OCUP Ocuphire Pharma Inc.

3.09
-0.11  -3%
Previous Close 3.2
Open 3.19
52 Week Low 3.1901
52 Week High 13.812
Market Cap $58,233,609
Shares 18,845,828
Float 17,347,932
Enterprise Value $62,363,608
Volume 452,994
Av. Daily Volume 2,308,909
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Upcoming Catalysts

Drug Stage Catalyst Date
Nyxol Eye Drops - (MIRA-4)
Mydriasis in patients aged 3-11
Phase 3
Phase 3
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Nyxol Eye Drops - (LYNX-1)
Dim Light or Night Vision Disturbances (DLD)
Phase 3
Phase 3
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Nyxol Eye Drops - (MIRA-3)
Reversal of Mydriasis (RM)
Phase 3
Phase 3
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APX3330 Oral Pill - (ZETA-1)
Diabetic Retinopathy (DR)/ Macular Edema (DME)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Nyxol + Low-Dose Pilocarpine Eye Drops (VEGA-2/VEGA-3)
Presbyopia
Phase 3
Phase 3
Phase 3 trial to be initiated in 1H 2022.

Latest News

  1. Completed Enrollment of Nyxol® LYNX-1 Phase 3 NVD Trial

    Initiated Enrollment of Nyxol MIRA-4 Pediatric Study in RM per Agreed Initial Pediatric Study Plan with FDA

    Nyxol MIRA-3 Phase 3 Results, MIRA-4 Pediatric Results, and LYNX-1 Phase 3 Results Expected in Early 2022

    Strengthened Balance Sheet Extends Runway into Q2 2023

    Company to Host Virtual Investor R&D Day on January 31st

    FARMINGTON HILLS, Mich., Jan. 05, 2022 (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 provided a corporate update available on the Company's website. This update includes recent progress…

    Completed Enrollment of Nyxol® LYNX-1 Phase 3 NVD Trial

    Initiated Enrollment of Nyxol MIRA-4 Pediatric Study in RM per Agreed Initial Pediatric Study Plan with FDA

    Nyxol MIRA-3 Phase 3 Results, MIRA-4 Pediatric Results, and LYNX-1 Phase 3 Results Expected in Early 2022

    Strengthened Balance Sheet Extends Runway into Q2 2023

    Company to Host Virtual Investor R&D Day on January 31st

    FARMINGTON HILLS, Mich., Jan. 05, 2022 (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 provided a corporate update available on the Company's website. This update includes recent progress on Nyxol® trials, the Company's cash position, and the announcement of an Investor R&D day in late January.

    "We are looking forward to a catalyst-rich 2022 and the opportunity to build on the tremendous progress over the past year advancing our differentiated therapeutic candidates in front and back of the eye indications," stated Mina Sooch, MBA, President and CEO. "Our development program for Nyxol in the Reversal of Mydriasis (RM) indication is now in its final stages. We have recently agreed on an Initial Pediatric Study Plan (iPSP) with the FDA and began enrolling pediatric subjects ages 3 to 11 in the MIRA-4 study in late December. We also continue to enroll adults and 12 to 17 year-old subjects in MIRA-3, which is the second pivotal trial for the RM indication expected to read-out around the end of the first quarter. A positive outcome in MIRA-3 will position us to submit an NDA for Nyxol for RM in late 2022. We are also happy to report that this week marks the completion of over 140 subjects enrolled in LYNX-1, a Phase 3 pivotal trial for Nyxol in Night Vision Disturbances (NVD). We look forward to providing clinical updates on Nyxol in presbyopia and RM as well as APX3330 in diabetic retinopathy at our upcoming Virtual Investor R&D Day."

    Initiated Enrollment in MIRA-4 Pediatric Trial in Reversal of Mydriasis: Ocuphire recently enrolled the first subjects in MIRA-4, which is a randomized, double-masked, placebo-controlled study of Nyxol eye drops to reverse pharmacologically-induced mydriasis in healthy pediatric subjects. Approximately 20 pediatric subjects ages 3 to 11 will be enrolled with safety as the primary objective and efficacy as secondary objectives. Nyxol has the potential to address an estimated $500 million reversal of dilation market across pediatrics and adults, which has no current commercially available therapies.

    Completed Enrollment of LYNX-1 Study in Night Vision Disturbances: Enrollment has been completed in the LYNX-1 Phase 3 clinical trial investigating Nyxol for the treatment of NVD. LYNX-1 is a randomized, double-masked, placebo-controlled registration study designed to evaluate the safety and efficacy of Nyxol compared to placebo in patients with NVD. NVD, also known as dim light vision disturbances (DLD), is a condition in which peripheral imperfections (aberrations) of the cornea scatter light when the pupil naturally dilates in dim light conditions. Patients with NVD commonly experience visually impeding glare, halos, starbursts and decreased contrast sensitivity. Based on GlobalData market research, about 38 million individuals in the US are believed to suffer from NVD. An estimated 16 million individuals have moderate-to-severe NVD that may benefit from Nyxol's ability to reduce the pupil diameter and provide better night vision by eliminating the peripheral aberrations.

    Key Anticipated 2022 Milestones:

    • Reversal of Mydriasis (RM): Report top-line results in early 2022 from the Nyxol Phase 3 MIRA-3 registration trial and the MIRA-4 pediatric trial; Planning to file an NDA with FDA for Nyxol in RM indication in late 2022



    • Presbyopia: Initiate Phase 3 program (VEGA 2/VEGA 3) in 1H 2022 investigating Nyxol and low-dose pilocarpine (LDP)



    • Night Vision Disturbances (NVD): Report top-line results in early 2022 from the Nyxol Phase 3 LYNX-1 trial



    • Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results in 2H 2022 from the APX3330 Phase 2 ZETA-1 trial

    $24.5M Cash at Year End: As of December 31, 2021, Ocuphire had cash and cash equivalents of approximately $24.5 million. We expect that our strengthened balance sheet will support operations into the second quarter of 2023, as compared to previous guidance of late 2022. Ocuphire had 18.8 million shares of common stock outstanding as of year-end.

    Panel Discussion at LifeSci Partners Corporate Access Event on January 6, 2022: Mina Sooch, MBA, President, CEO and Founder, will participate in a virtual panel discussion "The Role of Gender Equality in Changing the Landscape of Life Sciences Innovation & Investment" during the LifeSci Partners 11th Annual Corporate Access Event on Thursday, January 6th, 12:00 to 12:55pm ET. To access the panel, please register here.

    Company to Host Investor R&D Day on Monday, January 31, 2022: Ocuphire will host a Virtual Investor R&D Day for the investment community at which six ophthalmic Key Opinion Leaders (KOLs) from retina, optometry and refractive surgery practices will share their thoughts on three large unmet indications, RM, presbyopia, and DR/DME, addressed by Ocuphire's two late-stage clinical drug assets and provide status updates on the development programs for Nyxol and APX3330. The event will take place from 10:00am to 12:00pm ET on Monday, January 31st and will feature insights from David Boyer, M.D., Peter Kaiser, M.D., Paul M. Karpecki, O.D., F.A.A.O., James Katz, M.D., Mitchell Jackson, M.D., and Jay S. Pepose, M.D., Ph.D. To access the event, please register here.

    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 refractive and retinal eye disorders. Ocuphire's pipeline currently includes two small-molecule product candidates targeting multiple front and back of the eye indications. The company's lead product candidate, Nyxol® (0.75% phentolamine ophthalmic solution), 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. 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) in RM. Ocuphire also reported positive top-line data in June 2021 for VEGA-1, a well-controlled Phase 2 trial for the treatment of presbyopia. The Phase 3 clinical trial for Nyxol in NVD patients (LYNX-1) also recently fully enrolled. 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 www.clinicaltrials.gov to learn more about Ocuphire's ongoing 2nd Phase 3 registration trial in RM (NCT05134974) and Phase 2 trial in DR/DME (NCT04692688). For more information on the recently completed trials, see the links to the 1st Phase 3 registration trial in RM (NCT04620213), Phase 2 trial in presbyopia (NCT04675151), and Phase 3 registration trial in NVD (NCT04638660). For more information, visit www.ocuphire.com.

    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 future clinical trials in RM, presbyopia, NVD and DR/DME, and statements regarding 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. 



    www.ocuphire.com

    Corey Davis, Ph.D.

    LifeSci Advisors



    Primary Logo

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  2. FARMINGTON HILLS, Mich, Dec. 08, 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 it has appointed six new key opinion leaders (KOLs) across retina, refractive surgery, and optometry to its Medical Advisory Board (MAB).

    "The opportunity to assemble such a dynamic and admired roster of medical advisors is exciting and will certainly broaden Ocuphire's potential," said Mina Sooch, Founder and CEO of Ocuphire Pharma. "In the medical community, their clinical expertise and knowledge of ophthalmic drug development have earned them global distinction…

    FARMINGTON HILLS, Mich, Dec. 08, 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 it has appointed six new key opinion leaders (KOLs) across retina, refractive surgery, and optometry to its Medical Advisory Board (MAB).

    "The opportunity to assemble such a dynamic and admired roster of medical advisors is exciting and will certainly broaden Ocuphire's potential," said Mina Sooch, Founder and CEO of Ocuphire Pharma. "In the medical community, their clinical expertise and knowledge of ophthalmic drug development have earned them global distinction as key thought-leaders, panelists, authors, clinical investigators, and commercial launch experts in the field of ophthalmology. We look forward to their invaluable contributions and insights as we advance our lead clinical assets, Nyxol® and APX3330 in reversal of mydriasis, presbyopia, night vision disturbance, and diabetic eye diseases."

    Jay Pepose, M.D., Ph.D., Member of Ocuphire's Board of Directors and MAB commented, "We are privileged to have the opportunity to expand Ocuphire's roster of thought-leaders. Over the last three years, our thirteen-member MAB has been vital in the design of our well-executed clinical trials, participating in regulatory interactions, and advancing discussions with global ophthalmic strategic partners. Additionally, the MAB has played an important role in presenting Nyxol and APX3330 to the medical community through peer-reviewed publications and industry conferences. The addition of these six world-class individuals, many of whom I have had the privilege of working with over several decades, will help to advance Ocuphire's portfolio of innovative drug candidates to address unmet medical needs of our patients."

    The new members of the Medical Advisory Board are:

    Retinal Specialists

    • David Brown, M.D. F.A.C.S. is the director of research at Retina Consultants of Texas, chairs the Medical Leadership Board of Retina Consultants of America (RCA), and serves on the RCA board of directors. Additionally, Dr. Brown is a Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research for Houston Methodist Hospital, and is a member of NASA's research and clinical advisory panel. Dr. Brown is a renowned leader in the retina and has published over 500 national meeting presentations, abstracts, and scientific papers, including many of the primary papers that established the use of anti-VEGF agents for AMD, retinal vein occlusion, and diabetic retinopathy (DR). He serves as a peer-reviewer for 8 ophthalmology journals and has authored 9 book chapters. Dr. Brown is an investigator in Ocuphire's ZETA-1 Phase 2 clinical trial evaluating the safety and efficacy of oral APX3330 in patients with diabetic retinopathy.
    • David Lally, M.D. F.A.S.R.S. is a retina surgeon at Baystate Medical Center, an Assistant Professor of Ophthalmology at the University of Massachusetts Medical School-Baystate, and the director of the Retina Research Institute at New England Retina Consultants. His work has been published in over 25 articles in peer-reviewed ophthalmic journals, and he has delivered over 25 presentations at national meetings. Dr. Lally is part of several clinical trial steering committees and an exceptional recruiter as principal investigator in numerous retina clinical trials. Dr. Lally is an investigator in Ocuphire's ZETA-1 Phase 2 clinical trial.

    Refractive Surgeons

    • Y. Ralph Chu, M.D. is the CEO and Chief Medical Officer of the Chu Vision Institute and Chu Surgery Center in Minnesota. Dr. Chu is an internationally recognized leader, innovator, and pioneer of new technologies in cataract and refractive surgery and has been involved in over 95 clinical trials across various ophthalmic diseases. He has published over 100 national meeting presentations, abstracts, and scientific papers. Dr. Chu has also been a member of several product launch committees for refractive surgery products. Dr. Chu is a clinical investigator in Ocuphire's MIRA-3 Phase 3 clinical trial evaluating the safety and efficacy of Nyxol for reversal of mydriasis.
    • James Katz, M.D. is a board-certified ophthalmologist at the Midwest Center for Sight in Chicago. Dr. Katz specializes in cornea, cataract, and refractive surgery and is well-published in distinguished ophthalmologic journals with over 50 publications and over 300 presentations. He is an editorial board member of ophthalmology publications, including Cataract & Refractive Surgery Today and Presbyopia Physician. Dr. Katz has been a principal investigator in numerous FDA trials including several studies for the treatment of presbyopia. Dr. Katz speaks and teaches nationally and internationally on cataract, presbyopia and refractive surgery, and has received several notable awards and distinctions including the American Academy of Ophthalmology Achievement Award and the CEDARS ASPENS Founders Award.
    • Mitchell A. Jackson, M.D. is the founder and CEO of Jacksoneye in Illinois and has practiced as a comprehensive ophthalmologist for 28 years. Dr. Jackson has been involved in over 40 pharmaceutical and surgical device clinical studies, including several presbyopia studies. Dr. Jackson serves on 7 editorial advisory boards, including Presbyopia Physician. Dr. Jackson serves as a member of the medical advisory board of several companies, and a speaker for some of the largest ophthalmic companies. Dr. Jackson has been voted Best Cataract Surgeon in America 2021 as well as a Top 50 global Key Opinion Leaders (KOL). He is a clinical investigator in Ocuphire's MIRA-3 Phase 3 clinical trial.

    Optometrists

    • Douglas Devries, O.D. is the co-founder of Eye Care Associates of Nevada and Associate Clinical Professor of Optometry. Dr. Devries has participated in numerous clinical trials and has published over 500 national and international meeting presentations, lectures, abstracts, and scientific papers. He is an advisor and speaker for some of the largest ophthalmic pharmaceutical and device companies. He is a clinical investigator in Ocuphire's MIRA-3 Phase 3 clinical trial.

    Additional information and biographies are available at: https://www.ocuphire.com/about/medical-advisory-board

    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) in RM. 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 www.clinicaltrials.gov to learn more about Ocuphire's ongoing Phase 3 (2nd) registration trial in RM (NCT05134974), Phase 3 registration trial in NVD (NCT04638660), and Phase 2 trial in DR/DME (NCT04692688). Ocuphire recently completed a Phase 3 (1st) registration trial in RM (NCT04620213), and a Phase 2 trial in presbyopia (NCT04675151). For more information, visit www.ocuphire.com.

    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 future clinical trials in RM, presbyopia, NVD and DR/DME. 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. 

     

    www.ocuphire.com

    Corey Davis, Ph.D.

    LifeSci Advisors



    Primary Logo

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  3. 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…

    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 www.clinicaltrials.gov 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 www.ocuphire.com.

    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. 

     

    www.ocuphire.com

    Corey Davis, Ph.D.

    LifeSci Advisors



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  4. On Track to Initiate Additional Phase 3 FDA Registration Trials for Nyxol® Eye Drops in Reversal of Mydriasis (RM) in 4Q21 and Presbyopia in 1H22

    Three Clinical Trial Data Readouts Expected in Early 2022 for Nyxol in Night Vision Disturbance, RM, and RM for Pediatric Patients

    Planned NDA Submission for Nyxol in Reversal of Mydriasis Indication in Late 2022

    More Publications Supporting Novel Transcription Factor (Ref-1) Inhibitor, APX3330, Targeting Both Neovascularization and Inflammation in Retinal Diseases

    Currently Recruiting for Phase 2 Trial Evaluating APX3330 for the Treatment of Diabetic Retinopathy with Data Expected in 2H22

    FARMINGTON HILLS, Mich., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage…

    On Track to Initiate Additional Phase 3 FDA Registration Trials for Nyxol® Eye Drops in Reversal of Mydriasis (RM) in 4Q21 and Presbyopia in 1H22

    Three Clinical Trial Data Readouts Expected in Early 2022 for Nyxol in Night Vision Disturbance, RM, and RM for Pediatric Patients

    Planned NDA Submission for Nyxol in Reversal of Mydriasis Indication in Late 2022

    More Publications Supporting Novel Transcription Factor (Ref-1) Inhibitor, APX3330, Targeting Both Neovascularization and Inflammation in Retinal Diseases

    Currently Recruiting for Phase 2 Trial Evaluating APX3330 for the Treatment of Diabetic Retinopathy with Data Expected in 2H22

    FARMINGTON HILLS, Mich., Nov. 12, 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 financial results for the third quarter of 2021 and provided a corporate update.

    "The third quarter marked continued progress across our late-stage clinical programs and opportunities for multiple data presentations at major medical meetings," said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. "We have already achieved two successful clinical trials for Nyxol. In reversal of mydriasis (RM), we reported positive results in a Phase 3 trial and are on track to initiate the second Phase 3 trial before year end. In presbyopia, we reported positive results in a Phase 2 clinical trial. We are also delighted to see the early US regulatory approval of Allergan's VUITYTM eye drops, the first pharmaceutical therapy for the large presbyopia market."

    "We are also very pleased to see a growing body of supportive research for our Phase 2 oral drug candidate, APX3330, which inhibits known pro-angiogenic and pro-inflammatory pathways. As a highly differentiated, first-in-class and orally-delivered therapy, we believe APX3330 will be an important source of potential value creation with the opportunity to broadly address the unmet global clinical need in diabetic retinopathy and treatment burden in other retinal diseases."

    "This week marks Ocuphire's one-year anniversary of public trading on the Nasdaq and we are proud to have achieved so many important clinical and business milestones in that time. We thank our clinical trial participants and investigators for their continued support. Looking ahead, we believe 2022 is shaping up to be an even more exciting and catalyst-rich year to build significant value for our company and our shareholders, with cash on hand that provides runway into late 2022 to achieve these milestones."

    Key Anticipated Future Milestones

    • Reversal of Mydriasis (RM): Initiate second Phase 3 (MIRA-3) registration trial in subjects 12 and older and a small pediatric trial in subjects ages 3 to 11 (MIRA-4) in the fourth quarter of 2021 investigating Nyxol with results expected in early 2022; Planning to file NDA submission with FDA for Nyxol in RM indication in late 2022
    • Presbyopia: Initiate Phase 3 program (VEGA-2) in first half of 2022 investigating Nyxol and Low-Dose Pilocarpine (LDP)
    • Night Vision Disturbances (NVD): Top-line data expected in early 2022 from Phase 3 (LYNX-1) registration trial investigating Nyxol
    • Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Top-line data expected in the second half of 2022 for the randomized, well-controlled Phase 2 (ZETA-1) trial investigating APX3330

    Third Quarter and Recent Business Highlights

    Presentations and Publications

    • In November, clinical data on Nyxol® and APX3330 were accepted for presentation at poster sessions at the American Academy of Ophthalmology (AAO) 2021 annual meeting to take place in New Orleans, November 12 – 15. In addition, Ocuphire presented new data on improvement in intermediate vision and Snellen equivalent near vision at the  2021 conference on November 11. Ocuphire was one of two companies presenting clinical data for presbyopia at this meeting.
    • In October, the Company announced the publication of a review article within the Special Issue "Advances in Molecular Activity of Potential Drugs" of the International Journal of Molecular Sciences, focused on how novel inhibitors of APE1/Ref-1 such as APX3330 may have the potential to improve disease outcomes for retinal disease patients. The article underscores the role of the APE1/Ref-1 protein in pro-angiogenic pathways associated with neovascular eye disease including diabetic retinal diseases and age-related macular degeneration. It can be accessed online at the following link: Inhibition of APE1/Ref-1 for Neovascular Eye Disease: From Biology to Therapy.
    • In October, the Company announced the publication of a review article in Cells titled "Potential Therapeutic Candidates for Age-Related Macular Degeneration" noting the potential of APX3330 (referred to as "E3330") for the treatment of age-related macular degeneration (AMD). Because APE1/Ref-1 has been shown to contribute to retinal angiogenesis, the authors conclude that APE1/Ref-1 inhibitors such as APX3330 could inhibit the abnormal blood vessel formation seen in AMD by reducing retinal endothelial cell proliferation, migration, and tube formation. The article can be accessed online at the following link: Potential Therapeutic Candidates for Age-Related Macular Degeneration (AMD).
    • In October, Michael J. Allingham, MD, PhD presented at the 39th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) (Diabetic Retinopathy 1 Symposium), highlighting the favorable safety and tolerability data for APX3330 in over 300 healthy volunteers and cancer/inflammation disease patients across 11 Phase 1 and Phase 2 studies. Also, Mina Sooch, CEO, presented APX3330 history and the design of the ongoing Phase 2 trial in DR at the OIS Retina Innovation .
    • In July, the Company announced publication in the Journal of Cellular Signaling featuring Ocuphire's novel oral Ref-1 inhibitor APX3330 in Phase 2 trial for the treatment of retinal disease which highlighted the favorable safety profile of APX3330 and its unique anti-angiogenic and anti-inflammatory mechanism of action properties relevant to a broad range of retinal diseases.
    • In July, at the 2021 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, Dr. Jay S. Pepose, Medical Advisor and Board Director, presented papers featuring positive results for Nyxol in two studies: Phase 2 Presbyopia (VEGA-1) and Phase 3 Reversal of Mydriasis (MIRA-2). The Phase 3 MIRA-2 data presentation at ASCRS won the Best Paper of the Session.
    • In July, Mina Sooch, CEO, participated in the presbyopia drug therapy panel at the 2021 held on July 22nd and in the Eye on Innovation panel at the Virtual Salon Series held on July 28th.

    Intellectual Property

    • U.S. Patent and Trademark Office issued patent no. 11,160,770 "Compounds, compositions and methods for treating oxidative DNA damage disorders" which provides protection for APX2009 and other APX pipeline candidates.

    Third Quarter and Year-To-Date 2021 Financial Highlights

    As of September 30, 2021, the Company had cash and cash equivalents of approximately $22.2 million. Net cash used in operating activities for the nine months ended September 30, 2021 was $13.7 million.

    Collaborations revenue was $0.5 million and $0.6 million for the three months and nine months ended September 30, 2021, respectively. Revenue during the periods was derived from the license agreements with Biosense Global, LLC and Processa Pharmaceuticals, Inc. related to certain technology transfers. There was no collaborations revenue recognized during the comparable prior year periods.

    General and administrative expenses for the three months and nine months ended September 30, 2021 were $1.6 million and $6.7 million, respectively, compared to $0.6 million and $1.5 million for the comparable periods in 2020, respectively. The increases in the current periods were primarily attributable to administrative employee headcount, stock-based compensation, professional services, insurance, legal and settlement costs, and costs associated with operating as a public company subsequent to the reverse merger.

    Research and development expenses for the three months and nine months ended September 30, 2021 were $3.1 million and $10.4 million, respectively, compared to $1.4 million and $2.3 million for the comparable periods in 2020, respectively. In the current periods, the increases were primarily attributable to new clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical and other development activities.

    The loss from operations for the three and nine months ended September 30, 2021 was $4.2 million and $16.6 million, respectively, compared to $1.9 million and $5.9 million for the three and nine months ended September 30, 2020, respectively.

    There was a non-cash expense of $33.8 million related to fair value change in warrant liabilities recorded for the nine months ended September 30, 2021 compared to a benefit of $0.2 million recorded for the nine months ended September 30, 2020 related to premium conversion derivatives. The reported losses also included non-cash stock-based compensation expense of $0.5 million and $1.4 million during the three and nine months ended September 30, 2021, respectively, and $0.6 million and $1.0 million during the three and nine months ended September 30, 2020, respectively.

    For further details on Ocuphire's financial results refer to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the Securities and Exchange Commission.

    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 topline data in March 2021 for MIRA-2, a Phase 3 FDA registration study for treatment of RM. 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 www.clinicaltrials.gov 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, please visit www.ocuphire.com.

    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 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. 

     

    www.ocuphire.com

    Corey Davis, Ph.D.

    LifeSci Advisors

    Ocuphire Pharma, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share amounts and par value)

      
     As of
      September 30,  December 31, 
      2021  2020 
     (unaudited) 
    Assets  
    Current assets:  
    Cash and cash equivalents$22,250 $16,399 
    Short-term investments 383   
    Prepaids and other assets 560  1,269 
    Total current assets 23,193  17,668 
    Property and equipment, net 11  14 
    Total assets$23,204 $17,682 
       
    Liabilities and stockholders' equity (deficit)  
    Current liabilities:  
    Accounts payable$1,434 $1,214 
    Accrued expenses 1,204  1,971 
    Total current liabilities 2,638  3,185 
    Warrant liabilities   27,964 
    Total liabilities 2,638  31,149 
       
    Commitments and contingencies  
       
    Stockholders' equity (deficit)  
    Preferred stock, par value $0.0001; 10,000,000 shares authorized as of September 30, 2021 and December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020.    
    Common stock, par value $0.0001; 75,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 17,295,434 and 10,882,495 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively. 2  1 
    Additional paid-in-capital 103,619  19,207 
    Accumulated deficit (83,055) (32,675)
    Total stockholders' equity (deficit) 20,566  (13,467)
    Total liabilities and stockholders' equity (deficit)$23,204 $17,682 



    Ocuphire Pharma, Inc.

    Condensed Consolidated Statements of Comprehensive Loss

    (in thousands, except share and per share amounts)

    (unaudited)

     For the Three Months Ended

     For the Nine Months Ended 
     September 30, 

     September 30, 

      2021   2020   2021   2020 
    Collaborations revenue$489  $  $589  $ 
                    
    Operating expenses:               
    General and administrative 1,595   565   6,707   1,508 
    Research and development 3,126   1,383   10,437   2,311 
    Acquired in-process research and development          2,126 
    Total operating expenses 4,721   1,948   17,144   5,945 
    Loss from operations (4,232)  (1,948)  (16,555)  (5,945)
    Interest expense    (179)     (1,422)
    Fair value change of warrant liability and premium conversion derivatives    879   (33,829)  158 
    Gain on note extinguishment          1,260 
    Other income, net 2      4   9 
    Loss before income taxes (4,230)  (1,248)  (50,380)  (5,940)
    Benefit (provision) for income taxes           
    Net loss (4,230)  (1,248)  (50,380)  (5,940)
    Other comprehensive loss, net of tax           
    Comprehensive loss$(4,230) $(1,248) $(50,380) $(5,940)
    Net loss per share:               
    Basic and diluted$(0.25) $(0.33) $(3.64) $(1.61)
    Number of shares used in per share calculations:               
    Basic and diluted 16,925,006   3,743,907   13,841,067   3,678,840 


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  5. FDA Approves First Pharmaceutical Therapy to Treat Presbyopia; Nyxol on Track to Start Phase 3 Presbyopia Trials in First Half of 2022

    Ocuphire Uniquely Positioned in Developing Late-Stage Innovative Therapies for Retinal Disease and Presbyopia

    FARMINGTON HILLS, Mich., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced that clinical data on its therapeutic candidates Nyxol® and APX3330 will be featured in poster sessions as presentations at the upcoming American Academy of Ophthalmology (AAO) 2021 annual meeting to take place in New Orleans, November 12…

    FDA Approves First Pharmaceutical Therapy to Treat Presbyopia; Nyxol on Track to Start Phase 3 Presbyopia Trials in First Half of 2022

    Ocuphire Uniquely Positioned in Developing Late-Stage Innovative Therapies for Retinal Disease and Presbyopia

    FARMINGTON HILLS, Mich., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced that clinical data on its therapeutic candidates Nyxol® and APX3330 will be featured in poster sessions as presentations at the upcoming American Academy of Ophthalmology (AAO) 2021 annual meeting to take place in New Orleans, November 12 – 15. In addition, Ocuphire will present at the 2021 satellite symposium on November 11.

    "We are delighted to see the early US regulatory approval of Allergan's eye drops, the first pharmaceutical therapy to be approved for the treatment of presbyopia," said Mina Sooch, President & CEO of Ocuphire. "Presbyopia represents an area of significant growth and market opportunity with over 120 million Americans living with presbyopia and dependent on reading glasses. Based upon our positive Phase 2 study results reported this year, we believe that Nyxol and low dose pilocarpine (LDP) represents a novel mechanism of action with a differentiated safety, efficacy, and durability profile. We plan to initiate our Phase 3 trials for presbyopia in the first half of 2022. We believe that Nyxol's clinical profile holds the potential as a best-in-class therapy for the treatment of presbyopia."

    AAO 2021 Subspecialty Day Presentation Details

    Title: Favorable Safety and Tolerability Profile of Oral APX3330 Drives Dosing Strategy for Ongoing Phase 2 Trial for DR/DME
    Subspecialty Day: Retina, Friday and Saturday, November 12-13, 2021
    Abstract#: PO332 (link)
    Presenting author: Michael J. Allingham, MD, PhD

    Dr. Allingham will present safety data on oral APX3330 from over 300 healthy volunteers and patients with chronic hepatitis across five Phase 1 and five Phase 2 clinical trials at doses up to 600 mg/day. A sixth Phase 1 study will also be presented, showing safety data from 19 patients with solid tumors who were treated with daily oral dosing of APX3330 of up to 720 mg/day. Additional preclinical data on MOA in normal cells and PK exposure data will be presented. The aggregate clinical data from these 11 completed trials support Ocuphire's ZETA-1 Phase 2b study, an ongoing, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of oral APX3330 in the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME). Additional information about the ZETA-1 Phase 2b trial can be found at www.clinicaltrials.gov (NCT04692688).

    Title:  Phase 2 Clinical Trial to Evaluate the Efficacy of Phentolamine Ophthalmic Solution and Low-Dose Pilocarpine for the Treatment of Presbyopia
    Subspecialty Day: Refractive Surgery, Friday and Saturday, November 12-13, 2021
    Abstract #:  30068457 (link)
    Presenting Author:  Jay S. Pepose, MD, PhD

    Dr. Pepose will present results from the VEGA-1 Phase 2 multi-center, randomized, placebo-controlled, double-masked clinical trial which evaluated a kit combination of Nyxol, 0.75% phentolamine ophthalmic solution (POS), plus low-dose 0.4% pilocarpine (LDP) for the treatment of presbyopia. Ocuphire reported top line positive data from VEGA-1 earlier this year. The VEGA-1 study enrolled 150 presbyopic patients at 17 investigational sites in the US. On the primary endpoint, 61% of subjects treated with Nyxol + LDP improved 15 letters or greater (≥ 3 lines) in photopic binocular near vision at 1 hour compared with 28% of subjects on placebo (33% placebo adjusted difference; p= 0.003). Treatment with Nyxol and/or LDP did not reduce best corrected distance vision. Moreover, Nyxol and/or LDP was well tolerated with no headaches and had a durable effect measured up to 6 hours. Additional information about the VEGA-1 Phase 2 trial can be found at www.clinicaltrials.gov (NCT04675151).

    2021

    Company Showcase: Retina, Cornea, Glaucoma & Anterior Segment
    Session Room:  Glaucoma & Anterior Segment
    Time: 11:30am Central US / 12:30pm Eastern US
    Date:  November 11, 2021
    Presenter Mina Sooch, M.B.A., CEO Ocuphire

    Eyecelerator is a partnership between the American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery (ASCRS) to accelerate ophthalmic innovation through next-generation business conferences and platforms. Ocuphire is part of a lineup of more than 30 companies, from startups to public, who will present innovations at all stages. The format will be five-minute company presentations followed by a moderated Q+A with panels of seasoned pharma executive, investors, and KOLs. Ocuphire will be one of two companies presenting clinical data for Presbyopia at the meeting. For more details, please visit https://www.eyecelerator.com

    About Ocuphire Pharma

    Ocuphire is a publicly traded (NASDAQ:OCUP), clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for refractive and retinal 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® eye drops (0.75% phentolamine ophthalmic solution), 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 dim light or night vision disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, 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, a Phase 3 FDA registration study for treatment of RM. 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 www.clinicaltrials.gov 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, please visit www.ocuphire.com.  

    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 Nyxol plus LDP's potential to be a ‘best-in-class' presbyopia treatment option, the US and global market and commercial potential of Nyxol alone or in combination with LDP, and the expected timing of our future clinical trials in RM, NVD, presbyopia, and DR/DME. 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. 



    www.ocuphire.com 

    Corey Davis, Ph.D.

    LifeSci Advisors

     



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