Number of FDA new molecular entity approvals in 2020 similar to 2019

Created on:2020-12-18 09:10


The following is a summary of original


A high proportion of the molecular entity approvals had orphan drug and priority review designations, including Horizon Therapeutics’ Tepezza (teprotumumab-trbw), which had an orphan drug designation.

Of 178 new drugs approved between Oct. 1, 2019, and Dec. 3, 2020, five were for ophthalmology.


Novartis received approval for Beovu (brolucizumab-dbll) for the treatment of wet age-related macular degeneration on Oct. 8, 2019.


Horizon received approval for Tepezza, the first drug approved for the treatment of thyroid eye disease, on Jan. 21, 2020. Thyroid eye disease is a rare condition in which the muscles and fatty tissues behind the eye become inflamed and lead to proptosis, Healy said.


Allergan received FDA approval for Durysta (bimatoprost implant) on March 4, 2020. It is indicated for the reduction of IOP in patients with open-angle glaucoma.


Recordati Rare Diseases received FDA approval for Cystadrops (cysteamine ophthalmic solution 0.37%) on Aug. 19, 2020. The cystine-depleting agent is indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.


Kala Pharmaceuticals received FDA approval on Oct. 26, 2020, for Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid indicated for short-term treatment of dry eye disease.


The FDA approved two ophthalmic devices in the same time period out of 56 total device approvals.


CooperVision received approval for MiSight 1-day soft contact lenses on Nov. 15, 2019. The lenses were approved for daily wear and are intended to slow progression of myopia in patients aged 8 to 12 years old. The lenses are also intended for correction of nearsightedness, Healy said.


Alcon received FDA approval for the AcrySof IQ Vivity IOL on Feb. 26, 2020.


“The key upgrade here for Vivity is the visual disturbance profile. The studies have seen the same or even less incidence of visual disturbances, which is a major upgrade in my opinion. When we look at the study data, we see little to no starbursts, halos or glares,” Healy said at the meeting.


Additionally, 64 ophthalmic 510(k) clearances were received between Oct. 1, 2019, and Dec. 3, 2020.




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