A Phase 3 trial for an ophthalmic solution for treating patients with night vision disturbances is expected to begin soon.
There are currently no FDAapproved pharmacologic therapies to treat the condition, which can include glare, haloes, starbursts, and reduced contrast, which affect quality of vision, especially while driving at night.
Clinical-stage ophthalmic biopharmaceutical company Ocuphire Pharma said a special protocol agreement with the FDA “provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery”.
Ocuphire CEO Dr George Magrath anticipates patient enrolment in the LYNX-2 Phase 3 trial to evaluate phentolamine ophthalmic solution will begin early this year.1
The agreed primary endpoint of the LYNX-2 trial is a gain of three lines (or 15 letters) or more of distance vision improvement on a low contrast chart in dim light conditions after 15 days of dosing.
Ocuphire has a partnership with Viatris, Inc. to develop and commercialise phentolamine ophthalmic solution 0.75%. Phentolamine is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found on the iris dilator muscle without affecting the ciliary muscle. Unlike other miotics in the class it does not make the pupil too small, which can decrease contrast and degrade vision.
Reference
- Ocuphire Pharma, Ocuphire Pharma receives FDA agreement under special protocol assessment for LYNX-2 Phase 3 trial of phentolamine ophthalmic solution for the treatment of decreased visual acuity under dim (mesopic) light conditions (news release, 4 Jan 2024) available at: ocuphire. com/news-media/press-releases/detail/425/ ocuphire-pharma-receives-fda-agreementunder-special [accessed 20 Jan 2024].
