Pharma

YUTIQ Approval Latest Step in EyePoint’s Transformation

YUTIQ Approval Latest Step in EyePoint’s Transformation

The steroidal implant YUTIQ for treatment of chronic, noninfectious posterior uveitis is the second drug in EyePoint Pharmaceuticals’ ophthalmology portfolio to receive Food and Drug Administration approval this year – a signature accomplishment for an established pharma company let alone one that rebranded itself just seven months ago – but YUTIQ will leapfrog its previously…

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First US-Approved Nerve Growth Factor is for the Eye

First US-Approved Nerve Growth Factor is for the Eye

In the use of biological agents for treatment of eye disease, the back of the eye has been pretty much the sole domain thanks to the broad acceptance of anti-VEGF drugs for treatment of age-related macular degeneration, diabetic macular edema, and retinal vascular disorders, but the Italian biopharmaceutical firm Dompé has received US approval for…

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Novartis’ Guerard Shares Plans for Brolucizumab, Lucentis, Gene Therapy, and FocalView App

Novartis’ Plans for Brolucizumab and Beyond

Coming off the positive feedback at the American Society of Retina Specialists meeting to trial results of the investigative anti-VEGF agent brolucizumab, Frederic Guerard, Novartis’ franchise head of ophthalmology, provides insight into his team’s strategy for bringing brolucizumab to market while keeping its global commitment to Lucentis, for which Novartis holds ex-US licensing rights, as…

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After Trial Results, Allergan Set to Tweak Abcipar Formulation

After Trial Results, Allergan Set to Tweak Abcipar Formulation

Last week, one day before the American Society of Retina Specialists and OIS Retina convened in Vancouver, Allergan and its collaborative partner Molecular Partners touted the release of top-line results from two Phase III clinical trials showing its abcipar pegol DARPin drug met its primary endpoint – noninferiority to ranibizumab (Lucentis, Roche/Genentech) for treatment of…

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Ocular Therapeutix Revamps to Address FDA’s Dextenza Concerns

Ocular Therapeutix Revamps to Address FDA’s Dextenza Concerns

When Ocular Therapeutix resubmitted its new drug application for Dextenza late in June, it represented a milestone in the company’s effort to essentially reshape itself from a device to a pharma firm. And this time, Ocular thinks it has come up with the formula to gain FDA approval. This latest new drug application (NDA) resubmission…

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Anti-VEGF Biosimilars Target a Shifting Market

Anti-VEGF Biosimilars Target a Shifting Market

Developers of FYB201 may be getting a leg up in the race for a Lucentis biosimilar with the publication of interim results that confirm the efficacy of the candidate for monthly treatment of neovascular age-related macular degeneration (nAMD), with plans to bring it to market in 2020. However, a new generation of anti-VEGF agents that…

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How Badly Does Takeda Want Shire’s Ophthalmology Franchise?

How Badly Does Takeda Want Shire's Ophthalmology Franchise

Shire plc’s decision last week to accept the $62 billion acquisition offer by Takeda Pharmaceutical Company Ltd. has fed speculation in the pharma trade press about the future of Shire’s ophthalmic franchise in the combined company. Takeda’s Take Takeda CEO Christophe Weber hardly mentioned ophthalmology in an analyst call after the acquisition agreement was announced.…

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A String of Pearls for Navigating the FDA

A String of Pearls for Navigating the FDA

WASHINGTON, DC – Having OIS@ASCRS 2018 here provided the perfect opportunity for representatives of the US Food and Drug Administration to impart wisdom on how attendees can help streamline application and approval processes for their innovations. The OIS@ASCRS Master Class, held the morning after OIS@ASCRS, featured staff members from the FDA’s Center for Devices and…

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15 Things We Learned at OIS@ASCRS

Takeaways from OIS@ASCRS 2018

Here are 15 takeaways from last week’s OIS@ASCRS 2018. Barry Cheskin of PowerVision reported on a pilot study of 27 patients who had the FluidVision accommodating intraocular lens implanted. The average objective accommodation at six months measured 2.00 diopters, he said. For the first time, Keranova presented preclinical results of its all-in-one cataract surgery platform.…

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41 Things On Tap at OIS@ASCRS

41 Things On Tap at OIS@ASCRS

There are 41 different sessions, panels, and presentations happening at OIS@ASCRS 2018 – including five different breakout sessions on everything from dry eye to emerging glaucoma therapies, the signature sessions on public market activity and “Masters of the Industry,” and a new panel on frontiers in femtosecond lasers. It’s all set for next Thursday, April…

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Will ODs Take Over Ocular Surface Disease Treatment?

Can ODs Take Over Ocular Surface Disease?

Over the past decade, the treatment of ocular surface conditions such as dry eye and meibomian gland dysfunction (MGD) has evolved from “pats on the back” and warm compresses to innovative and effective tools and drugs, including Shire’s Xiidra, Allergan’s TrueTear (and, of course, Restasis), and Johnson & Johnson Vision Care’s (J&J VC) LipiFlow and…

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