Age Related Macular Degeneration

Clover Therapeutics turns a new leaf as Character Bio to pursue dry AMD & more

Dry age-related macular degeneration currently has no FDA-approved treatments but the research of Clover Therapeutics has yielded two candidates. The biotech startup has made progress in the past two years under CEO Cheng Zhang and it’s now revealing more details about its approach, a new corporate identity, and a Series A financing that puts it …

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Kodiak Sciences’ trial failure clouds eye drug’s prospects for challenging Eylea

A Kodiak Sciences drug failed to beat a Regeneron Pharmaceuticals product in a key test in the wet form of age-related macular degeneration. The biotech says the failure is due to a subset of undertreated patients, but the results raise the stakes for the drug, its lead product candidate, in other eye diseases.

Unity Bio slashes headcount in half to save cash ahead of eye drug readouts

Unity Biotechnology’s corporate restructuring is a cash-saving move that allows the company to focus resources on its lead program, a drug in Phase 2 testing for diabetic macular edema and wet age-related macular degeneration. Unity previously restructured in 2020 following the Phase 2 failure of its osteoarthritis drug.

Sanofi eyes a gene therapy prospect and commits $60M for a stake, potential rights

Sanofi is committing up to $60 million to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular vision loss disorder. The deal also gives the pharma giant right of first refusal on that gene therapy in certain geographies.

FDA clears Roche’s Susvimo implant for eye disease wet AMD

Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to regular injections into the eye. Susvimo has the same active ingredient as Roche’s big-selling therapy Lucentis (ranibizumab), a VEGF inhibitor administered once a month that has been approved by the …

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Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain

Win-win for Biogen as its Biosimilar Gets Approval for AMD  Samsung Bioepis and Biogen’s biosimilar drug, Byooviz, received USFDA approval for the treatment of vision loss, Age-related macular degeneration and has become the first biosimilar to Lucentis in the AMD market. The Lucentis copycat had also managed to score regulatory approval in the United Kingdom …

Biogen’s AMD Biosimilar Gets Approval; SmartLabs Series B Funding; BARDA, Partner Therapeutics in Sepsis Space; Synlogic to Explore Sepsis Market Domain Read More »

FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. The US green light for Byooviz (formerly SB11) covers the treatment of wet age-related macular degeneration (AMD) and two …

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FDA starts review of Roche’s eye disease drug, setting up 2022 verdict

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy …

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Bayer’s BlueRock Therapeutics widens cell therapy scope to the eye under new pact

BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies for eye diseases. BlueRock is paying its new partners $30 million up front to kick off the alliance.

Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration

Shots: The P-III YOSEMITE & RHINE studies involve assessing faricimab (6mg at personalized dosing intervals of up to 4mos. and at fixed 2mos. intervals) vs aflibercept (2mg, fixed 2mos. intervals) in 1891 patients with DME The P-III TENAYA & LUCERNE studies assessing faricimab (6mg administered at fixed intervals of every 2,3 & 4mos. based on …

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Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Shots: Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping …

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