Tuesday, November 8, 2016

Aerie Pharmaceuticals (AERI) Eyeing Innovative Glaucoma and Ocular Hypertension Therapies

Aerie Pharmaceuticals. Inc. (NASDAQ: AERI) is a publicly traded clinical stage pharmaceutical company focusing on the discovery of innovative treatments for glaucoma and other eye ailments. Its leading product candidates, Rhopressa™ and Roclatan™, are believed to be effective for most glaucoma patients, based on clinical trials results, and are currently in different stages of development in view of commercialization.

It is estimated that glaucoma patients make up the largest segment of the worldwide ophthalmic market, with glaucoma products and therapies exceeding $4.7 billion in global sales. According to National Eye Institute statistics, there are more than 2.7 million glaucoma patients in the United States at the moment. That number is expected to rise to 4.3 million by 2030.

Aerie Pharmaceuticals’ products are both designed to target glaucoma and lower intraocular pressure specifically. Developed in the form of eye drops administered once a day, both treatments have had very good results and tolerance rates during clinical trials, being designed as the first innovative ocular hypertension lowering mechanisms in more than 20 years.

The company completed its second phase 3 registration trial for lead product candidate Rhopressa™ in September 2015 and is now scheduled to file an NDA for the treatment in January 2017. The NDA filing was initially set for the third quarter of 2016, but it was pushed back to January because of an issue related to the third-party manufacturing site, according to a company press release (http://dtn.fm/6ng3R). Although not necessary for the filing, two more phase 3 clinical trials are being conducted for Rhopressa™ (netarsudil ophthalmic solution), this time focusing on the treatment’s safety. All trials so far indicated that the therapy has a consistent IOP lowering effect for the duration of treatment. Aerie also plans to further explore the positive attributes of Rhopressa™, as test results so far indicated a potential synergistic effect with prostaglandin analogues and possibly neuroprotective features.

Roclatan™ (netalsudil/latanoprost) is currently undergoing phase 3 registration trials, which commenced in September last year. The therapy is a fixed dose combination of Rhopressa™ and latanoprost, an approved glaucoma IOP treatment, and all clinical trials so far have indicated its superior efficacy over its components when taken independently. A second phase 3 trial began in March 20016, while a third one, aimed for European approval, is scheduled for the first half of 2016. If the current phase 3 trials are successful, Aerie intends on filing an NDA for this product in the second half of 2017. Based on the results reported so far, Roclatan™ has the potential of being the most efficient glaucoma and ocular hypertension treatment on the market up to this point.

In addition to these two primary product candidates, the company is also exploring Rhopressa’s possible long-term impact on diseases trabecular meshwork and conducting pre-clinical trials for AR-13154, a small molecule with demonstrated effects in reducing the size of lesions associated with age-related macular degeneration.

Financially, the company last week released its revenue report for the third quarter of 2016, which was described as ‘uneventful’ by an Aegis Capital Corp. analysis (http://dtn.fm/9j0Ow). Aerie ended Q3 with more than $255 million in cash and investments and slightly higher operating expenses, but still within the company’s expected range of $75-$85 million for 2016. The Aegis analysis reiterates a ‘Buy’ rating for the company, and a pricing target of $63, compared to the current $33.60 (on November 3 when the report was released). The report also underlines that the company’s financial performance has little impact on share prices, but rather clinical development success and regulatory approvals are more important.

For more information, visit the company’s website at www.aeriepharma.com

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