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Alcon’s Pataday Eye Allergy Meds Get FDA Nod for Nonprescription Use

They’ll no longer be sold as prescription drugs.

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The U.S. Food and Drug Administration has approved two Alcon eye allergy products for over-the-counter use through a process called a “prescription (Rx)-to-OTC switch.”

The FDA gave the OK to these medications for nonprescription use:

  • Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander.
  • Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander.

“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

For a drug to switch to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

Pataday Twice Daily Relief was first approved by the FDA in 1996 under the name Patanol as a prescription drug and was indicated for the treatment of the signs and symptoms of allergic conjunctivitis (referring to ocular redness and itching due to allergies). Pataday – now Pataday Once Daily Relief – was first approved by the FDA in 2004 as a prescription drug and was indicated for the treatment of ocular itching associated with allergic conjunctivitis. These drugs are mast cell stabilizers, which work by preventing the release of histamine and therefore prevent or control allergic disorders.

The products will be marketed in the U.S. as nonprescription drugs and will no longer be available as prescription drugs.

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Sight Sciences Completes $30M Financing Round

It’s working on technology for glaucoma and dry eye disease.

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MENLO PARK, CA — Sight Sciences Inc., a medical device company working on technology for treatment of glaucoma and dry eye disease, announced the closing of an over $30 million financing round.

Proceeds will be used for continued clinical and operational development and to support commercial expansion for Sight Sciences’ OMNI and TearCare products, according to a press release. The Series E preferred stock round was led by D1 Capital Partners.

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“Sight Sciences has introduced two technologies that have fundamentally improved how physicians can treat two of the most prevalent eye diseases. In minimally invasive glaucoma surgery the safety, efficacy and versatility of the OMNI device is unmatched,” said  James Rogers, analyst at D1 Capital Partners. “Additionally, we feel the early success with the commercialization of TearCare suggests this innovative and effective solution has addressed the shortfalls of previous dry eye treatments and modalities for this common ailment.”

Glaucoma affects 80 million people globally and is the leading cause of irreversible blindness in the aging world population. Dry eye disease afflicts 350 million people globally and is the leading cause of visits to an eyecare provider.

“We are thrilled to be closing a significant growth investment round with D1,” said Jesse Selnick, CFO of Sight Sciences. “D1 is truly a perfect fit for our company at this stage, combining the scale, market reach, investment talent and operational acumen of a large, premier asset manager with the flexible mandate and long-term investment horizon of a family office.”

Founded by Daniel Sundheim in 2018, D1 currently has $10 billion of capital under management and invests in the global internet, technology, telecom, media, consumer, healthcare, industrial and real estate sectors. Sight Sciences represents the third late-stage private healthcare investment made by D1 in the last 18 months.

“We are extremely excited to partner with D1 over the long term,” said Paul Badawi, founder and CEO of Sight Sciences. “This investment further validates the substantial progress we have made in our mission to transform the treatment of the world’s most prevalent eye diseases.  Through further clinical trials and continued scale-up of our commercial infrastructure, we are looking forward to accelerating the market development of both standalone MIGS with OMNI and procedure-based dry eye therapy with TearCare.”

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COVID-19 Resource Center for ECPs

Find advice on how to apply for benefits and tax breaks, communication toolkits, FAQs about your obligations as an employer, databases, disease trackers and more.

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COVID-2019

THREE SEPARATE PACKAGES approved by Congress over the past few weeks represent a more than $2-trillion dollar effort by the federal government to help Americans — and in some cases, small business owners specifically — deal with the impact of the COVID-19 pandemic. As massive as that relief package is, it represents only a part of the assistance that’s available. Below are links to a wealth of resources from government, industry, corporate and community organizations that will help you deal with this unprecedented challenge. The list includes advice on how to apply for benefits and tax breaks, communication toolkits, FAQs about your obligations as an employer, databases, disease trackers and more. We’ll continue to update the list over the coming weeks. If you come across a great resource yourself or have an experience to share about applying for federal or other assistance, please let us know. We’re all in this together.

Places to Start

The U.S. Chamber of Commerce has an excellent breakdown of all the federal programs and aid for small business coronavirus assistance here.

The AOA offers guidance and updates to doctors of optometry at its dedicated coronavirus page.

Justworks.com, an HR solutions company, provides advice on applying for tax refunds, employee leave and other obligations, working-from-home tips along with a handy FAQ section.

Federal

Much of the assistance to small businesses is being channeled through the U.S. Small Business Administration (SBA), which has a coronavirus resource page listing special loans, relief programs and the other assistance that is available to small business owners. You can find guidance on the loans here.

Meanwhile, the actual loan application page is here.

Need help interpreting the forms? SCORE, the volunteer business advice group, is offering assistance in filling out the SBA loan applications as well as running workshops and provding remote mentoring.

Taxes

To ease the strain on businesses, the federal tax return filing deadline has been pushed back to July 15, with businesses allowed to defer up to $10 million in payments, interest free. The IRS has provided details here.

There are also many tax breaks and credits available for employers who keep staff on or provide paid leave to sick workers or those looking after sick family members. More information on those tax changes can be found here.

Several states have already aligned their tax filing and payment deadlines with the new federal deadline. You can find out whether your business has more time to file or more time to pay state and local taxes this year as a result of the coronavirus here.

A list of similar initiatives in various states is available from the American Institute of Certified Public Accountants.

Corporate

Facebook has pledged to give up to 30,000 small businesses a total of $100 million in cash grants and Facebook advertising credits.

If you have team-members working remotely, Microsoft Teams is now free for use. The program includes a chat feature, video calling, 10 GB of storage for the entire team, 2 GB storage in a personal file plus various Office apps.

Many newspapers, including the Wall Street Journal, the Washington Post and The New York Times have dropped their firewalls for coronavirus coverage. The Times’ dedicated section offers the latest news on the virus and features on topics such as layoffs and reduced hours as well as more general health FAQs.

An unemployment benefits finder is available here.

Specific Industry Resources

The Vision Council has assembled a “Coronavirus Implications” page with resources for eyecare professionals, including a state-by-state list to help determine which businesses can remain open and which must be closed during the COVID-19 crisis.

Tools

To help you manage your business through the coronavirus crisis, the U.S. Chamber of Commerce has created a toolkit for businesses and a customizable flyer for businesses to communicate their coronavirus efforts to customers.

Assess the potential impact to your business and gauge your readiness to respond with this COVID-19 Navigator from PwC.

Facebook is also offering a Resilience Toolkit “to help you prepare for disaster” and a Quick Action Guide to help you plan your emergency response and minimize downtime.

General

The U.S. Centers for Disease Control and Prevention is one of the best sources for accurate coronavirus information, with material available on infections in a business setting (how to implement social distancing, for example), printable hygiene posters and more resources for businesses and employees. The main page is here.

Need information on state or territorial health department? Here is a link to health departments in all 50 states, eight U.S. territories and freely associated states, and the District of Columbia.

The World Health Organization (WHO) has a plethora of information available, including reliable and up-to-date news on the coronavirus, travel advice, and an interactive COVID-19 dashboard.

The Labor Department’s Occupational Safety and Health Administration (OSHA) has issued guidance on on Preparing Workplaces for COVID-19 that you can download here.

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COVID-19 Relief for Optometrists: AOA Announces Coronavirus Package for ECPs

It’s valued at $5.5M.

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The American Optometric Association announced a $5.5 million crisis relief and recovery assistance package for eyecare providers.

The actions, outlined in a letter to AOA members, “come as the AOA continues to fight 24/7 for optometry in Washington, D.C., to guarantee that the profession’s essential care and physician role is fully recognized in emergency laws and regulations, and to secure at least $1 billion in continuity grants and loans for optometry practices nationwide,” according to a post on the group’s website.

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“At an especially confusing time, we’re cutting through the clutter with up-to-the-minute practice guidance and resources and expanded member benefits,” Horn and Reynolds stated. “We are also spotlighting our frontline care and efforts of colleagues across the country to ease the burdens in local emergency departments.”

The plan includes:

  • Approved immediate AOA dues relief. All AOA dues are waived for two months for all members.
  • Approved dues and assessment freeze. AOA membership dues and assessment to be maintained at current levels at least through 2021.
  • Directed program reprioritization. The AOA is dedicating an organization-wide response to the immediate crisis-related concerns of doctors and affiliates, extending all AOA advocacy activities (federal, state, payer and media), communications, AOAExcel, practice tools and more.
  • Approved direct affiliate support. The AOA established a $500,000 fund to assist distressed affiliates.
  • Establishing a long-term relief for doctors. The AOA is working to establish an AOA Foundation Optometry Recovery Fund to aid optometry practices, in partnership with industry friends.

The AOA will be provide additional details about the relief plan in coming weeks.

The organization has launched a COVID-19 updates page where ECPS can locate the latest information from the AOA and U.S. public health authorities.

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