FDA grants fast track designation to phentolamine ophthalmic solution 0.75%
Key takeaways:
- The designation is for the treatment of chronic night driving impairment after keratorefractive surgery.
- Enrollment is complete in the VEGA-3 phase 3 clinical trial of phentolamine for presbyopia.
The FDA granted fast track designation to phentolamine ophthalmic solution 0.75% to treat significant chronic night driving impairment in patients who have undergone keratorefractive surgery.
According to a press release from Opus Genetics, the designation will expedite the development and review of phentolamine in patients with reduced mesopic vision and photic phenomena.
“This designation offers Opus Genetics several key benefits, including more frequent interactions with the FDA, eligibility for priority review, as well as rolling review, allowing sections of the [new drug application] to be submitted and evaluated on an ongoing basis,” the release said.
Opus also announced that enrollment is complete in the VEGA-3 phase 3 clinical trial, which is investigating phentolamine for presbyopia treatment in 545 participants. Additionally, the company expects enrollment in the LYNX-2 pivotal phase 3 trial, which is investigating phentolamine for the treatment of visual loss in low light conditions associated with keratorefractive surgery, to conclude in the first half of the year.
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