ophthalmic solution 0.75% met its primary and key secondary endpoints in a second phase 3 clinical trial for the treatment of presbyopia.
- According to Opus Genetics CEO, George Magrath, MD, many patients want a noninvasive presbyopia treatment that does not affect distance vision or nighttime visual function.He told Healio that...
- The VEGA-3 trial was a multicenter, randomized, double-masked, placebo-controlled study.
Opus Genetics‘ phentolamine ophthalmic solution 0.75% achieved key endpoints in a Phase 3 trial for presbyopia, offering a potential noninvasive treatment. Results demonstrate significant betterment in near visual acuity, a crucial advancement for patients. The VEGA-3 trial revealed that 27.2% of participants using phentolamine achieved the primary endpoint, considerably exceeding the placebo group. The positive safety profile aligns with prior studies, according to company reports. The CEO highlights the positive impact on patient-reported outcomes and satisfaction. News Directory 3 is closely following this breaking story as the company prepares for FDA submission in late 2025. Discover what’s next as researchers unlock further benefits.
Opus Genetics’ Phentolamine Shows Promise in Presbyopia Trial
Opus Genetics reported that phentolamine ophthalmic solution 0.75% met its primary and key secondary endpoints in a second phase 3 clinical trial for the treatment of presbyopia.
Key Points:
- The safety profile aligned wiht previous studies.
- Opus Genetics plans to submit to the FDA later in 2025.
Editor’s Note: This is a developing story and will be updated.
According to Opus Genetics CEO, George Magrath, MD, many patients want a noninvasive presbyopia treatment that does not affect distance vision or nighttime visual function.He told Healio that the VEGA-3 results were encouraging. The phentolamine ophthalmic solution 0.75% showed rapid and sustained betterment in near visual acuity without impacting distance vision.
The VEGA-3 trial was a multicenter, randomized, double-masked, placebo-controlled study. It assessed the safety and efficacy of phentolamine in 545 participants. Participants were randomly assigned to receive once-daily phentolamine or a placebo. The primary endpoint measured the proportion of participants achieving at least a 15-letter improvement in binocular distance corrected near visual acuity (DCNVA) with less than a five-letter loss in best corrected distance visual acuity from baseline at 12 hours post-dose on day 8, compared to placebo.
The company reported that 27.2% of participants receiving phentolamine achieved the primary endpoint, compared to 11.5% in the placebo group (P < .0001).Furthermore, 20.6% of the phentolamine group showed a 15-letter or greater improvement in DCNVA at 1 hour post-dose on day 1, versus 6.1% of the placebo group (P = .0002).
Magrath highlighted the strength of patient-reported outcomes, particularly improvements in near vision and satisfaction upon awakening (P < .0001 for both).
Magrath added that the safety profile was consistent with previous studies, with no serious treatment-related adverse events. Common, mainly mild, adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia.
Magrath noted that these findings reinforce the potential of phentolamine’s sympatholytic mechanism, which does not engage the ciliary muscle, resulting in a low headache prevalence of 2.6%. Opus Genetics aims to submit to the FDA in the second half of 2025.