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.

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.

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.”

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.