Ophthalmology Times Staff Reports

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-Regeneron Pharmaceuticals Inc. announces that aflibercept (Eylea) has gained FDA approval for treatment of macular edema following central retinal vein occlusion (CRVO). In addition, the drug has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for treatment of neovascular (wet) age-related macular degeneration.

The approval of aflibercept, an inhibitor of vascular endothelial growth factor (VEGF), for macular edema following CRVO was based on data from the phase III COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of best corrected visual acuity at 24 weeks compared with baseline as measured by ETDRS.

Bayer HealthCare and Regeneron are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to aflibercept in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales, except for Japan where Regeneron will receive a royalty on net sales.

Articles

Aflibercept (Eylea, Regeneron) has gained FDA approval for treatment of macular edema following CRVO and recommendation for approval by the CHMP for treatment of neovascular AMD.

Aflibercept gains new approval, recommendation

-Amakem NV has initiated a phase IIa proof of concept study of its novel rho-kinase (ROCK) inhibitor, AMA0076, in patients with glaucoma and ocular hypertension.

The company, a kinase platform company focusing on ophthalmology, recently received Investigational New Drug Application (IND) approval from the FDA.

AMA0076 is a highly potent ROCK inhibitor and is based on Amakem’s “Localized Drug Action” platform, which generates novel kinase inhibitors that minimize the risk of systemic as well as local side effects, such as hyperemia.

The first patients have been enrolled in the multicenter, randomized, double-masked, placebo-controlled dose-escalation study, which will be conducted at six centers in the United States.

AMA0076 is applied topically, as eye drops, and the primary efficacy endpoint will be reduction in IOP after 2 and 4 weeks of dosing.

AMA0076 is aimed at providing better patient outcomes than other ROCK inhibitor-based treatments currently in development because its improved side effect profile enables higher dosing, leading to better efficacy, according to the company.

A phase IIa proof of concept study of a novel rho-kinase (ROCK) inhibitor (AMA0076, Amakem NV) is now underway in patients with glaucoma and ocular hypertension.

Rho-kinase inhibitor in phase IIa study

-Valeant Pharmaceuticals International Inc. has acquired verteporfin for injection (Visudyne) from QLT Inc. Verteporfin is used to treat abnormal growth of leaky blood vessels in the eye caused by wet age-related macular degeneration (AMD).

Valeant paid $62.5 million upfront for all U.S. rights and available inventories for verteporfin and another $50 million upfront for rights to non-U.S. royalties on verteporfin sales. QLT is eligible to receive up to $5 million in contingent payments relating to the development of its laser program in the United States, up to $15 million in contingent payments relating to the Novartis non-U.S. royalties and a royalty on net sales of new indications for verteporfin, if any should be approved.

“We are excited about the opportunity to add a complementary product to our growing ophthalmology business,” said J. Michael Pearson, chairman and chief executive officer, Valeant. “We are pleased to add a product that retinal specialists around the county can use as an adjunctive to products like [pegaptanib for injection] to improve treatment options.”

Jason M. Aryeh, chairman of QLT, said, “On behalf of QLT, we are confident that Valeant is the right company to continue offering [verteporfin] in the [United States] as an important treatment option to patients.”

QLT Inc. announces that it has completed sale of verteporfin for injection (Visudyne) to Valeant Pharmaceuticals International Inc.

Valeant acquires AMD treatment

The University of California San Francisco is putting its vision care and research facilities under one roof with the debut of the UCSF Wayne and Gladys Valley Center for Vision.

UCSF on Monday opened the facility, which is located in San Francisco, across from the UCSF Medical Center at Mission Bay to the west and the Chase Center to the north. The new Valley Center for Vision is home to eye doctors and surgeons, scientists and laboratory facilities.

In a statement, UCSF said the facility will serve the community through an estimated 160,000 patient visits each year.

“The new center is designed to support all of the pillars of our mission: research, teaching, clinical care and service with state-of-the-art facilities,” said Stephen McLeod, MD, Theresa M. and Wayne M. Caygill, MD, Distinguished Professor and chair of ophthalmology at UCSF, in a statement. “It will bring together scientists across multiple disciplines whose work converges on vision and eye health, along with clinician-scientists who are committed to leading-edge patient care.”

According to the statement, the new facility features more than 40,000 square feet of clinic space, 70 patient visit rooms and the up-to-date diagnostic and therapeutic tools.

In addition to routine vision care, the ophthalmology and optometry clinic will provide comprehensive vision exams for adults, as well as specialty care for complex eye conditions, including cataracts, ocular cancer, glaucoma, diabetic eye disease, ocular inflammation, macular degeneration and eye injuries. It will offer both cataract and lens surgeries, as well as laser eye surgery in its LASIK and cosmetic surgery procedure center, according to the release.

The Valley Center for Vision also includes the Francis I. Proctor Foundation, which is dedicated to research and training in infectious and inflammatory ocular diseases, and works to eradicate blindness worldwide, especially in low-income countries.

The adjacent 12-story tower will include administrative and conference space for UCSF faculty and staff from multiple sites, including Parnassus, Mission Center, Mission Bay, Laurel Heights and other leased spaces.

According to the release, center houses a majority of UCSF’s vision-related work under one roof on the same campus as its basic scientists.

The hope is that this will foster the cross-fertilization necessary to advance research and care, and will connect the department’s researchers to Mission Bay’s larger biotechnology and neuroscience hubs, McLeod said in the statement. The center also will enhance the university’s ability to recruit and train the next generation of leaders in the field.

“What most excites us is the opportunity to bring so much talent within the UCSF community and so many resources together to address the most challenging issues of eye health and visual disability,” McLeod said. “We believe that this really will allow UCSF to lead the way in the discovery of exciting new therapies.”

The new facility was made possible by fundraising by the nonprofit foundation That Man May See, which was established almost 50 years ago to support the goal of UCSF ophthalmology, to save and restore sight for present and future generations. UCSF expresses its deepest gratitude to lead funder, the Wayne and Gladys Valley Foundation, and to Theresa M. Caygill, and the Koret Foundation, for the generous support that launched the effort to build a new home for UCSF ophthalmology.

“We are tremendously thankful for the major outpouring of generosity from our donors, grateful patients and the University, who are all helping us reach this milestone to fund our beautiful new home,” said That Man May See chair John F. de Benedetti, who has been blind since the age of 11 and has received care at UCSF for many years. “The new building is a tangible example of That Man May See’s passion and commitment to our cause.”

The University of California San Francisco this week debuted the UCSF Wayne and Gladys Valley Center for Vision, bringing its vision care and research facilities under one roof.

UCSF debuts new home for ophthalmology programs


The American Medical Association (AMA) this week voiced its support for provisions in proposed Continuing Resolution legislation in Congress that would offer relief to financially strapped physician practices.

According to a statement from the office of House Speaker Nancy Pelosi, the House of Representatives is expected to vote this week on a continuing resolution to keep the government funded through Dec. 11.

“The Continuing Resolution introduced today will avert a catastrophic shutdown in the middle of the ongoing pandemic, wildfires and hurricanes, and keep government open until Dec. 11, when we plan to have bipartisan legislation to fund the government for this fiscal year,” Pelosi said in a statement.

The Continuing Resolution includes provisions that would benefit physician practices feeling the financial pinch amid the pandemic.

According to a statement from the AMA, revisions to the Medicare Accelerated and Advance Payments program (AAP) included in the resolution will help keep doors open during the pandemic and continue to offer patients access at this time.

“Upon passage of the Continuing Resolution, patients should know that their physician is more likely to weather the pandemic’s economic challenges,” AMA President Susan A. Bailey, MD, said in a statement. “Congress recognized the danger, and rightfully modified the program so physicians can keep seeing patients.”

According to the release, Centers for Medicare & Medicaid Services worked quickly in the spring to provide financial assistance to physicians, which proved to be a lifeline for many practices.

The AMA also noted in its release that it also appreciated that the CARES Act postponed the start of recoupment for the AAP until 120 days after initial payment and allows up to 210 days for repayment for physicians.

There have been some concerns from physicians regarding their ability to repay the money during the economic conditions amid the pandemic.

The AMA release noted that earlier this year, surveys showed that from March to May revenues in physician offices were down at least 50 percent. As practices began reopening, some physicians were able to recoup some of the loss but not all due to reduced visits and procedures.

Moreover, the AMA noted in its release that the repayment terms are difficult to achieve. According to those terms, physicians would have all of their Medicare claims withheld to repay the loans on a short timeline. After a few months, any outstanding balances a physician might have would be subjected to a 10.25 percent interest rate.

According to the release, the Continuing Resolution would postpone the recoupment of disbursed funds until 1 year after the advance payment has been issued to a physician practice. The balance would be due by September 2022.

The resolution also would reduce the per claim recoupment amount from 100 percent to 25 percent for the first 11 months and the 50 percent of claims withheld for an additional six months. If not repaid in full, the interest rate kicks in. That interest rate also would be lowered from 10.25 percent to 4 percent.

“Members of Congress and the Administration have settled on a bipartisan response to the economic sword hanging over physician practices. This relief will be felt across the county as physicians will be able to continue providing health care during the pandemic,” Bailey concluded in the statement.

If approved in the House, the proposal would then go to the Senate for a vote. 

The American Medical Association is expressing its support for provisions in proposed Continuing Resolution legislation in Congress that could offer relief to financially strapped physician practices. 

AMA supports House plan to ease Medicare loan repayment terms

, eculizumab (Soliris, Alexion) has been approved by the U.S. Food and Drug Administration to treat neuromyelitis optica spectrum disorder (NMOSD). It is an intravitreal injection for adults who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is a rare, central nervous system disease which manifests itself in the optic nerves and spinal cord.

“Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients’ lives,” said Billy Dunn, MD, in a press release. Dr. Dunn is the director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
	
	NMOSD causes an autoimmune reaction in which the body attacks optic and spinal cord cells. In cases of the eye, it can cause optic neuritis, a condition that often leads vision pain and loss. According to the release, nearly 50% of patients affected with NMOSD have permanent paralysis and visual loss. 

A clinical study detailing the effectiveness of eculizumab for the treatment of NMOSD was conducted with 143 patients. The patients all had NMOSD with antibodies against AQP4 (anti-AQP4 positive). Patients were randomized into placebo and eculizumab treatment groups. The results showed patients who received eculizumab treatment had a 94% reduction in NMOSD relapse over the trial period, which was 48 weeks.

Intravitreal injection treats rare autoimmune disease of the central nervous system