RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL” or the “Company”) announced today that its prescription eye drop Upneeq® (oxymetazoline hydrochloride ophthalmic solution), 0.1% has been selected the winner in the professional treatment category as “Best Eye Drop for Drooping Lids” in the NewBeauty 13th Annual Beauty Awards. Upneeq is FDA approved for the treatment of acquired blepharoptosis (droopy eyelids) in adults. It is the second consecutive win for the brand. Upneeq® was awarded the “Best Innovation” in 2022 by this definitive authority in beauty. The 13th Annual NewBeauty Awards issue hits newsstands on April 4, 2023.
Over 10,000 products were submitted for the 2023 awards with 399 selected. Each winning product was proven to both effectively solve an aesthetic concern and meet rigorous testing standards by the NewBeauty editorial team along with an independent panel of key opinion leaders, top medical and industry professionals as well as advisors.
According to NewBeauty Features Editor, Tatiana Bido “Upneeq couldn’t be any easier to use.” She also called it an instant eyelid-lifter for ptosis or low-lying lids during their testing process.
“Upneeq has proven to be a gamechanger in our field,” said Dr. Raymond Douglas, M.D., PhD, a board-certified Aesthetic Reconstructive and Oculoplastic Specialist and Global Head of Scientific Affairs for RVL Pharmaceuticals. “It can work in one or both ptotic eyes in as little as five minutes giving the eyes a more open looking appearance. With the drop we see an average eyelid elevation between 1 and 2 millimeters which is truly significant.”
“We are incredibly proud to be acknowledged for a second year by NewBeauty with this prestigious award,” said Brian Markison, Chief Executive Officer of RVL Pharmaceuticals. “We are building a new market where Upneeq has been an exciting innovation for eyelids – as the first Rx treatment for low-lying lids in adults. As we continue to build the brand in the medical aesthetics field, this recognition from the industry’s leading authority is compelling and beneficial validation.”
Upneeq® received FDA approval in July 2020 and was introduced as the only non-surgical therapeutic approved for acquired ptosis (low-lying lids) in adults. First-in-class, Upneeq® is a safe and effective, fast acting, daily treatment for patients at eye care and medical aesthetic practices nationally.
In clinical trials, Upneeq® demonstrated statistically significant improvements compared to placebo in both superior visual field and eyelid lift, as measured in two pivotal double-masked efficacy studies. The most common adverse reactions with Upneeq (occurring in 1-5% of patients) were eye inflammation, eye redness, dry eye, blurred vision, eye pain at time of use, eye irritation, and headache. For more information and for the complete Important Safety Information, visit www.upneeq.com
IMPORTANT SAFETY INFORMATION
What is UPNEEQ?
UPNEEQ ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is a prescription eyedrop used to treat acquired blepharoptosis (low-lying lids) in adults.
What warnings and precautions are associated with UPNEEQ?
- Low-lying lids may be related to conditions such as stroke and/or brain aneurysm, Horner syndrome, myasthenia gravis, loss of the ability to move eye muscles, eye infection and eye tumors. Tell your doctor if you have any of these conditions.
- UPNEEQ is a type of medication that may affect your blood pressure. If you have heart disease, uncontrolled high or low blood pressure, or feel faint at rest or when quickly standing up, you should call your doctor if your symptoms get worse.
- Patients with reduced blood flow to the brain or heart, or patients who experience eye or mouth dryness due to an immune system disorder (Sjögren’s syndrome), should use care when taking UPNEEQ. Call your doctor immediately if you feel your symptoms may be getting worse.
- UPNEEQ may increase the risk of eye pressure due to fluid buildup (angle-closure glaucoma) in patients with untreated narrow-angle glaucoma. Call your doctor immediately if you feel increased pressure in your eye after using UPNEEQ.
- Do not let the tip of the UPNEEQ vial touch your eye or any other surface. This can help prevent eye injury or contamination. Each UPNEEQ vial is for one-time use and should be discarded after being used.
What are the most common side effects of UPNEEQ?
- The most common adverse reactions with UPNEEQ (occurring in 1-5% of patients) were eye inflammation, eye redness, dry eye, blurred vision, eye pain at time of use, eye irritation, and headache.
What should my doctor know about before prescribing me UPNEEQ?
- Your doctor should review your full medical history before prescribing UPNEEQ.
- UPNEEQ belongs to a class of medication (alpha-adrenergic agonists) that may affect your blood pressure. Use UPNEEQ carefully if you currently take an alpha-adrenergic agonist medication to treat heart disease or an enlarged prostate. Patients taking beta-blockers, or other medications to treat hypertension or an abnormal heartbeat, should also be careful when using UPNEEQ.
- Patients who use a certain class of antidepressant medication (monoamine oxidase inhibitors) should also be careful when using UPNEEQ, as it may affect the way your body absorbs the medication.
These are not all of the possible side effects of UPNEEQ. Tell your doctor if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects.
To report side effects or product complaints, contact RVL Pharmaceuticals at 1-877-482-3788. You may also report side effects to the FDA by calling 1-800-FDA-1088 or visit www.fda.gov/medwatch.
This is a summary of the most important safety information for UPNEEQ. For more in-depth safety information, please review the full Prescribing Information for UPNEEQ.
Forward Looking Statements
This press release includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “targets,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, its results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of UPNEEQ, FDA and other regulatory applications, approvals and actions, our plans to launch a new eCommerce platform, the continuation of historical trends, our ability to manage costs and service our debt and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: UPNEEQ’s ability to reach market acceptance by clinicians and patients; our ability to successfully commercialize UPNEEQ; our customers’ willingness to pay the price we charge for UPNEEQ; the results of our marketing and sales expenditures; our dependence on third-party suppliers and distributors for UPNEEQ; UPNEEQ’s ability to produce its intended effects; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; and other risks and uncertainties more fully described in the “Risk Factors” section of our Annual Report on Form 10-K filed on March 20, 2023, and other filings that the Company makes with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.
About RVL Pharmaceuticals plc
RVL Pharmaceuticals plc is a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or low-lying eyelid, in adults. UPNEEQ is the first non-surgical treatment option approved by the FDA for acquired blepharoptosis.
About NewBeauty / NewBeauty Awards
The highly regarded industry and consumer publication, NewBeauty is published by Sandow Media. NewBeauty is the ultimate resource redefining the beauty space with its trend-driven approach to content combining authoritative experts, education and advances in industry innovation. Filled with NewBeauty editors’ trusted voices, the magazine provides an in-depth and comprehensive look at new products and breakthrough technologies with a split reputation of scientifically accurate expert-driven original reporting with ethically balanced editorial resources. NewBeauty offers a highly- curated group of winners in the annual NewBeauty Awards. Product winners of the NewBeauty Awards Seal must effectively deliver on their claims, solve aesthetic concerns, and fulfill the rigorous testing process of editors and experts.
Investor and Media Relations for RVL Pharmaceuticals plc
Lisa M. Wilson
In-Site Communications, Inc.