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Physicians demonstrated limited understanding of the FDA approval process and the meaning of the “breakthrough therapy” designation, according to recent research in JAMA.“Although the term ‘breakthrough’ leads consumers to overly optimistic beliefs about drug effectiveness, it is not known how physicians understand this term — or more generally, what FDA approval means,” Aaron S. Kesselheim, MD, JD, MPH, of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, and colleagues wrote. “A national survey of board-certified internists and specialists revealed substantial deficits in knowledge of the meaning of FDA approval.”

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WALTHAM, Mass.–(BUSINESS WIRE)–Avedro receives FDA approval for its corneal cross-linking product. The product is a first-in-class therapeutic treatment for progressive keratoconus, which is a sight threatening indication.

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Twice-daily 50 µg to 500 µg ocular doses of trabodenoson were well-tolerated, according to a study, and at 500 µg, a dose-related decrease in IOP was seen in patients with primary open-angle glaucoma or ocular hypertension.The multicenter, randomized, double-masked, placebo-controlled, dose-escalation phase 2 study included 141 patients who were administered 50 µg, 100 µg or 200 µg unilateral topical twice-daily trabodenoson (Inotek Pharmaceuticals) or placebo for 14 days, or 500 µg trabodenoson or placebo for 28 days.

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Ohr Pharmaceutical has enrolled the first patient in the first of two phase 3 clinical trials of squalamine lactate ophthalmic solution 0.2% for the treatment of neovascular age-related macular degeneration, according to a press release. The phase 3 cl…

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BASSANO DEL GRAPPA, Italy — At the Bassano Ophthalmology Meeting, OSN Europe Editorial Board Member Stefano Gandolfi, MD, relates one of the commendable “pros” of the meeting: a cross-generational discussion on technological advancements in the management of complications in glaucoma surgery, which included skills and insights of senior ophthalmologists and of new-generation surgeons.

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