RVLP RVL Pharmaceuticals PLC

 RVL Pharmaceuticals, Inc. (“RVL” or the “Company”), a specialty pharmaceutical company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired blepharoptosis, or droopy eyelids, in adults, today announced that it and its wholly-owned U.S. operating subsidiary RVL Pharmacy, LLC (collectively, the “RVL Subsidiaries”), successfully emerged from their Chapter 11 cases on November 22, 2023 following the confirmation by the United States Bankruptcy Court for the District of Delaware of their Plan of Reorganization (“Plan”) on November 20, 2023. RevitaLid Pharmaceutical Corp., previously the direct parent company of RVL Pharmaceuticals, Inc, concurrently emerged from its Chapter 11 case, though will be wound down under the Plan.

“Upon emergence, the RVL Subsidiaries are well-positioned to invest in UPNEEQ, drive their strategic initiatives, and continue to deliver high-quality, innovative ocular and aesthetic solutions for patients and healthcare partners,” said Brian Markison, Chief Executive Officer of the Company.

The Plan was unanimously supported by the RVL Subsidiaries’ sole secured lender (funds managed by Athyrium Capital Management, LP (“Athyrium”)) and other key stakeholders. The Company will continue to operate and be supported as a privately held company under the ownership of Athyrium.

It is expected the wind-down of the Company’s former public parent company, RVL Pharmaceuticals plc, and its subsidiaries other than the RVL Subsidiaries will promptly commence, and RVL Pharmaceuticals plc’s public equity is expected to be cancelled upon completion of its wind-down during 2024, resulting in no recovery to public shareholders.

About the Company

RVL Pharmaceuticals, Inc. 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. For more information, please visit the Company’s website at www.rvlpharma.com.

IMPORTANT SAFETY INFORMATION

INDICATION

UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, is indicated for the treatment of acquired blepharoptosis in adults.

WARNINGS AND PRECAUTIONS

• Ptosis Association: Ptosis may be associated with neurologic or orbital diseases such as stroke, cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection, and orbital masses. Consider these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
• Cardiovascular Impact: Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
• Use with Caution: Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
• Glaucoma Risk: UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
• Container Safety: Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.

ADVERSE REACTIONS

Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ include punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation, and headache.

DRUG INTERACTIONS

• Blood Pressure: Alpha-adrenergic agonists, as a class, may impact blood pressure. Exercise caution when using drugs such as beta-blockers, anti-hypertensives, and/or cardiac glycosides.
• Metabolism: Caution is advised in patients taking monoamine oxidase inhibitors, which can affect the metabolism and uptake of circulating amines.

For inquiries, please contact:

Brian Markisonbrianmarkison@rvlpharma.com