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NEWS

Glaukos Receives FDA Approval for Epioxa

Shots:Glaukos reported the US FDA approval of Epioxa HD/Epioxa, an incision-free, topical drug therapy for keratoconus, offering a non-surgical alternative to traditional corneal cross-linkingThe approval was based on two P-III pivotal studies (>400 pts) that met its pre-specified 1EPs strong efficacy and safety; Epioxa uses a UV-activated, oxygen-enriched formulation that preserves the corneal…
October 22, 2025

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NEWS

AviadoBio Enters Exclusive Option & License Agreement with UgeneX Therapeutics to Advance UGX-202

Shots:AviadoBio has entered into an exclusive option & license agreement with UgeneX Therapeutics to develop & commercialize UGX-202As per the deal, AviadoBio will receive an option to develop & commercialize UGX-202 for retinitis pigmentosa & other indications globally (excl. Greater China), while UgeneX will receive upfront payments, r&d milestones, & sales milestone payments…
October 9, 2025

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NEWS

Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region

Shots:Hikma Pharmaceuticals & Celltrion have entered into exclusive licensing agreements for various biosimilar candidates across the Middle East & North Africa (MENA) region, expanding their previous partnershipsThe agreement will include the commercialization of 6 biosimilars to expand access across multiple therapeutic areas, incl. allergic diseases, ophthalmology, skeletal-related disorders, immune diseases & oncologyAs…
October 8, 2025

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Genentech
NEWS

Genentech Presents Long-Term Efficacy and Safety Data on Vabysmo for Wet Age-Related Macular Degeneration

Shots:Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapySALWEEN study in Asia…
September 5, 2025

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INSIGHTS+

Key Biosimilars Events of August 2025  

Shots:       Biosimilars are developed to be highly similar of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…
September 2, 2025

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NEWS

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Shots:Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucomaThe IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpointCalibreye System allows ophthalmologists to control…
August 13, 2025

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INSIGHTS+

Key Biosimilars Events of July 2025  

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the…
August 5, 2025

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Viewpoints_Uwe Gudat
VIEWPOINTS

Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

Shots:At the American Academy of Ophthalmology (AAO 2024), Biocon Biologics announced promising results from the extension study of its proposed biosimilar to aflibercept, MYL-1701PThe study demonstrated comparable safety, efficacy, and immunogenicity between patients continuing MYL-1701P and those who switched from aflibercept to MYL-1701PBiocon Biologics' Chief Medical Officer, Uwe Gudat, discusses the groundbreaking…
March 17, 2025

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ThoughtSpot_Andrea Lacey
THOUGHTSPOT

The Role of Artificial Intelligence in Revolutionizing Eye Surgery

Artificial intelligence (AI) is rapidly transforming ophthalmology, bringing unprecedented precision and safety to eye surgeries. The integration of AI-driven technologies into procedures like LASIK and cataract surgery is revolutionizing patient outcomes, reducing complications, and setting new standards in vision correction. Advancements in machine learning and surgical robotics enable ophthalmologists to perform complex operations with enhanced…
December 13, 2024

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VIEWPOINTS_Sujay Jadhav_2023
VIEWPOINTS

Sujay Jadhav converses about VeraSite, a recently launched subscription-based tool for clinical trial site selection

Shots: In an insightful interview with PharmaShots, Sujay Jadhav, CEO of Verana Health, discusses VeraSite, a recently launched subscription-based tool for clinical trial site selection  To gather real-world data, Verana Health leverages the VeraQ population health data engine and transforms the structured and unstructured data into curated disease-specific modules called QData  Currently available in the…
October 17, 2023

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