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FDA raises concerns about manufacturing deficiencies in Dextenza complete response letter

July 25, 2016

Ocular Therapeutix received a complete response letter from the FDA regarding the new drug application for Dextenza for the treatment of postoperative ocular pain, according to a press release.

The letter addresses the FDA’s concerns about the deficiencies in the manufacturing process and controls that were identified during a pre-NDA approval inspection of the company’s manufacturing facility, but the FDA did not provide details on which manufacturing deficiencies were identified.

Inotek receives US patent for trabodenoson, prostaglandin analogue for reduction of IOP

July 25, 2016
The United States Patent and Trademark Office has issued a composition of matter patent for trabodenoson in combination with a prostaglandin analogue for reducing IOP in…

Publication Exclusive: Pearls for residents, fellows as surgical training gets underway

July 25, 2016
During medical school there is relatively little exposure to ophthalmology, and only about 2% of all residency positions are devoted to our field. Training in…
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VIDEO: High-resolution OCT findings of macular disorders

July 24, 2016
At Retina 2016, Elias Reichel, MD, shares cases of high-resolution OCT findings of macular disorders from his practice.
Meeting News CoverageVideo

VIDEO: Speaker gives update on infectious uveitis

July 23, 2016
At Hawaiian Eye, Thomas A. Albini, MD, gives an update on infectious uveitis.
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Original Article

Safety and Long-term Outcomes of Congenital Ptosis Surgery: A Population-Based Study

Journal of Pediatric Ophthalmology and Strabismus, July/August 2016, Volume 53 Issue 4
To report the long-term outcomes of childhood ptosis surgery in a population-based setting over a 46-year period. In…
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Emerging Options for Day-in and Day-out IOP Control

This activity is supported by an educational grant from Bausch + Lomb.

Unfortunately, even with appropriate use of currently available medications, many people with glaucoma will still…
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Highlights from ASCRS

Highlights from ASCRS

Meeting News Coverage

VIDEO: Small pupils increase complication rates associated with intraoperative miosis during cataract surgery

July 13, 2016
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