作者: Withers, Barbara ; Rahmani, Kavon ; Charizanis, Konstantinos ; Sooch, Mina ; Wirta, David ; Lazar, Audrey ; Coleman, Drey ; Evans, David ; Patel, Ronil ; Jaber, Reda ; Brigell, Mitchell ; Pepose, Jay S

PURPOSEEvaluate safety and efficacy of 0.75% phentolamine ophthalmic solution (POS), an alpha-1 antagonist, in reversal of pharmacologically induced mydriasis.DESIGNTwo Phase 3, multicenter, placebo-controlled, randomized, double-masked clinical trials in healthy subjects.SUBJECTS553 healthy 12 to 80 year old subjects were randomized 1:1 (MIRA-2) and 2:1 (MIRA-3) to receive either POS or placebo eye drops OU.METHODSSubjects received POS or placebo administered 1 hour after mydriasis, induced by instillation of either 2.5% phenylephrine, 1% tropicamide, or Paremyd (1% hydroxyamphetamine / 0.25% tropicamide).MAIN OUTCOME MEASURESPrimary endpoint was percent of subjects returning to ≤0.2 mm greater than baseline pupil diameter in study eye at 90 minutes after POS administration. Safety measures included treatment-emergent adverse events (TEAEs) and tolerability measures, including conjunctival hyperemia.RESULTSIn MIRA-2, 185 subjects were randomized to treatment with placebo (94) or POS (91). In MIRA-3, 368 subjects were randomized to treatment with placebo (124) or POS (244). A statistically significant greater percentage of subjects treated with POS had study eyes that showed reversal of mydriasis at 90 minutes (primary endpoint) compared with the placebo treatment (48.9% vs 6.6% for MIRA-2; p<0.0001 and 58% VS 6% for MIRA-3; p<0.0001) and as early as 60 minutes (24.5% vs 5.5% for MIRA-2; p<0.0003 and 42% VS 2% for MIRA-3; p<0.0001). Between 28 to 34% of placebo-treated subjects had not returned to baseline PD at 24 hours following pharmacological dilation compared to 8 to 11% treated with POS (p<0.0001).CONCLUSIONPOS treatment had a rapid onset in reducing PD within 60- to 90-minutes, with a statistically significant time savings of 3 to 4 hours to return to baseline PD compared to placebo. One or 2 drops of POS rapidly reversed mydriasis in all subjects regardless of mydriatic agent or iris color. More subjects receiving POS 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 1 hour. The safety profile was favorable, with the most common adverse effects being mild transient conjunctival hyperemia (11.2%), instillation site discomfort (10.9%), and dysgeusia (3.6%).

1999-02-01·Optometry and Vision Science4区 · 医学

The Clinical Efficacy of Paremyd with and without Dapiprazole in Subjects with Light and Dark Brown Irides

4区 · 医学

Article

作者: Jaanus, S D ; Dignam, K ; Cooper, J ; Anicho, U M ; Feldman, J

BACKGROUNDParemyd, a mydriatic formulation of 0.25% tropicamide and 1.0% hydroxyamphetamine hydrobromide provides adequate dilation for binocular indirect ophthalmoscopy in young Caucasians. We studied the clinical effectiveness of Paremyd in dilating heavily pigmented eyes by comparing its mydriatic efficacy in Blacks, Asians and Caucasians with light and dark brown irides. We also evaluated the efficacy of one drop of dapiprazole (Rev-Eyes) in reversing Paremyd-induced mydriasis in our subject sample.METHODSIn a masked, randomized, controlled experimental design, several visual functions which included pupillary dilation, near visual acuity, amplitude of accommodation, ocular hyperemia, and discomfort glare were measured at 30-min intervals, for a total of 300 min, in subjects dilated with a single drop of Paremyd in each eye. Ease of binocular indirect ophthalmoscopy was also assessed. A 3-way analysis of variance was used to assess changes in these measures as function of irides color/pigmentation (designated as light or dark brown iris color), presence or absence of dapiprazole, and test time interval.RESULTSWe found that subjects in our light brown irides group (mainly Caucasians) dilated faster than subjects in our dark brown irides group (mainly Blacks). Dapiprazole increased the speed of recovery from pupillary dilation for all subjects, but more so for those with light rather than dark brown irides. Similarly, subjects with light rather than dark brown irides recovered accommodative function more quickly. Although neither the use of dapiprazole nor the degree of iris color/pigmentation was significantly related to visual acuity or glare discomfort, there was a clear trend that these visual measures were affected to a greater degree in subjects with dark brown (primarily Blacks) rather than light brown irides. Overall, Paremyd provided adequate dilation for binocular indirect ophthalmoscopy in all subjects irrespective of iris color/pigmentation.CONCLUSIONSOur data indicate that a single drop of Paremyd provides adequate mydriasis, without significant side effects, for routine fundus examination of all subjects, independent of iris color/pigmentation. Furthermore, a single drop of dapiprazole was effective in speeding the return of pupillary dilation in most subjects, but had no significant effect on accommodation, near visual acuity or glare discomfort. Side effects such as stinging upon instillation, conjunctival hyperemia, and a few instances of ptosis, with possible additional cost to patients, appear to lessen its overall clinical benefit.

1996-11-01·Journal of the American Optometric Association

Pupillary dilation and funduscopy with 1.0% hydroxyamphetamine plus 0.25% tropicamide (Paremyd) versus tropicamide (0.5 or 1.0%) as a function of iris and skin pigmentation, and age.

Article

作者: Feldman, J M ; Appel, S ; Horn, D ; Jaanus, S D ; Appleman, W ; Cooper, J

BACKGROUNDThis study was designed to evaluate the effect of Paremyd, a combination of 1.0 percent hydroxyamphetamine hydrobromide and 0.25 percent tropicamide, on pupil size during binocular indirect ophthalmoscopy (BIO) upon 164 subjects of various skin pigmentation, iris color, and age.METHODSPupillary dilation and ease of performing BIO were measured after 30 minutes following instillation of a single drop of either Paremyd or tropicamide (1.0 or 0.5 percent) to an eye. Subjects were assigned to one of three groups; either Paremyd OU, or Paremyd OS and tropicamide (either 0.5 or 1.0 percent) OD, or Paremyd OD and tropicamide OS. Pupillary dilation was measured during BIO performed at a set illumination using a near point card.RESULTSResults indicate that Paremyd is a significantly more effective dilator than either concentration of tropicamide alone. BIO was rated good to excellent for all dilating agents. As could be expected (based upon data from previous experiments), there was a small, but significant, negative correlation between dilation and age, skin pigmentation, and iris pigmentation.CONCLUSIONSParemyd, because of its superior effect upon dilation without side effects, can be the preferred agent used for routine single-drop dilation in all patients, independent of age, iris color, or skin color.

项与氢溴酸羟苯丙胺/托品卡胺相关的新闻（医药）

2024-09-30

·GlobeNewswire-Health Care

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

Published data from two Phase 3 clinical trials demonstrated rapid reversal of pharmacologically-induced mydriasis with favorable safety profileFARMINGTON 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; andObtaining 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.CFOir@ocuphire.com Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com

临床3期临床结果引进/卖出

2024-04-01

·PRNewswire

Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States

PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States. RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation.1 According to the American Academy of Ophthalmology and the American Optometric Association, clinical practice guidelines recommend dilation as a standard of care.2,3 Dilation allows eye care professionals to identify both common and serious eye health issues, including signs of systemic disease.2,3 The average time of dilation lasts three to eight hours, but can last up to 24 hours in some people.4,5 Prolonged dilation may lead to patients refusing dilation.6,7 Comprehensive dilated eye exams play a vital role in detecting potential vision-impairing ophthalmic conditions such as cataracts and potentially blinding diseases like glaucoma, diabetic retinopathy, and age-related macular degeneration.2,3 Additionally, comprehensive dilated eye exams can uncover evidence of systemic diseases like diabetes, rheumatoid arthritis, and hypertension.2,3 The U.S. Food and Drug Administration (FDA) approved RYZUMVI in September 2023. RYZUMVI was evaluated across 2 randomized, vehicle-controlled, double-masked MIRA-2 and MIRA-3 clinical trials in which patients (N=553) aged 12 to 80 years who had mydriasis induced by instillation of phenylephrine, tropicamide, or PAREMYD® (hydroxyamphetamine hydrobromide and tropicamide) were administered 2 drops (in the study eye) or 1 drop (in the fellow eye) of either RYZUMVI or placebo one hour after instillation of the mydriatic agent. The onset of action of RYZUMVI generally occurs in 30 minutes. In the MIRA-2 and MIRA-3 clinical trials, at 90 minutes after administration, 49% and 58% of patients administered 2 drops of RYZUMVI returned to ≤ 0.2 mm of baseline pupil diameter compared to 7% and 6% of patients administered placebo, respectively. In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours. In the MIRA-3 trials' placebo group, 28% of patients were still dilated at 24 hours.1 RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis). To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.1 The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). For more information on RYZUMVI, visit . About Pharmacologically-Induced Mydriasis An estimated 100 million eye dilations are conducted every year in the U.S. to examine the retina (back-of-the-eye) either for routine check-ups, disease monitoring or surgical procedures.8 Recovery from pharmacologically-induced mydriasis can take three to eight hours, and sometimes lasts 24 hours.4,5 About RYZUMVI ™ (Phentolamine Ophthalmic Solution) 0.75% Indication RYZUMVI™ (phentolamine ophthalmic solution) 0.75% is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. Important Safety Information Warnings and Precautions Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis). Potential for Eye Injury or Contamination: To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses. Adverse Reactions The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). Click here for full Prescribing Information. Forward Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements regarding the U.S. commercial launch of RYZUMVI™ in the United States and that RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Contacts: Media: +1.724.514.1968 [email protected] Jennifer Mauer [email protected] Matt Klein [email protected] Investors: +1.724.514.1813 [email protected] Bill Szablewski [email protected] SOURCE Viatris Inc.

临床结果上市批准

2021-11-23

·BioSpace

Ocuphire Announces Enrollment of First Patients in Second Phase 3 Pivotal Trial (MIRA-3) for Nyxol® in Reversal of Mydriasis (RM)

RM Indication Allows for Rapid Recruitment with Top-line Results Expected in Early 2022 Nyxol has the Potential Opportunity to Address Estimated $500M+ Reversal of Dilation Market with No Approved Therapies Today FARMINGTON HILLS, Mich., Nov. 23, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today announced that the first subjects have been enrolled in the MIRA-3 Phase 3 pivotal trial evaluating Nyxol® Eye Drops in the reversal of pharmacologically-induced mydriasis (dilation of the pupil). With 6 sites enrolling subjects within days of activation and 10 more sites expected to start screening shortly, top-line results from the MIRA-3 trial are expected in early 2022 (around the end of the first quarter). “The safety and efficacy of Nyxol for reversal of mydriasis have been demonstrated in our prior MIRA-1 Phase 2b and MIRA-2 Phase 3 clinical trials,” said Mina Sooch, President and CEO of Ocuphire Pharma. “Both of these trials successfully met their primary and multiple secondary endpoints with statistical significance. We know that over half of patients take 6 hours or longer, sometimes 24 hours, to return to their normal pre-dilated pupil size. Our prior data on Nyxol showed that 50% of patients returned to baseline by 90 minutes and 80% by 3 hours. A positive outcome in MIRA-3 comparable to the results achieved in MIRA-2 will position us to submit an NDA for Nyxol for reversal of mydriasis in late 2022. Successful completion of MIRA-3, as well as our planned smaller pediatric safety study, will bring the total number of patients treated with Nyxol to over 500, out of over 900 study subjects.” David Boyer, M.D., Vitreoretinal Surgeon, Retina-Vitreous Associates Medical Group commented, “Providing the best care to my patients is my top priority. Therefore, I am eager to adopt treatments that enhance the patient experience. As a retinal specialist, there is simply no substitute for dilation when it comes to disease management and treatment, including chronic intravitreal injections for wet AMD or DME. With the ability to return many patients safely to baseline pupil diameter within an hour or two, Nyxol can provide substantial benefit. We dilate almost all of our patients, and I would be excited to offer Nyxol to my patients following dilation in order to optimize their care.” MIRA-3 Trial Design for Nyxol Nyxol is a proprietary, preservative-free, ophthalmic formulation of phentolamine mesylate designed to reduce pupil size by inhibiting or relaxing the iris dilator muscle. MIRA-3 is a multi-center, randomized, parallel-arm, double-masked, placebo-controlled study of the safety and efficacy of Nyxol (0.75% phentolamine ophthalmic solution) to reverse pharmacologically-induced mydriasis in healthy subjects. The MIRA-3 trial is designed to enroll approximately 330 subjects aged 12 and older. After screening, eligible subjects are randomized 2:1 to one of the 2 treatment arms (Nyxol or placebo, respectively) and will receive 1 of 3 approved mydriatic agents approximately 1 hour prior to receiving study treatment drops. Randomization will be 3:1:1 to a mydriatic agent (2.5% phenylephrine, 1% tropicamide, or Paremyd, respectively). The primary efficacy endpoint is the percentage of subjects’ study eyes returning to ≤ 0.2 mm from baseline photopic pupil diameter at 90 minutes. Secondary endpoints include pupil diameter (at multiple time points from 30 minutes to 24 hours), accommodation, and a patient questionnaire, as well as new assessments of glare disability, glare tolerability, and pupillary response to light. Ocuphire is collaborating closely on the Nyxol programs with a leading clinical research organization, Oculos Development Services (subsidiary of iuvo BioScience), which has been instrumental in the successful completion of the first two RM trials. Enrollment of these trials has been remarkably expeditious due to the straightforward trial design and the engagement of experienced optometry and ophthalmic practice sites. Together, there is a high degree of confidence to deliver top-line results in the first quarter of 2022 after just initiating in the middle of this quarter. Edward Holland, M.D., Director of Cornea at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati said, “In current practice, to achieve an optimal examination of the retina, ophthalmologists and optometrists regularly dilate patients to perform monitoring and screening for diseases of the eye. Patients often complain after dilation, citing unwanted symptoms including photophobia, loss of accommodation, inability to read clearly, inability to return to work and subjective discomfort for hours. Other patients actually forgo dilation completely at annual visits, limiting our ability to perform a comprehensive exam. There are no currently approved treatments available, and it is exciting to see the steady advancement towards potential FDA approval for Nyxol. Nyxol is a drop that has demonstrated rapid reversal of dilation in dark and light irides. It can also be used to more quickly reverse the most commonly used mydriatic agents such as phenylephrine and tropicamide. Nyxol could be widely used in our clinical practices, which could increase dilated exams and promote better overall eye health in our patient population.” Reversal of Mydriasis Market Opportunity Every year in the U.S., an estimated 100 million eyes are dilated to examine the back of the eye either for routine check-ups, disease monitoring or surgical procedures across all eye care practice groups. Depending on the individual and the color of their eyes, the pharmacologically-induced dilation can last anywhere from 6 to 24 hours. Dilated eyes have heightened sensitivity to light and an inability to focus on near objects, causing difficulty reading, working, and driving. Market research conducted by GlobalData surveyed several hundred patients and eye care providers (optometrists and ophthalmologists) about Reversal of Mydriasis. Over 65% of surveyed patients reported moderate to severe negative impact of a dilated pupil. These data underscore the potential value of the role of the investigational product candidate Nyxol in improving comfort and daily function after pupil dilation. Furthermore, approximately 80% of patients responded that they would be likely to request a dilation reversal drop, and more than 70% of eye care providers would be likely to use a reversal drop. The market research confirmed the patients’ willingness to pay out-of-pocket to reverse their dilations with an attractive market size estimated at over $500M. Ocuphire is currently evaluating partnering options for an efficient and effective commercial launch of Nyxol targeted for the second half of 2023. About Ocuphire Pharma Ocuphire is a publicly-traded (NASDAQ: OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications. The company’s lead product candidate, Nyxol® (0.75% phentolamine ophthalmic solution) Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, and is being developed for several indications, including reversal of pharmacologically-induced mydriasis (RM), presbyopia and dim light or night vision disturbances (NVD), and has been studied in 9 clinical trials including the recently completed Phase 3 trial in RM and Phase 2 trial in presbyopia. Ocuphire reported positive top-line data in March 2021 for MIRA-2, the first Phase 3 registration trial for treatment of RM, and recently initiated the second Phase 3 registration trial (MIRA-3). Ocuphire also reported positive top-line data in June 2021 for VEGA-1, a Phase 2 trial for the treatment of presbyopia. Nyxol is also currently in Phase 3 clinical development for NVD. Ocuphire’s second product candidate, APX3330, is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME) and has been studied in 11 Phase 1 and 2 trials. APX3330 is currently enrolling subjects in a Phase 2 clinical trial in subjects with DR/DME. As part of its strategy, Ocuphire will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late-stage development, regulatory preparation, and commercialization of drugs in key global markets. Please visit to learn more about Ocuphire’s completed Phase 2 trials, recently completed Phase 3 registration trial in RM (NCT04620213), recently completed Phase 2 trial in presbyopia (NCT04675151), ongoing Phase 3 registration trial in NVD (NCT04638660), and Phase 2 trial in DR/DME (NCT04692688). For more information, visit . Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “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 expected market size, the expected timing of our future clinical trials in RM, NVD, presbyopia, and DR/DME, and the extent of the Company’s cash runway. 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: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) the success and timing of commercialization of any of Ocuphire’s product candidates and (x) the maintenance of 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 and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. 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. Ocuphire Contacts Mina Sooch, President & CEO Ocuphire Pharma, Inc. ir@ocuphire.com Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com

100 项与氢溴酸羟苯丙胺/托品卡胺相关的药物交易

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