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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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