BioCentury | Oct 20, 2017
Clinical News

Aerie's Rhopressa wins FDA panel votes

...discontinuation rate due to adverse events -- 19.3% for Rhopressa compared with 1.7% for comparator timolol...
...patients in pooled data from four Phase III trials compared with less than 1% of timolol...
...Rhopressa lowers IOP, but noted that clinical data showed the therapy was less efficacious than timolol...
BioCentury | Oct 13, 2017
Company News

Aerie's Rhopressa wins FDA panel votes

...discontinuation rate due to adverse events -- 19.3% for Rhopressa compared with 1.7% for comparator timolol...
...patients in pooled data from four Phase III trials compared with less than 1% of timolol...
...Rhopressa lowers IOP, but noted that clinical data showed the therapy was less efficacious than timolol...
BioCentury | Oct 11, 2017
Company News

FDA reviewers concur with Aerie on Rhopressa's efficacy

...that among patients with higher maximum baseline IOP (≥25 mmHg), Rhopressa was less efficacious than timolol...
...missed the Phase III Rocket 1 trial's primary endpoint by failing to show non-inferiority to timolol...
...identified safety risks. The committee will also discuss suggestions for draft labeling of the product. Allison Johnson Rhopressa timolol Aerie...
BioCentury | May 15, 2017
Company News

FDA reviewing Aerie's resubmitted NDA

...primary endpoint of the Phase III Rocket 2 study, improving intraocular pressure (IOP) compared to timolol...
...missed the primary endpoint of the Phase III Rocket 1 study, but was non-inferior to timolol...
BioCentury | Jan 6, 2017
Clinical News

Trabodenoson: Ph III MATrX-1 data

...day 84 by 4.25 mmHg vs. 2.38 mmHg for placebo and 5.29 mmHg for 0.5% timolol...
BioCentury | Nov 11, 2016
Clinical News

Rhopressa: Ph III Rocket 4 data

...hypertension showed that once-daily 0.02% Rhopressa eye drops met the primary endpoint of non-inferiority to timolol...
...of >20 mmHg and <25 mmHg. Rhopressa also met the secondary endpoint of non-inferiority to timolol...
...with a baseline IOP of >20 mmHg and <27 mmHg. Additionally, Rhopressa was non-inferior to timolol...
BioCentury | Oct 27, 2016
Company News

Aerie withdraws Rhopressa NDA on manufacturing delay

...the primary endpoint of the Phase III Rocket 4 study by showing non-inferiority to twice-daily timolol...
BioCentury | Sep 5, 2016
Clinical News

Trabodenoson: Completed Phase III enrollment

...the double-blind, U.S. Phase III MATrX-1 trial comparing topical trabodenoson vs. twice-daily placebo or 0.5% timolol...
BioCentury | May 23, 2016
Strategy

Two heads are better

...and surgical devices as well as its ophthalmic drugs. The drugs included fixed-dose combinations Azarga brinzolamide/timolol...
BioCentury | Apr 25, 2016
Politics, Policy & Law

SCOTUS to the rescue?

...[2] Diprivan propofol from Fresenius Kabi [1] Gattex teduglutide from Shire [2] Combigan brimonidine / timolol...
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