Stock flies high on Clear­side’s PhI­II mac­u­lar ede­ma tri­al re­sults as drug im­proves vi­sion

The stock is soar­ing at Clear­side Bio­med­ical $CLSD, a Geor­gia-based bio­phar­ma de­vel­op­ing eye drugs that tack­le blind­ness, fol­low­ing news that one of its treat­ment im­proved vi­sion in pa­tients.

The re­sults are from a Phase III tri­al test­ing the treat­ment against mac­u­lar ede­ma as­so­ci­at­ed with in­flam­ma­tion of a part of the eye known as uveitis. Mac­u­lar ede­ma is the buildup of flu­id in the part of the eye known as mac­u­la, re­sult­ing in dis­tort­ed vi­sion.

Rahul Khu­rana

“Typ­i­cal­ly, uveitic mac­u­lar ede­ma may per­sist de­spite ad­e­quate con­trol of uveitis it­self, and it is chal­leng­ing to treat and may per­sist de­spite mul­ti­ple in­ter­ven­tions,” said Rahul Khu­rana, an in­ves­ti­ga­tor, in a state­ment.

Clear­side’s prod­uct is called supra­choroidal CLS-TA, which is cor­ti­cos­teroid tri­am­ci­nolone ace­tonide for­mu­lat­ed for ad­min­is­tra­tion to the back of the eye.

The com­pa­ny said 47 per­cent of pa­tients be­ing ad­min­is­tered its treat­ment could see at least 15 let­ters, com­pared to 16 per­cent for pa­tients who un­der­went a place­bo pro­ce­dure.

The ran­dom­ized, con­trolled, and masked tri­al in­volv­ing 160 pa­tients met both its pri­ma­ry and sec­ondary end­points.

“While cor­ti­cos­teroids are the most com­mon treat­ment for all com­pli­ca­tions of uveitis, in­clud­ing the as­so­ci­at­ed mac­u­lar ede­ma, sys­tem­at­ic con­trolled stud­ies of this kind are rare,” Khu­rana said. “I be­lieve that based on these pos­i­tive re­sults, and if mar­ket­ing au­tho­riza­tion is ob­tained from the FDA, supra­choroidal CLS-TA has the po­ten­tial to be­come a new par­a­digm for the treat­ment of vi­su­al im­pair­ment as­so­ci­at­ed with mac­u­lar ede­ma as­so­ci­at­ed with non-in­fec­tious uveitis.”

The com­pa­ny plans to sub­mit an NDA for the treat­ment dur­ing the fourth quar­ter of this year. It’s al­so “eval­u­at­ing a num­ber of op­tions” for sub­mis­sions to reg­u­la­to­ry agen­cies out­side the US.

Clear­side’s stock is up 66% in pre-mar­ket trad­ing. As of press time, shares were sell­ing at $13 per share, up from yes­ter­day’s mar­ket close of $7.82.

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.

Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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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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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.