Opus Genetics, Inc 8-K, filed Mar 15, 2021
Opus Genetics, Inc. (IRD)
8-K
2021-03-15
For: 2021-03-15
View Original
Added on
April 09, 2026
About this 8-K
Opus Genetics, Inc filed this 8-K on March 15, 2021.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 15, 2021
Ocuphire Pharma, Inc.
(Exact name of registrant as specified in its charter)
|
Delaware
|
001-34079
|
11-3516358
|
||
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
3700 Grand River Avenue, Suite 120
Farmington Hills, MI
|
48335
|
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Registrant’s telephone number, including area code: (248) 681-9815
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
Common Stock, $0.0001 par value
|
OCUP
|
Nasdaq Capital Market
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Sec.230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Sec.240.12b-2 of this chapter).
☐
Item 7.01 Regulation FD Disclosure.
On March 15, 2021, Ocuphire Pharma, Inc. (the “Company”) posted on its website an informational presentation regarding the results of its MIRA-2 Phase 3 registration trial for the reversal of mydriasis. A copy of the presentation is furnished
as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished, shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On March 15, 2021, the Company issued a press release regarding the results of its MIRA-2 Phase 3 registration trial for the reversal of mydriasis. A copy of the press release is filed as Exhibit 99.2 to this Current
Report on Form 8-K and incorporated herein by reference.
Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Current Report on Form 8-K, and the inclusion of such website addresses
in this Current Report on Form 8-K by incorporation by reference of the press release is as inactive textual references only.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit
|
||
|
Number
|
Exhibit Description
|
|
|
Investor Presentation Materials, dated March 15, 2021.
|
||
|
Press Release, dated March 15, 2021.
|
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
OCUPHIRE PHARMA, INC.
|
||
|
By:
|
/s/ Mina Sooch
|
|
|
Mina Sooch
|
||
|
Chief Executive Officer
|
||
Date: March 15, 2021
Exhibit 99.1
Exhibit 99.2
Ocuphire Announces MIRA-2 Phase 3 Registration Trial for
the Reversal of Mydriasis Meets Primary Endpoint
Nyxol Meets Its Primary and Multiple Secondary Endpoints Including Statistically Significant Efficacy Returning Subjects More
Rapidly to Normal Pupil Size Across a Breadth of Dilating Agents and Iris Colors
Nyxol has Potential to be a New Treatment Option for Reversal of Pharmacologically-Induced Pupil Dilation
Conference Call and Webcast Today @ 8:30am ET
Farmington Hills, Mich., March 15, 2021 - 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 positive top line results in the MIRA-2 Phase 3
registration trial investigating its product candidate Nyxol® for reversal of pharmacologically induced mydriasis (dilation of pupil for eye exams). Nyxol is a proprietary, preservative-free, stable, investigational eye drop formulation of
phentolamine mesylate designed to reduce pupil size by inhibiting contraction of the iris dilator muscle. MIRA-2 was designed as a multi-center, randomized, double-masked, placebo-controlled, parallel, 24-hour Phase 3 trial that planned 168 healthy
study participants, and ultimately enrolled 185 study participants.
These topline results indicate that the MIRA-2 trial met its primary endpoint with 49% percent of subjects (study eye) treated with Nyxol returning to ≤ 0.2
mm of their baseline pupil diameter at 90 minutes compared to 7% of subjects (study eye) treated with placebo (p <0.0001). The study population was comprised of subjects who had received one of three mydriatic (dilating) agents in the modified
Intent to Treat population (mITT). The three mydriatic agents used in this trial were phenylephrine 2.5% (alpha 1 agonist works on the iris dilator muscle), tropicamide 1% (cholinergic blocker works on the iris sphincter muscle), and Paremyd®
(a combination of hydroxyamphetamine hydrobromide 1% and tropicamide 0.25%), which are all commonly used in optometry and ophthalmology offices to dilate patients’ pupils for annual or special exams.
“The successful outcome of this Phase 3 MIRA-2 FDA registration trial is a major milestone for Ocuphire and we are thrilled to announce these positive and
clinically meaningful results. Nyxol showed a statistically significant improvement on the primary as well as multiple secondary endpoints, demonstrating its ability to more rapidly return pupil diameter back to normal baselines over multiple
timepoints, breadth of iris colors, and dilating agents that work on one or both iris muscles that control pupil size,” said Mina Sooch, MBA, President and CEO of Ocuphire Pharma. “These Phase 3 results build on a growing body of evidence to
establish Nyxol’s therapeutic product profile including the positive results seen in our recently published MIRA-1 Phase 2b trial. This further validates the mechanism of action, therapeutic effect, and safety profile of the Nyxol platform for
potential additional refractive indications - presbyopia and night vision disturbance. We are very grateful to the study participants and investigators who participated in this U.S. study.”
Highlights of MIRA-2 Topline Efficacy and Safety Results
MIRA-2 (NCT04620213) is a Phase 3 registration trial evaluating the product candidate Nyxol to expedite the reversal of pharmacologically induced mydriasis. In the trial 185 study participants (171 adults and 14 adolescents
at or over age 12) were randomized 1:1 to receive Nyxol (0.75% phentolamine ophthalmic solution) or vehicle control (placebo) 1 hour after receiving one of 3 mydriatic agents.
| • |
The primary endpoint was met with 49% percent of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter at 90 minutes compared
to 7% of placebo treated subjects (p <0.0001) across three mydriatic agents (phenylephrine, tropicamide, and Paremyd®).
|
| • |
Multiple secondary efficacy endpoints also met statistical significance.
|
| o |
A clinically meaningful higher number of Nyxol treated subjects (study eye and non-study eye) returned to baseline pupil diameter at 60 minutes compared to placebo,
and every subsequent timepoint through 6 hours post-dosing.
|
| o |
Nyxol treated subjects had mean pupil diameters that were 1 to 2.5 mm smaller than placebo treated subjects at all timepoints from 1 to 6 hours post-dosing.
|
| o |
Nyxol treated subjects returned to baseline pupil diameter more quickly than placebo treated subjects with:
|
(i) all three dilating agents;
(ii) both light and dark irides; and
(iii) with one and two drops of Nyxol.
| • |
Nyxol demonstrated a favorable safety profile.
|
| o |
Nyxol was well-tolerated in the study population with no serious adverse events or withdrawals due to adverse events.
|
| o |
A mild transient increase in conjunctival hyperemia was observed in Nyxol treated subjects which peaked at one hour post-dose and decreased steadily thereafter.
|
Jay S. Pepose, MD, PhD, Director of the Pepose Vision Institute, Professor of Clinical Ophthalmology at the Washington University School of Medicine, and
Ocuphire Medical Advisory Board member commented, “I am excited to see robust effects of Nyxol in reversing pharmacologically induced mydriasis with a favorable safety profile. The Phase 3 trial results exceeded my expectations with statistical and
clinical significance on the primary endpoint at 90 minutes, as well as at the earlier 60 minute timepoint. In addition, Nyxol demonstrated significant benefit through 6 hours across the range of commonly used mydriatic agents, light and dark iris colors, and age cohorts. Nyxol is unique as the only
alpha-1/2 antagonist in clinical trials. Nyxol has the potential to address an unmet medical need as there are no commercial treatments currently available for reversal of mydriasis. If approved for marketing by the FDA, Nyxol may provide
substantial benefit to patients after dilation, and may even increase the compliance with standard of care guidance for dilated examinations during visits to eye care
specialists and thereby improve overall eye health.”
A more detailed presentation of the topline MIRA-2 results will be discussed on a conference call this morning and posted shortly thereafter to the
Investors section of Ocuphire’s corporate website in the Events section. For more information about the MIRA-2 Phase 3 trial design and its 12 U.S. clinical sites, please visit www.clinicaltrials.gov (NCT04620213). Ocuphire
collaborated closely with Oculos Development Services, a Tampa, Florida based clinical research organization and subsidiary of Iuvo BioScience, on the execution of the MIRA-2 trial.
Building on the positive results of this first completed Phase 3 registration trial for Nyxol (MIRA-2), a second Phase 3 registration trial (MIRA-3) is
planned to initiate in the second half of this year. A New Drug Application (NDA) to obtain approval to market Nyxol for this pharmacologically induced mydriasis indication is expected to be submitted to the FDA in early 2023.
Full results from the MIRA-2 Phase 3 trial will be presented at an upcoming industry conference - 2021 ASCRS Annual Meeting July 23–27 in Las Vegas, Nevada.
Ocuphire also plans to submit these Phase 3 results to a peer-reviewed journal for publication later this year.
Reversal of Mydriasis Market Opportunity
Every year in the U.S., approximately 100 million eye exams are performed that require dilation of the pupil (mydriasis) to examine the back of the eye
either for routine check-ups, disease monitoring or surgical procedures. 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 with reading, working, and driving.
Market research conducted by GlobalData surveyed several hundred patients and eye care providers (optometrists and ophthalmologists) about Reversal of
Mydriasis (as well as Night Vision Disturbances and Presbyopia). Over 65% of surveyed patients reported moderate to severe negative impact of a dilated exam. This underscores the potential value of the role of the investigational product candidate
Nyxol in improving comfort and daily function after pupil dilation. Additionally, an estimated 45% of patients responded that they would be very likely to request a dilation reversal drop, and more than 40% of eye care providers would be likely to
use a reversal drop if such a treatment were commercially available.
Conference Call and Webcast (with slides)
Ocuphire management will host a conference call and webcast with slides, today at 8.30am ET. Details for the call are as follows:
|
Toll free (U.S.)
|
877-407-4018
|
|
International:
|
201-689-8471
|
|
Conference ID
|
13717533
|
|
Webcast:
|
http://public.viavid.com/index.php?id=143904
|
The webcast will also be available on the “Investors” tab of the Ocuphire corporate website tab, under News & Events and will be archived for 90 days.
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 dim light or night vision
disturbances (NVD), reversal of pharmacologically-induced mydriasis (RM), and presbyopia, and has been studied in 8 clinical trials including the recently completed Phase 3 trial in RM. Nyxol is also currently in Phase 3 clinical development for
NVD and in Phase 2 for presbyopia. 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 entering Phase 2 clinical development for 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 (NCT04620213),
ongoing Phase 3 registration trial (NCT04638660) and Phase 2 trial in presbyopia (NCT04675151), and soon to recruit 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 Ocuphire’s product candidates,
results of ongoing and future clinical trials, and commercialization and market opportunities. 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; (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, and (ix) the success and timing of commercialization of any of Ocuphire’s product candidates. 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
www.ocuphire.com
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com