CEO Ben Bergo (Visus)

No more squint­ing at menus? Vi­s­us Ther­a­peu­tics nabs $36M for pres­by­opia-cor­rect­ing eye drop

Vi­s­us Ther­a­peu­tics is off to a bit of a late start in the race for a ther­a­peu­tic al­ter­na­tive to read­ing glass­es. But with an added $36 mil­lion in the bank, CEO Ben Bergo is eye­ing a quick Phase II launch for the com­pa­ny’s dou­ble-agent eye drops.

Bergo co-found­ed Vi­s­us back in 2019, af­ter se­cur­ing the patents to the com­pa­ny’s lead can­di­date Brimo­chol from an­tivi­ral pi­o­neer Herb Kauf­man. The mi­otic-based eye drop for pres­by­opia is a com­bi­na­tion of two FDA-ap­proved phar­ma­ceu­ti­cals: car­ba­chol (mar­ket­ed as Mio­stat) and bri­moni­dine tar­trate.

What makes Brimo­chol dif­fer­ent from oth­er sin­gle-agent mi­otics is the ad­di­tion of bri­moni­dine tar­trate, Bergo told End­points News. Mi­otic agents like car­ba­chol con­strict the pupil to in­duce what’s called the “pin­hole ef­fect.” Sim­i­lar to re­duc­ing the aper­ture of a cam­era, shrink­ing the pupil brings near im­ages in­to clear­er fo­cus.

But of­ten­times, pa­tients who take sin­gle-agent mi­otics re­port headache or brow ache, my­opic shift, eye red­ness, or a loss of dis­tance vi­su­al acu­ity, Bergo said. Bri­moni­dine damp­ens those ef­fects.

“Bri­moni­dine in­hibits the con­trac­tion of the cil­iary mus­cle, which means that we don’t end up with this my­opic shift,” the CEO said. “Pa­tients end up with a drug that gives them this meio­sis, this pin­hole ef­fect, with­out the un­want­ed side ef­fects.”

Bergo said the drops promise long-last­ing ef­fects, cit­ing pri­or stud­ies which sug­gest the ef­fect could last at least eight hours.

“We see this hav­ing the po­ten­tial to be an all-day pres­by­opia-cor­rect­ing eye drop,” he said. “Imag­ine you wake up in the morn­ing, you put the drop in — you know 7am or so, 8am — you go to work, and you’re still ob­vi­ous­ly ben­e­fit­ing from this im­prove­ment in your vi­su­al acu­ity all the way through your work­day, through un­til the evening.”

Vi­s­us plans to en­ter Brimo­chol in a short Phase II study with 40 pa­tients this quar­ter, and read out topline da­ta at the end of Q2 2021. If all goes well, the biotech will launch piv­otal stud­ies in Q3 2021. The Se­ries A should take the com­pa­ny all the way through Phase II, and in­to two Phase III tri­als, Bergo said.

Vi­s­us isn’t out to re­place read­ing glass­es al­to­geth­er.

“I think some pa­tients may use an eye­drop such as ours pre­dom­i­nant­ly and re­ly on read­ing glass­es on­ly in a very small sub­set of sit­u­a­tions,” he said. “Oth­er pa­tients may use their read­ing glass­es, say, on the week­end but use an eye­drop­per like ours through their work­week.”

Pres­by­opia is es­ti­mat­ed to af­fect 2.1 bil­lion peo­ple world­wide. But Vi­s­us has some catch­ing up to do if it wants to carve a place in that mar­ket. Ab­b­Vie read out pos­i­tive topline Phase III re­sults in Oc­to­ber for AGN-190584, a pres­by­opia can­di­date it in­her­it­ed in the Al­ler­gan buy­out. Ora­sis launched a Phase III tri­al for its own pres­by­opia can­di­date around that same time. And in a proof-of-con­cept study, 78% of pa­tients giv­en OS­RX Phar­ma­ceu­ti­cals’ Eye Fo­cus main­tained 20/40 vi­sion for 8 hours.

John­son & John­son In­no­va­tion, RTW In­vest­ments, LP and Wille AG par­tic­i­pat­ed in Vi­s­us’ Se­ries A.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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