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Ocuphire Pharma Announces Publication of Full Phase 3 Results of Phentolamine Ophthalmic Solution 0.75% for Pharmacologically-Induced Mydriasis in Ophthalmology

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Ocuphire Pharma (Nasdaq: OCUP) announced the publication of full results from two pivotal Phase 3 clinical trials (MIRA-2 and MIRA-3) evaluating RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) for treating pharmacologically-induced mydriasis in the journal Ophthalmology. The trials demonstrated that RYZUMVI™ rapidly and effectively reversed pupil dilation with a favorable safety profile.

Key findings include:

  • Statistically significant greater percentage of subjects achieved mydriasis reversal at 90 minutes compared to placebo
  • Effects observed as early as 60 minutes post-administration
  • Fewer subjects had residual dilation at 24 hours post-dilation compared to placebo
  • Most common adverse events were mild and transient

RYZUMVI™ is currently approved for mydriasis treatment and is being evaluated for presbyopia and dim light vision disturbances after keratorefractive surgery in ongoing Phase 3 trials.

Ocuphire Pharma (Nasdaq: OCUP) ha annunciato la pubblicazione dei risultati completi di due importanti studi clinici di Fase 3 (MIRA-2 e MIRA-3) che valutano RYZUMVI™ (Soluzione Oftalmica di Fentolamina 0,75%) per il trattamento della midriasi indotta farmacologicamente, pubblicati sulla rivista Ophthalmology. Gli studi hanno dimostrato che RYZUMVI™ ha invertito rapidamente ed efficacemente la dilatazione della pupilla con un profilo di sicurezza favorevole.

I principali risultati includono:

  • Percentuale statisticamente significativa di soggetti che ha raggiunto la reversibilità della midriasi a 90 minuti rispetto al placebo
  • Effetti osservati già 60 minuti dopo la somministrazione
  • Minor numero di soggetti con dilatazione residua a 24 ore dopo la dilatazione rispetto al placebo
  • Gli eventi avversi più comuni erano lievi e transitori

RYZUMVI™ è attualmente approvato per il trattamento della midriasi ed è in fase di valutazione per la presbiopia e i disturbi della visione in condizioni di scarsa illuminazione dopo intervento di chirurgia keratorefrattiva in studi di Fase 3 in corso.

Ocuphire Pharma (Nasdaq: OCUP) anunció la publicación de los resultados completos de dos importantes ensayos clínicos de Fase 3 (MIRA-2 y MIRA-3) que evalúan RYZUMVI™ (Solución Oftálmica de Fentolamina al 0.75%) para tratar la midriasis inducida farmacológicamente, publicados en la revista Ophthalmology. Los ensayos demostraron que RYZUMVI™ revertió de manera rápida y efectiva la dilatación pupilar con un perfil de seguridad favorable.

Los hallazgos clave incluyen:

  • Porcentaje significativamente mayor de sujetos que lograron la reversión de la midriasis a los 90 minutos en comparación con el placebo
  • Efectos observados tan pronto como a los 60 minutos después de la administración
  • Menor número de sujetos con dilatación residual a las 24 horas después de la dilatación en comparación con el placebo
  • Los eventos adversos más comunes fueron leves y transitorios

RYZUMVI™ está actualmente aprobado para el tratamiento de la midriasis y se está evaluando para la presbicia y alteraciones de visión en condiciones de poca luz después de la cirugía queratorefractiva en ensayos de Fase 3 en curso.

Ocuphire Pharma (Nasdaq: OCUP)는 RYZUMVI™ (0.75% 펜톨라민 안구 용액)의 약리학적으로 유도된 산동 치료에 대한 두 가지 주요 3상 임상 시험 (MIRA-2 및 MIRA-3)의 전체 결과를 안과 저널에 발표했다고 발표했습니다. 이 시험들은 RYZUMVI™가 동공 확장을 빠르고 효과적으로 역전시켰으며, 안전성이 우수하다는 것을 보여주었습니다.

주요 발견은 다음과 같습니다:

  • 플라시보와 비교하여 90분 후에 통계적으로 유의미한 더 많은 비율의 피험자가 산동 역전 달성
  • 투여 후 60분 만에 효과 관찰
  • 플라시보에 비해 24시간 후 잔여 확장이 있는 피험자가 적음
  • 가장 흔한 부작용은 경미하고 일시적임

RYZUMVI™는 현재 산동 치료에 대해 승인되었으며, 진행 중인 3상 시험에서 노안 및 저조도 시력 이상에 대한 평가가 진행되고 있습니다.

Ocuphire Pharma (Nasdaq: OCUP) a annoncé la publication des résultats complets de deux essais cliniques de Phase 3 (MIRA-2 et MIRA-3) évaluant RYZUMVI™ (solution ophtalmique de phentolamine à 0,75 %) pour le traitement de la mydriase induite pharmacologiquement, dans le journal Ophthalmology. Les essais ont démontré que RYZUMVI™ inversait rapidement et efficacement la dilatation de la pupille avec un profil de sécurité favorable.

Les résultats clés comprennent :

  • Pourcentage significativement plus élevé de sujets ayant obtenu la réversion de la mydriase à 90 minutes par rapport au placebo
  • Effets observés dès 60 minutes après l'administration
  • Moins de sujets présentant une dilatation résiduelle 24 heures après la dilatation par rapport au placebo
  • Les événements indésirables les plus courants étaient légers et transitoires

RYZUMVI™ est actuellement approuvé pour le traitement de la mydriase et est évalué pour la presbytie et les troubles de la vision en faible luminosité après chirurgie kératorefractive dans des essais de Phase 3 en cours.

Ocuphire Pharma (Nasdaq: OCUP) hat die Veröffentlichung der vollständigen Ergebnisse von zwei entscheidenden Phase-3-Studien (MIRA-2 und MIRA-3) bekannt gegeben, die RYZUMVI™ (Phentolamin-Augentropfen 0,75%) zur Behandlung der pharmakologisch induzierten Mydriasis in der Zeitschrift Ophthalmology bewerten. Die Studien zeigten, dass RYZUMVI™ die Pupillenerweiterung schnell und effektiv umkehrte und ein günstiges Sicherheitsprofil aufwies.

Wichtige Ergebnisse sind:

  • Statistisch signifikant höherer Prozentsatz der Probanden, die 90 Minuten nach der Behandlung im Vergleich zur Placebo-Gruppe eine Umkehrung der Mydriasis erreichten
  • Effekte, die bereits 60 Minuten nach der Verabreichung beobachtet wurden
  • Weniger Probanden wiesen 24 Stunden nach der Dilatation eine Restdilation im Vergleich zur Placebo-Gruppe auf
  • Die häufigsten unerwünschten Ereignisse waren leicht und vorübergehend

RYZUMVI™ ist derzeit zur Behandlung der Mydriasis zugelassen und wird in laufenden Phase-3-Studien hinsichtlich der Behandlung von Presbyopie und Sehstörungen bei schwachem Licht nach keratorefraktiver Chirurgie bewertet.

Positive
  • RYZUMVI™ demonstrated statistically significant efficacy in reversing pharmacologically-induced mydriasis
  • Favorable safety profile with mild and transient adverse events
  • FDA approval obtained for RYZUMVI™ in mydriasis treatment
  • Ongoing Phase 3 trials for additional indications (presbyopia and dim light vision disturbances)
Negative
  • None.

Insights

The publication of full Phase 3 results for Phentolamine Ophthalmic Solution 0.75% (RYZUMVI™) in Ophthalmology journal is a significant milestone for Ocuphire Pharma. The data demonstrates rapid and effective reversal of pharmacologically-induced mydriasis, with 48.9% and 58% of subjects achieving reversal at 90 minutes in MIRA-2 and MIRA-3 trials, respectively, compared to about 6% for placebo (p<0.0001).

Key points of interest:

  • Statistically significant improvements in pupil diameter as early as 60 minutes post-administration
  • Sustained effects up to 24 hours
  • Fewer subjects with residual dilation at 24 hours (8-11% vs 28-34% for placebo)
  • Favorable safety profile with mild, transient adverse events

The ongoing VEGA-3 and LYNX-2 Phase 3 trials for presbyopia and dim light vision disturbances, respectively, could potentially expand RYZUMVI™'s indications, representing additional market opportunities. These results solidify Ocuphire's position in the ophthalmic pharmaceuticals space and may lead to increased adoption of RYZUMVI™ in clinical practice.

The publication of positive Phase 3 results in a prestigious journal like Ophthalmology enhances Ocuphire Pharma's credibility and may positively impact investor sentiment. Key financial implications include:

  • Market Potential: With RYZUMVI™ already approved and marketed, these results could drive increased adoption and sales, potentially boosting revenue.
  • Pipeline Value: Ongoing Phase 3 trials for presbyopia and dim light vision disturbances represent significant market opportunities. Positive results could substantially increase Ocuphire's valuation.
  • Partnerships: Strong clinical data may attract potential partners or licensees, possibly leading to upfront payments, milestones, or royalties.
  • R&D Efficiency: Successful trials validate Ocuphire's drug development capabilities, potentially reducing perceived risk for future programs.

However, with a market cap of only $33.8 million, Ocuphire appears undervalued relative to its clinical progress and market potential. Investors should monitor upcoming trial results and any changes in institutional ownership or analyst coverage.

Published data from two Phase 3 clinical trials demonstrated rapid reversal of pharmacologically-induced mydriasis with favorable safety profile

FARMINGTON HILLS, Mich., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced the publication of full results from two pivotal Phase 3 clinical trials (MIRA-2 and MIRA-3) that evaluated the safety and efficacy of RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) for the treatment of pharmacologically-induced mydriasis in the peer-reviewed journal Ophthalmology. The results demonstrated that Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, rapidly and effectively reversed pharmacologically-induced pupil dilation with a favorable safety profile.

As previously reported by Ocuphire, in both trials a statistically significant greater percentage of subjects treated with Phentolamine Ophthalmic Solution 0.75% achieved reversal of pharmacologically-induced mydriasis at 90 minutes compared to those receiving placebo, which was the primary endpoint. In the MIRA-2 trial, 48.9% of subjects treated with Phentolamine Ophthalmic Solution 0.75% achieved reversal versus 6.6% in the placebo group (p<0.0001). In the MIRA-3 trial, 58% of subjects treated with Phentolamine Ophthalmic Solution 0.75% achieved the primary endpoint versus 6% in the placebo group (p<0.0001). Effects were observed as early as 60 minutes following administration, with significant improvements in pupil diameter at that timepoint and at every timepoint measured up to 24 hours following administration in both trials. More subjects receiving Phentolamine Ophthalmic Solution 0.75% reported a perceived benefit in the resolution of visual symptoms caused by pharmacologically-induced mydriasis compared to placebo, with statistically significant differences noted as early as one hour following administration.

Fewer subjects treated with Phentolamine Ophthalmic Solution 0.75% (8-11%) had residual dilation at 24 hours post-dilation, compared to placebo-treated subjects (28-34%) (p<0.0001). Phentolamine Ophthalmic Solution 0.75% exhibited a favorable safety profile, with the most common treatment-emergent adverse events being mild and transient, including conjunctival hyperemia (11.2%), instillation site discomfort (10.9%) and dysgeusia (3.6%).

“Routine dilated eye exams are essential for early disease detection, and offering patients faster recovery from mydriasis with minimal side effects enhances the quality of their care,” said David Wirta, M.D., a principal investigator in both trials. “Ocuphire should be proud of the results from these two pivotal trials, which formed the basis of the FDA’s approval of Phentolamine Ophthalmic Solution 0.75% for mydriasis and further validates the scientific rationale of this agent. In addition, the acceptance of the publication in a top ophthalmology journal underscores the significance of the results and the benefit to patients.”  

Phentolamine Ophthalmic Solution 0.75% is approved and marketed as RYZUMVI™ for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide), by Ocuphire’s commercial partner.

Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in presbyopia and dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery. The VEGA-3 Phase 3 clinical trial for presbyopia is actively enrolling, and top-line data are expected in the first half of 2025. The LYNX-2 Phase 3 trial in patients with decreased visual acuity under low light conditions following keratorefractive surgery is also actively enrolling, and top-line data are expected in the first quarter of 2025.

Read the full manuscript of the Ophthalmology publication here: Ophthalmology

MIRA-2 and MIRA-3 Pivotal Trials Design

The MIRA-2 and MIRA-3 trials were randomized, double-masked, placebo-controlled, multi-center, Phase 3 clinical trials evaluating Phentolamine Ophthalmic Solution 0.75% in 553 healthy subjects, from 12 to 80 years old. Subjects were randomized 1:1 (MIRA-2) and 2:1 (MIRA-3) to receive either Phentolamine Ophthalmic Solution 0.75% or placebo eye drops following pharmacologically-induced mydriasis, induced by instillation of either 2.5% phenylephrine, 1% tropicamide or Paremyd (1% hydroxyamphetamine / 0.25% tropicamide). The primary endpoint was the percentage of subjects returning to within 0.2 mm of baseline pupil diameter in the study eye at 90 minutes post-administration, and participants were followed for 24 hours. For more information, please refer to www.ClinicalTrials.gov (NCT04620213 and NCT05134974).

About Pharmacologically Induced Mydriasis

An estimated 100 million eye dilations are conducted every year in the U.S. to examine the retina (i.e., the back of the eye) for routine check-ups, disease monitoring or surgical procedures. Pharmacologically-induced pupil dilation (mydriasis) can last up to 24 hours in adults and children with side effects such as sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work or drive.

About Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution 0.75%, Ocuphire’s late-stage product candidate, is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. It works by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle. Phentolamine Ophthalmic Solution 0.75% is being developed for presbyopia (VEGA-3 Phase 3 trial) and dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery (LYNX-2 Phase 3 trial). A Phase 2 and the first Phase 3 trial for the use of Phentolamine Ophthalmic Solution 0.75% to treat presbyopia met their primary endpoints.

Ocuphire is responsible for managing the VEGA-3 and LYNX-2 trials. Under the terms of the License Agreement, Ocuphire’s partner will reimburse Ocuphire for agreed-to budgeted costs related to the development of Phentolamine Ophthalmic Solution 0.75% through FDA approval, and then share costs above an agreed upon threshold amount.

About Ocuphire Pharma

Ocuphire Pharma, Inc. (Nasdaq: OCUP) is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small molecule therapies for the treatment of patients with retinal and refractive eye disorders. Ocuphire’s late-stage candidate, Phentolamine Ophthalmic Solution 0.75%, is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. It is being developed for presbyopia and dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in the VEGA-3 Phase 3 trial for the treatment of presbyopia and in the LYNX-2 Phase 3 trial for the treatment of decreased visual acuity under mesopic (low) light conditions following keratorefractive surgery. A Phase 2 and the first Phase 3 trial for the use of Phentolamine Ophthalmic Solution 0.75% to treat presbyopia met their primary endpoints.

For more information, please visit www.ocuphire.com

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the efficacy and safety of Phentolamine Ophthalmic Solution 0.75% in the treatment of presbyopia and dim (mesopic) light vision disturbances, logistical details regarding the upcoming VEGA-3 Phase 3 clinical trial, and continued drug development and marketing under our partnership agreement.

These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.

These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:

  • The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;
  • Regulatory requirements or developments;
  • Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;
  • Delays or difficulties in the enrollment of patients in clinical trials;
  • Substantial competition and rapid technological change;
  • Our development of sales and marketing infrastructure;
  • Future revenue losses and profitability;
  • Our relatively short operating history;
  • Changes in capital resource requirements;
  • Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs;
  • Domestic and worldwide legislative, regulatory, political and economic developments;
  • Employee misconduct;
  • Changes in market opportunities and acceptance;
  • Reliance on third parties;
  • Future, potential product liability and securities litigation;
  • System failures, unplanned events, or cyber incidents;
  • The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;
  • Risks that our partnership or other licensing arrangements, may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates;
  • Future fluctuations in the market price of our common stock;
  • The success and timing of commercialization of any of Ocuphire’s product candidates; and
  • Obtaining and maintaining Ocuphire’s intellectual property rights.

The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the Securities and Exchange Commission that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

Corporate Investor Relations 
Nirav Jhaveri, M.B.A.
CFO
ir@ocuphire.com 

Corey Davis, Ph.D. 
LifeSci Advisors 
cdavis@lifesciadvisors.com



FAQ

What were the primary results of Ocuphire Pharma's (OCUP) Phase 3 trials for RYZUMVI™?

In the MIRA-2 trial, 48.9% of subjects treated with RYZUMVI™ achieved mydriasis reversal versus 6.6% in the placebo group. In MIRA-3, 58% of RYZUMVI™-treated subjects achieved reversal versus 6% in the placebo group. Both results were statistically significant (p<0.0001).

What is the current FDA-approved indication for Ocuphire's (OCUP) RYZUMVI™?

RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) is FDA-approved for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents.

What additional indications is Ocuphire Pharma (OCUP) exploring for RYZUMVI™?

Ocuphire is currently evaluating RYZUMVI™ in Phase 3 trials for presbyopia (VEGA-3 trial) and dim light vision disturbances after keratorefractive surgery (LYNX-2 trial).

When are the top-line results expected for Ocuphire's (OCUP) ongoing Phase 3 trials?

Top-line data for the VEGA-3 trial in presbyopia are expected in the first half of 2025, while results for the LYNX-2 trial are anticipated in the first quarter of 2025.

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