Viatris: Ocuphire trial results posted, Amnesteem label update, gabapentin abuse study completed
Viatris-linked news includes posted Phase 3 results for a post-refractive surgery eye drop, an approved Amnesteem labeling supplement, and a completed gabapentin abuse-potential study.
Three Viatris-related regulatory and trial items surfaced in the week of August 21, 2026.
- FDA approved a labeling supplement for Mylan Pharms' generic isotretinoin capsule Amnesteem (ANDA075945, submission 54), covering 10mg, 20mg, 30mg, and 40mg oral capsule strengths, with a standard review priority.1
- Results were posted for the Phase 3 "LYNX-2" trial (NCT06349759) of 0.75% phentolamine ophthalmic solution, sponsored by Ocuphire Pharma with Viatris as a collaborator. The study evaluated whether the solution could improve mesopic low contrast visual acuity in patients with post-refractive surgery visual disturbances2, and enrolled 200 participants2, with the primary outcome measuring the percentage of subjects achieving at least a 15-letter (3-line) improvement in mesopic low contrast visual acuity at Day 15 compared to baseline.2
- A Phase 4 Viatris-sponsored crossover study (NCT07777965) evaluating the abuse potential of oral gabapentin was completed. The trial compared two gabapentin doses against placebo and alprazolam in healthy, non-drug-dependent participants with sedative drug use experience3, and enrolled 44 participants.3
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.