Ptosis

UPNEEQ® Wins "Best in Innovation" Award from New Beauty

Retrieved on: 
Wednesday, April 6, 2022
Duane syndrome, Company, Ophthalmoparesis, Orthostatic hypotension, Risk, Blepharoplasty, Metabolism, Headache, Blood pressure, U.S. FDA, EVP, Myasthenia gravis, Glaucoma, Glycosidic bond, Patient, Aneurysm, Focal neurologic signs, Cardiovascular disease, Hypertension, Industry, Stroke, Oxymetazoline, Beta blocker, Nasdaq, Ptosis, Mark (given name), Horner's syndrome, Xanthine oxidase inhibitor, Orbit, Hypotension, FDA, Education, Eye, Eye injury, Pharmaceutical industry, Phosphorus, Leptodeira

BRIDGEWATER, N.J. , April 6, 2022 /PRNewswire/ -- RVL Pharmaceuticals plc (Nasdaq: RVLP) announced today that its U.S. FDA approved acquired blepharoptosis (ptosis) drug UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% has been selected as the winner of a "Best  in Innovation" award in the 12th Annual Beauty Awards conducted by New Beauty, a Sandow Publication.

Key Points: 
  • New Beauty, a trend-driven education-powered quarterly published resource and website, has been a leader in the aesthetic space since its launch in 2005.
  • New Beauty Features Editor, Tatiana Bido, said of the non-surgical option to treat adults with acquired ptosis, "UPNEEQ is an instant eye-lifter for adults with acquired ptosis or low-lying eyelids.
  • "We are thrilled to be acknowledged by New Beauty with an Innovation Award for UPNEEQ," said JD Schaub, EVP & Chief Operating Officer.
  • Industry support and validation like this award from New Beauty is further proof of concept."

Osmotica Pharmaceuticals plc Announces Corporate Name Change to RVL Pharmaceuticals plc, New Ticker Symbol “RVLP,” Plans to Launch UPNEEQ® into the Medical Aesthetics Market, and Provides Fourth Quarter 2022 Net Sales Guidance

Retrieved on: 
Wednesday, January 19, 2022
Beta blocker, Webcast, Nature, Face, Patient, Xanthine oxidase inhibitor, Orbit, Eye, Stroke, Focal neurologic signs, Myasthenia gravis, Duane syndrome, Pharmacy, Ptosis, Orthostatic hypotension, Intellectual property, Metabolism, Headache, U.S. Securities and Exchange Commission, Hypertension, Glycosidic bond, Blood pressure, Cardiovascular disease, Company, Ophthalmoparesis, Horner's syndrome, Blepharoplasty, Eye injury, Mark (given name), Hypotension, Risk, Glaucoma, FDA, Mission statement, Security (finance), Terminology, Aneurysm, Phosphorus, Pharmaceutical industry

BRIDGEWATER, N.J., Jan. 19, 2022 (GLOBE NEWSWIRE) -- Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“OSMT” or the “Company”), a specialty pharmaceutical company, announced today that the Company has changed its name to RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL”). This rebranding reflects RVL’s strategy to become a growth company in eye care and medical aesthetics, and, as part of this transformation, RVL has launched a new corporate website www.rvlpharma.com.

Key Points: 
  • The financial and operating data for the fourth quarter of 2021 is preliminary and may change.
  • Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • RVL Pharmaceuticals plc is a specialty pharmaceutical company focused on the commercialization and development of products that target markets with underserved patient populations in the ocular and medical aesthetics therapeutic areas.
  • The Company is currently commercializing UPNEEQ (oxymetazoline hydrocholoride ophthalmic solution, 0.1%), for the treatment of acquired blepharoptosis, or low-lying eyelid, in adults.

U.S. FDA Approves New MENTOR® MemoryGel BOOST™ Breast Implant

Retrieved on: 
Thursday, January 13, 2022
Johnson & Johnson, Patient, Surgeon, Degenerative disease, Safety, Lymphoma, Wound healing, Incidence, Private Securities Litigation Reform Act, Regulation of tobacco by the U.S. Food and Drug Administration, Medical device, Lupus, Milk, Breast implant, Risk, Ptosis, Breast, Mentorship, U.S. Securities and Exchange Commission, Breast augmentation, Myalgia, Goal, Confusion, MENTOR, Arthralgia, Diagnosis, Quality of life, MRI, Depression, Sale, Chronic fatigue, Cancer, Food, Immune system, Scleroderma, Behavior, Annual report, FDA, Security (finance), Rupture, Woman, Birth control, Dentistry, Borosilicate glass, Tutoring, Pharmaceutical industry

"The MemoryGel BOOST Breast Implant is truly a unique innovation that satisfies an unmet need and expands the MemoryGel product line."

Key Points: 
  • "The MemoryGel BOOST Breast Implant is truly a unique innovation that satisfies an unmet need and expands the MemoryGel product line."
  • This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding MENTOR MemoryGel BOOST Breast Implant.
  • The MENTORCollection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR MemoryGel Breast Implants or MENTOR MemoryShape Breast Implants, and at least 18 years old for MENTOR Saline Breast Implants, and breast reconstruction.
  • For MemoryShape Implants: Patient Educational Brochure Breast Augmentation with MENTOR MemoryShape Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR MemoryShape Breast Implants.

The Box by Dr Ava Announces Fabulous Fall Skincare Line-up

Retrieved on: 
Monday, October 25, 2021
Dark, Woman, Elasticity, Breast cancer, Collagen, Hair follicle, Susan, Allure, SPF, Hyaluronic acid, Patient, The Box, Newuniversal, Cosmo, FDA, Weather, Spirituality, Beauty, Ptosis, Box, Vitamin C, Facebook, Multimedia, Skin, Irritation, Bazaar, Hair, Health, Serum, Cosmetics, Television

LOS ANGELES, Oct. 25, 2021 /PRNewswire/ -- The Box by Dr Ava , the only dermatologist-curated, subscription skincare box, today announces its highly anticipated Fall 2021 Skincare Box.

Key Points: 
  • LOS ANGELES, Oct. 25, 2021 /PRNewswire/ -- The Box by Dr Ava , the only dermatologist-curated, subscription skincare box, today announces its highly anticipated Fall 2021 Skincare Box.
  • Professionally-developed and approved, The Box by Dr Ava Fall Skincare offerings are tried and tested by Beverly Hills celebrity dermatologist Dr Shamban, passing her extremely high standards for efficacy, results and professional grade ingredients.
  • Built upon her '5 Beauty Pillars' philosophy, The Box by Dr Ava features products and treatments that fulfill Dr Ava's foundations for true beauty.Those include skincare, nutrition, fitness, spirituality and connection.
  • The Box by Dr Ava Fall Skincare Box includes:
    Alastin HydraTint ProMineral Sunscreen SPF 36 - "I include a SPF in every single box.

Osmotica Pharmaceuticals plc Announces Debt Financing from Athyrium Capital Management of up to $100 Million

Retrieved on: 
Thursday, October 7, 2021
Company, Intellectual property, Patient, Headache, LP, Risk, Eye injury, Ptosis, Orbit, Aneurysm, Horner's syndrome, Duane syndrome, Metabolism, Myasthenia gravis, Orthostatic hypotension, Xanthine oxidase inhibitor, GLOBE, Terminology, Hypotension, U.S. Securities and Exchange Commission, Focal neurologic signs, Mark (given name), Nature, Blepharoplasty, Security (finance), Blood pressure, Stroke, Ophthalmoparesis, Glaucoma, Achievement, Hypertension, Face, Solution, Eye, Cardiovascular disease, Nasdaq, Glycosidic bond, Pharmaceutical industry, Financial services, Phosphorus

We are thrilled to partner with the Osmotica team and to provide capital to support the commercial efforts around Upneeq, said Mark Kavulich, Partner, Athyrium Capital Management.

Key Points: 
  • We are thrilled to partner with the Osmotica team and to provide capital to support the commercial efforts around Upneeq, said Mark Kavulich, Partner, Athyrium Capital Management.
  • Subject to the satisfaction of certain conditions, at closing of the agreement, Osmotica will issue $55 million of senior secured notes.
  • An additional $20 million of notes will be available to Osmotica at its option by October 2022 subject to the achievement of minimum Upneeq revenues.
  • Athyrium Capital Management, LP is a specialized asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector.

Galderma Announces Top-line Results from Phase 2 Clinical Dose-Escalating Study with Azzalure® / Dysport® (abobotulinumtoxinA)

Retrieved on: 
Tuesday, November 17, 2020
Health, Surgery, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Clinical trials, Anatomy, Branches of biology, Drugs, Botulinum toxin, Botulism, Neurotoxins, Placebo-controlled study, Dose-ranging study, Ptosis, Eyelid

At all doses tested in the trial, Dysport had a strong safety profile, including very few cases of eyelid ptosis.

Key Points: 
  • At all doses tested in the trial, Dysport had a strong safety profile, including very few cases of eyelid ptosis.
  • The multicenter, randomized, dose-ranging, double-blind, placebo-controlled Phase 2 study enrolled 401 subjects ages 18 to 65 with moderate to severe glabellar lines at maximum frown.
  • Favorable results were achieved for all doses in the secondary objectives, including a 1-grade improvement and subject satisfaction throughout the study duration.
  • This phase 2 study underscores our commitment to bring efficacious products and long-lasting results to customers, said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma.

JAMA Ophthalmology Publishes Pooled Analysis of Data from two Phase 3 Clinical Trials of Upneeq™ (oxymetazoline hydrochloride, 0.1% solution) for Acquired Ptosis

Retrieved on: 
Thursday, October 1, 2020
Anatomy, Ophthalmology, Ptosis, Eyelid, Levator palpebrae superioris muscle, Ptosis crutches

Ptosis is an abnormal drooping of the upper eyelid margin with the eye in primary gaze1.

Key Points: 
  • Ptosis is an abnormal drooping of the upper eyelid margin with the eye in primary gaze1.
  • These trials represent a meaningful step in our evolution to an innovation-focused specialty pharmaceutical company.
  • In these clinical trials, we saw statistically significant improvements in the ptosis-induced superior visual field defects and drooping upper eyelid positions.
  • It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis.

Santen and RVL Pharmaceuticals, Inc., an Osmotica Company, Enter into an Exclusive License Agreement in Japan, Asia, and EMEA for RVL-1201, a First-in-Class Treatment for Acquired Blepharoptosis

Retrieved on: 
Tuesday, July 28, 2020
Ptosis

Santen will be responsible for further development of RVL-1201 and regulatory approvals as well as commercialization in its licensed territories under the agreement.

Key Points: 
  • Santen will be responsible for further development of RVL-1201 and regulatory approvals as well as commercialization in its licensed territories under the agreement.
  • The companies believe that there are no approved pharmacologic treatments for acquired ptosis anywhere outside the United States.
  • As a specialized ophthalmic company, we are very pleased to be entering into this license agreement with Osmotica.
  • We hope that our agreement with Osmotica enables us to serve to peoples eyecare.

Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for Acquired Blepharoptosis (Droopy Eyelid) in Adults

Retrieved on: 
Thursday, July 9, 2020
Clinical research, Design of experiments, Ptosis, Placebo-controlled study, Health, Medicine

One study comprising adults over the age of 50 indicates prevalence of ptosis is ~11.5% of adult patients over the age of 501.

Key Points: 
  • One study comprising adults over the age of 50 indicates prevalence of ptosis is ~11.5% of adult patients over the age of 501.
  • With the approval of Upneeq, eye care specialists now have a safe and convenient non-surgical option to treat their patients who have ptosis.
  • The 2:1 randomized, double-masked, placebo-controlled study was comprised of 140 patients with acquired blepharoptosis split into two treatment groups for 42 days.
  • The Company also completed a 12-week randomized, multicenter, double-masked, placebo controlled safety study to evaluate the safety of Upneeq compared with vehicle for the treatment of acquired blepharoptosis.

Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Acceptance of New Drug Application by FDA for RVL-1201 (Oxymetazoline Hydrochloride Ophthalmic Solution, 0.1%) for Acquired Blepharoptosis (Droopy Eyelid)

Retrieved on: 
Wednesday, November 20, 2019
Ptosis, Eyelid

With the simplicity of using a once-daily eye drop, RVL has the potential to transform the clinical treatment of acquired blepharoptosis, said Brian Markison, Osmoticas Chief Executive Officer.

Key Points: 
  • With the simplicity of using a once-daily eye drop, RVL has the potential to transform the clinical treatment of acquired blepharoptosis, said Brian Markison, Osmoticas Chief Executive Officer.
  • It can generally be classified as congenital or acquired, with the most common type being age-related aponeurotic ptosis.
  • If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelid.
  • Vertical Pharmaceuticals, LLC represents the Companys diversified branded portfolio, and Trigen Laboratories, LLC represents the non-promoted products including complex generic formulations.