Ocuphire Pharma

Global Mydriasis treatment development involves 3+ key companies working on 3+ therapies, with clinical trials assessing safety, efficacy, and market impact. Key therapies include RYZUMVI, MYDCOMBI, and OMIDRIA. The market is driven by eye condition prevalence and technological advancements but faces barriers like high treatment costs and regulatory challenges.

The mydriasis market, with a 6.14% CAGR forecast for 2024-2034, is driven by eye disorders, surgical advancements, and imaging technologies. The U.S. leads in prevalence and treatment market. Recent developments include Ryzumvi's launch for pharmacologically-induced mydriasis management.

Focke Ziemssen, Michelle Sylvanowicz, Winfried M. Amoaku, Tariq Aslam, Bora Eldem, Robert P. Finger, Richard P. Gale, Laurent Kodjikian, Jean-François Korobelnik, Xiaofeng Lin, Anat Loewenstein, Paul Mitchell, Moira Murphy, David R. Owens, Nick Parker, Ian Pearce, Francisco J. Rodríguez, Jude Stern, S. James Talks, David T. Wong, Tien Yin Wong, and Jane Barratt disclose various financial interests including travel grants, personal fees, advisory board memberships, speaker fees, research sponsorship, and consulting roles with companies such as Allergan, AbbVie, Alimera, Bayer Healthcare, Biogen, Boehringer Ingelheim, Janssen, Novartis, Novo Nordisk, Merck, Regeneron, Roche, Sanofi, and others.

DelveInsight's 'Mydriasis Pipeline Insight, 2024' report details the global Mydriasis pipeline, featuring 3+ key companies developing 3+ therapies. Insights include clinical trials, mechanism of action, route of administration, and emerging therapies like RYZUMVI, MYDCOMBI, and OMIDRIA. The report covers pre-clinical to marketed phases, highlighting active and inactive projects, collaborations, and market dynamics.

Emerging therapies like LNZ100, Phentolamine Ophthalmic Solution 0.75%, and BRIMOCHOL PF are set to impact the presbyopia market (2024–2034). Presbyopia, an age-related condition affecting near vision, has ~325 million prevalent cases in 7MM, expected to grow at 1.1% CAGR. Treatments include corrective lenses, surgical procedures, and eye drops like VUITY and QLOSI. Market size is projected to reach ~USD 17 billion by 2034 with a 3.2% CAGR, driven by innovative therapies and rising incidence.

US FDA accepts NDA for LENZ Therapeutics' LNZ100 for presbyopia treatment, supported by Phase 3 CLARITY study data. Ocuphire Pharma acquires Opus Genetics, forming a key player in gene therapy for inherited retinal diseases. A study suggests 19% of dementia prevalence may result from correctable visual impairments. An optometrist shares experience in retina subspecialty. A new study finds higher glaucoma prevalence in the US than previously estimated.

Ocuphire Pharma acquired Opus Genetics in an all-stock deal, renaming the combined entity Opus Genetics, Inc., set to trade on Nasdaq as 'IRD'. The merger expanded the pipeline with AAV-based gene therapies for inherited retinal diseases and phentolamine ophthalmic solution. Leadership remains with George Magrath, MD as CEO, and Ben Yerxa, PhD as President. The company plans to seek a strategic partner for APX3330, an oral small-molecule inhibitor for diabetic retinopathy, while focusing on gene therapy initiatives like OPGx-LCA5 for LCA5, with early data showing visual improvements. The combined company expects clinical milestones in 2025 and extended its cash runway into 2026.

Ocuphire Pharma's Phase 3 trials (MIRA-2 and MIRA-3) showed phentolamine ophthalmic solution 0.75% (Ryzumvi) rapidly and effectively reverses pharmacologically-induced mydriasis with a favorable safety profile, published in *Ophthalmology*. FDA-approved Ryzumvi, a preservative-free eye drop, significantly reversed mydriasis at 90 minutes compared to placebo, with effects observed as early as 60 minutes. The solution demonstrated a favorable safety profile, with mild and transient adverse events.

Phentolamine ophthalmic solution 0.75% (RYZUMVI™) demonstrated rapid and effective reversal of pharmacologically-induced mydriasis within 60-90 minutes, with significant time savings compared to placebo, according to Phase 3 MIRA-2 and MIRA-3 trials. The solution was approved by the FDA in September 2023 for mydriasis, offering faster recovery and fewer side effects.