Less than a year af­ter Rho­pres­sa launch, Aerie scores new glau­co­ma drug ap­proval

Just over a year af­ter se­cur­ing ap­proval for its glau­co­ma drug, Rho­pres­sa, Aerie Phar­ma­ceu­ti­cals has fol­lowed up with an ap­proval for its sec­ond such treat­ment en­gi­neered to tack­le hard-to-treat cas­es of the com­mon eye dis­ease that if un­treat­ed typ­i­cal­ly cul­mi­nates in blind­ness.

The new ap­proval, grant­ed by the FDA on Tues­day, is for Rock­la­tan — a once dai­ly eye drop com­pris­ing the wide­ly used gener­ic la­tanoprost and ne­tar­sudil, the ac­tive in­gre­di­ent in Rho­pres­sa. 

Glau­co­ma is char­ac­ter­ized by dam­age to the op­tic nerve, usu­al­ly caused by flu­id build­ing up in the front part of the eye, which in­creas­es pres­sure in­side the eye. This leads to the pro­gres­sive de­gen­er­a­tion of reti­nal cells, re­sult­ing in vi­sion loss and even­tu­al­ly blind­ness. Ac­cord­ing to es­ti­mates by the Glau­co­ma Re­search Foun­da­tion, over 3 mil­lion Amer­i­cans have glau­co­ma but on­ly half of those know they have it.

Rho­pres­sa works by restor­ing out­flow through the tra­bec­u­lar mesh­work — the eye’s pri­ma­ry flu­id drain and the dis­eased tis­sue re­spon­si­ble for el­e­vat­ed in­traoc­u­lar pres­sure (IOP) in glau­co­ma — while la­tanoprost in­creas­es flu­id out­flow through a sec­ondary mech­a­nism known as the uveoscle­r­al path­way, Aerie said.

Rock­la­tan’s ap­proval was based on two late-stage stud­ies: MER­CURY 1 and MER­CURY 2, in which the drug demon­strat­ed sta­tis­ti­cal­ly su­pe­ri­or IOP re­duc­tion over la­tanoprost or ne­tar­sudil alone at every mea­sured time point. It is al­so be­ing eval­u­at­ed in the MER­CURY 3 piv­otal study for Eu­ro­pean reg­u­la­tors.

El­e­mer Piros

“Rock­la­tan has the abil­i­ty to ad­dress high­er pres­sures and more-dif­fi­cult-to-ad­dress glau­co­ma cas­es, giv­en the drug con­tains la­tanoprost. La­tanoprost is an added prostaglandin that could be used to in­crease drainage out­flow. From the MER­CURY stud­ies, >60% of pa­tients tak­ing Rock­la­tan achieved IOP re­duc­tions of >30% (2x greater than what was seen by pa­tients tak­ing la­tanoprost alone). By 2021, we ex­pect Rock­la­tan to have the same mar­ket share as Rho­pres­sa, which we be­lieve could be sur­passed start­ing in 2022,” Can­tor Fitzger­ald’s El­e­mer Piros wrote in a note.

In the lead up to the de­ci­sion for Rho­pres­sa, FDA staff had high­light­ed that the drug did not work as well as the com­para­tor ther­a­py (tim­o­lol oph­thalmic so­lu­tion) in the more se­vere­ly af­flict­ed pa­tients (with IOP ≥ 25 mmHg) in­clud­ed in their Phase III stud­ies. Giv­en that Rock­la­tan is de­signed to tap in­to the spec­trum of IOP-low­er­ing mech­a­nisms, it could be suit­ed for pa­tients with such ad­vanced dis­ease. 

Rho­pres­sa was launched last April, and made about $24.2 mil­lion over the course of the year. Rock­la­tan, ex­pect­ed to hit the mar­ket in the sec­ond quar­ter of 2019, is al­ready un­der re­view for re­im­burse­ment by ma­jor play­ers, the com­pa­ny said. 

Difei Yang

“(I)nsurance cov­er­age pick­up could be faster as con­tracts with pay­ers will al­ready be in place (from Rho­pres­sa),” Mizuho an­a­lyst Difei Yang wrote in a note.

In a sep­a­rate re­lease, Aerie man­age­ment pro­ject­ed full-year 2019 rev­enue in the range of $110 mil­lion to $120 mil­lion for Rho­pres­sa and Rock­la­tan com­bined. “We see this guid­ance as con­ser­v­a­tive and we be­lieve there is a rea­son­able chance for Aerie to out­per­form in 2019,” Yang added.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Mar­ket­ingRx roundup: Phar­mas lay off Twit­ter ads for an­oth­er week; WPP un­cov­ers LGBTQ+ mar­ket­ing find­ings

When Twitter’s new owner Elon Musk tweeted this weekend, “Just a note to thank advertisers for returning to Twitter,” he likely wasn’t talking about big pharma companies. The vast majority of the top spending pharma advertisers had not returned last week, according to updated tracking data Pathmatic for Endpoints News.

Only three pharma advertisers spent any money at all, which is about the same as the past several weeks. AstraZeneca rejoined the active advertiser list, although at $700 spent hardly worth a personal Musk expression of gratitude. GSK remained active with $3,500 spent ad much lower than its previous spending, according to the Pathmatics data. Only Bayer spent any significant amount in advertising, with $244,000 spent last week, but that’s a considerable drop from almost $500,000 spent on OTC, prescription and corporate Twitter ads in each of the previous two weeks.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Jay Lichter, Arialys Therapeutics CEO (Avalon Ventures)

Scoop: Aval­on, MPM back new CNS biotech with sci­en­tif­ic chops from Astel­las

A preclinical central nervous system biotech is in the works in La Jolla, CA, and the drug developer has reeled in capital from a syndicate of investors, Endpoints News has learned.

Arialys Therapeutics filed incorporation documents in the Golden State last December and applied its name for trademark protection with the US Patent and Trademark Office the week prior to that. Paperwork with the SEC also outlines plans to offer up equity in exchange for $55 million.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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