Pharmaceutical companies shut down development of once-promising candidates.
The San Diego compounder said it will fully comply with regulators, and it expects no impact to its ophthalmic business.
Agency says copies are those that share the same active ingredient, route of administration, dosage form, dosage strength, and excipients.
The company’s path forward may include another clinical trial or submitting current data in its NDA.
The company’s piezo-print technology delivers topical micro-doses of drugs to the eye.
The New York-based company raised a total of $22 million in two recent public offerings.
Company’s clinical investigators predict that this type of IOL will change the way premium cataract surgery is performed.
J&J Vision’s success with its Symfony lens has spurred other companies to enter the segment.
Developer Spark Therapeutics announced a price of $850 thousand per patient.
The probe provides 1.7 million pulses per minute and has a continually open port.
Wuxi Vision Pro gained its first IOL approval from the China FDA.
Glaukos projected sales growth of 35 to 40 percent for its iStent.
Bausch + Lomb’s Vyzulta and Aerie’s Rhopressa are the first to achieve the milestone since 1996.
US surgeons can offer patients corneal inlays, SMILE, topo-guided LASIK, and cross-linking.
Double-digit expansion is expected in this segment over the next five years.
An aging population and greater access to health care will spur a 4 percent per year increase in eye surgeries.
About 300 hospitals are on board so far, and the Department of Veterans Affairs is interested in participating.
The company said it would work closely with the FDA to determine its next steps.
Corneal inlay maker said its immediate focus is on gaining US approval of its Flexivue Microlens.
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