Brooke Beery, Associate Editor

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Osmotica Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval of Upneeq (oxymetazoline hydrochloride ophthalmic solution), 0.1%, the only FDA-approved medical treatment for Ptosis, which occurs when one or both upper eyelids sag. Ptosis often stems from a partial or complete dysfunction of Müller’s muscle, which lifts the eyelid, according to the company. In severe cases, the condition can limit field of vision.

Related: Vision Expo West 2020 cancelled due to COVID-19

Upneeq, formerly known as RVL-1201, is a non-surgical option to treat ptosis patients that relies on a once-daily topical ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist.

clinical studies conducted for FDA approval

, the drug showed clinically significant improvements in ptosis patients when compared to placebo in both superior visual field, as measured by the Leicester Peripheral Field Test (LPFT), and eyelid lift, as measured by the Marginal Reflex Distance Test (MRD-1) in 2 pivotal double-masked efficacy studies. A third pivotal study positively demonstrated that Upneeq was well tolerated when administered once daily, in the morning, to both eyes, over a 12-week period.

Related: 5 common ocular problems seen during the pandemic

The bulk of adverse reactions observed were:

As the only FDA approved drug for ptosis, Osmotica’s market share of Upneeq is currently uncapped, 

. Osmotica is planning to sell Upneeq commercially as soon as next month as a 0.3 mL single patient-use container in 15- and 30-count cartons. The company is working with partners outside of the U.S to begin international distribution. 

Related: NIH launches clinical trials network: COVID-19 vaccine underway

Articles

Once-a-day treatment offers patients a solution to droopy eyelids

Ptosis therapy gets first-in-category FDA nod

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institute of Health (NIH), established a network of clinical trials in hopes of enrolling thousands of volunteers to participate in early COVID-19 vaccine testing.

Related: Headache a key symptom of COVID-19

 has set up a secure method of volunteering for local studies. Anyone over the age of 18 may participate. If chosen, participants will be subjected to injections or infusions containing the study product or a placebo. Most studies require traveling to the research site for 10 or more visits over a span of 1 to 2 years.

The COVID-19 Prevention Trials Network (COVPN) consists of 4 existing NIAID-funded clinical trials networks including:

Infectious Diseases Clinical Research Consortium

Related: COVID-19 antibodies can disappear in non-symptomatic individuals

Together, they create a functional unit of “Operation Warp Speed,” an initiative led by the U.S. Department of Health and Human Services (HHS) to organize the development and distribution of COVID-19 diagnostics, therapeutics, and vaccines.

“Establishing a unified clinical trial network is a key element of President Trump’s Operation Warp Speed, which aims to deliver substantial quantities of a safe, effective vaccine by January 2021,” says Alex Azar, HHS Secretary, in a statement.

“Starting this summer, this new network will leverage existing infrastructure and engage communities to secure the thousands of volunteers needed for late-stage clinical trials of promising vaccines,” he says.

Related: Telemedicine in the face of COVID-19

The network is projected to operate more than 100 clinical trial sites throughout the United States and the world.

Interested persons can learn more about the different stages of vaccine research and the new network’s COVID-19 vaccine and monoclonal antibody studies by visiting 

https://www.coronaviruspreventionnetwork.org

Thousands of participants needed for research.

NIH launches clinical trials network: COVID-19 vaccine underway

Vision Expo organizers, The Vision Council and Reed Exhibitions, announced the cancellation of the optometric conference Vision Expo West 2020 previously scheduled to take place in Las Vegas from September 23-26.

The decision comes after Vision Expo East and the American Optometric Association’s (AOA) Optometry’s Meeting 2020 were cancelled in March and June, respectively. Meeting organizers cite health and safety concerns as the main reason for the cancellation. Nevada Governor Steve Sisolak (D)announced Monday, June 26, that Nevada would remain in Phase 2 of reopening plans through the end of July due to current trends of the coronavirus infection.

Related: Safe & effective ocular triage in the COVID-19 era

“While certainly disappointing, the decision to cancel Vision Expo West 2020 is prudent and necessary following the announcement of the extension of Phase 2 in Las Vegas into the end of July,” says Fran Penella, event vice president, in a statement.

“Without having visibility on when the state of Nevada will be ready to roll into future phases or what the future phases will allow for, coupled with the unfortunate spiking of COVID-19 cases in the region, we know it is in the best interests of everyone in the vision community to not move forward.”

Attendees and exhibitors who had previously registered for the event may still take part in a digital platform that will virtually replace in-person experiences. Continuing education (CE) product showcases, and service and product sourcing will take place on the new platform.

More details on specific offerings and partners will be forthcoming, and personalized communications will be sent to each registered attendee this week from the Vision Expo team.

Related: AOA elects '20-'21 officer slate via virtual ballot

Vision Expo West 2020 cancelled due to COVID-19

Connor Christensen from the University of Houston College of Optometry won top honors in Essilor’s 29th annual Optometry Student Bowl (OSB), which kicked off its game-show style tradition in 1992.

The competition takes place during the American Optometric Association’s Optometry’s Meeting every June. Due to COVID-19, this year’s in person-meeting was cancelled, resulting in the competition’s first ever virtual experience.

Over 1500 attendees tuned in to watch contestants, including students from 25 schools and colleges of optometry, buzz in with correct answers to optometry-related questions.

The winning school walked away with $1000, diagnostic lenses from Volk, the Ventura Cup, and a lifetime of bragging rights. The second-place winner, Alec Waters from Southern College of Optometry, received $750, and third-place winner, Katelyn Flood from University of Missouri St. Louis College of Optometry, received $500.

Each contestant collected a Volk Ran Retinal 2.2 blue-ringed lens, courtesy of Volk. In addition, Keeler provided every participant with a personal protective equipment (PPE) kit.

In addition to the main prizes, the Zoom Background Award went to The New England College of Optometry. The school will help produce next year’s competition’s “hype video” to kick off the competition.

A social media-based Virtual Spirit Award was awarded to The Massachusetts College of Pharmacy and Health Sciences School of Optometry for innovative social media posts during the event.

This year’s panel of expert judges included:

Lead Judge - Linda Casser, OD, FAAO, professor, Pennsylvania College of Optometry at Salus University

Diane Adamczyk, OD, professor at State University of New York College of Optometry.

Bob Layman, OD, President-Elect of the AOA

Dr. Sue Oleszewski, MD, retired professor emerita from Pennsylvania College of Optometry at Salus University

Related: J&J Vision receives FDA clearance for astigmatism management software

Some 25 schools competed virtually for Ventura Cup.

Author | Brooke Beery, Associate Editor

Articles

Ptosis therapy gets first-in-category FDA nod

NIH launches clinical trials network: COVID-19 vaccine underway

Vision Expo West 2020 cancelled due to COVID-19

29th annual Optometry Student Bowl held virtually in 2020