{"id":147488,"date":"2025-09-10T21:56:08","date_gmt":"2025-09-10T21:56:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/147488\/"},"modified":"2025-09-10T21:56:08","modified_gmt":"2025-09-10T21:56:08","slug":"opus-genetics-doses-first-patient-in-lynx-3-phentolamine-0-75-study","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/147488\/","title":{"rendered":"Opus Genetics doses first patient in LYNX-3 phentolamine 0.75% study"},"content":{"rendered":"

The first patient dosing is underway<\/a> for Opus Genetics, Inc.\u2019s third phase 3 clinical trial evaluating phentolamine ophthalmic solution (POS) 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision.<\/p>\n

Let\u2019s start with this ophthalmic solution.<\/p>\n

As we\u2019ve already routinely covered<\/a> POS 0.75% this past year<\/a>, here\u2019s a brief rundown:<\/p>\n

What it is: An antimicrobial, preservative-free (PF), topical solution formulated with the active ingredient: phentolamine (see here<\/a> for details on this).<\/p>\n

Check out<\/a> its mechanism of action, which involves pupil dilation.And its current indications?<\/p>\n

We\u2019ll start with its FDA-approved indication<\/a>\u2014under the name RYZUMVI\u2014for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents.<\/p>\n

Other investigational indications (via a globe license agreement with Viatris, Inc.) include:<\/p>\n

PresbyopiaReduced mesopic low contrast and night vision disturbances (NVDs) after keratorefractive surgery (our topic of discussion)Looking specifically at that last indication \u2026 how does POS 0.75% treat this?<\/p>\n

Per Opus Genetics: The eye drop is designed to<\/a> \u201cmoderately reduce pupil size in low-light conditions to potentially decrease the impact of aberrant peripheral light rays entering the pupil while maintaining retinal contrast sensitivity.\u201d<\/p>\n

The potential: To become the first FDA-approved therapeutic for patients experiencing NVDs.<\/p>\n

Now talk about this phase 3 trial.<\/p>\n

The LYNX-3 trial (NCT07140783<\/a>) is a multicenter, randomized, double-masked, placebo-controlled study being conducted under a Special Protocol Assessment (SPA) with the following setup:<\/p>\n

The participants: An estimated 200 patients (aged \u226518) with decreased visual acuity (VA) in mesopic conditions following keratorefractive surgery, including:Laser-assisted in situ keratomileusis (LASIK)Photorefractive keratectomy (PRK)Small-incision lenticule extraction (SMILE)Radial keratotomy (RK)The plan: Patients to be randomized 1:1 to receive once-daily evening doses of POS 0.75% or placebo for an estimated 2 weeksAnd what\u2019s being measured?<\/p>\n

The primary endpoint is the percentage of participants<\/a> achieving a \u226515-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (\u22653-line) improvement from baseline in mesopic low-contrast visual acuity (mLCVA) in the study eye at Day 15.<\/p>\n

Secondary endpoints include<\/a>:<\/p>\n

Patient-reported outcomes related to night driving, glare, halos, and starburstsBinocular visual function measuresSafety assessments (ocular and systemic evaluations)So when might data be available?<\/p>\n

Good question. The study is expected to conclude<\/a> in March 2026\u2014though interim data may be released earlier.<\/p>\n

Gotcha. In the meantime, any clinical evidence available yet for POS 0.75%?<\/p>\n

There is, as the LYNX-3 is actually the third phase 3 trial for this indication. The first was LYNX-1 (check out<\/a> its favorable safety and efficacy data) and the second was LYNX-2 (NCT06349759<\/a>).<\/p>\n

In fact, we just reported on positive topline data<\/a> from LYNX-2 this past June.<\/p>\n

The highlights version of those findings: The study met its primary endpoint<\/a> (at Day 15) and patient-reported outcomes indicated<\/a> “improvements in night-driving vision, enabling patients to function more effectively in low-light, low-contrast conditions.\u201d<\/p>\n

See here<\/a> for info on adverse events and POS 0.75%\u2019s safety profile.<\/p>\n

Sounds like promising data thus far.<\/p>\n

Indeed. And that\u2019s not including recent clinical findings<\/a> from the ongoing phase 3 VEGA-3 trial for POS 0.75%\u2019s presbyopia indication (which we covered in July 2025<\/a>).<\/p>\n

And what\u2019s the plan for a potential second regulatory submission?<\/p>\n

That\u2019s to be determined. Although, as we reported in July<\/a>, Opus Genetics did note an intent to use its phase 3 presbyopia data to support a new drug application (NDA) submission sometime in the second half (H2) of 2025.<\/p>\n

So stay tuned for updates on that \u2026<\/p>\n","protected":false},"excerpt":{"rendered":"The first patient dosing is underway for Opus Genetics, Inc.\u2019s third phase 3 clinical trial evaluating phentolamine ophthalmic…\n","protected":false},"author":2,"featured_media":147489,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[200,79],"class_list":["post-147488","post","type-post","status-publish","format-standard","has-post-thumbnail","category-genetics","tag-genetics","tag-science"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/147488","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=147488"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/147488\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/147489"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=147488"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=147488"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=147488"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}