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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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