The recent FDA approval of Novartis AG’s NVS Beovu (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD) has put the spotlight on this promising space.
What is Wet AMD?
Wet AMD is a chronic, degenerative eye disease caused by an excess of a protein called vascular endothelial growth factor (VEGF). The protein triggers growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision. The fluid that seeps through these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula. It is the main cause of blindness, which per estimates affects more than 20 million people.
Approved Treatments for Wet AMD
Regeneron Pharmaceuticals’ REGN and Bayer’s BAYRY blockbuster drug Eylea (aflibercept) is one of the market leading treatments for wet AMD. Eylea is a VEGF inhibitor indicated for the treatment of patients with wet AMD along with other retinal conditions. The drug holds a dominant position in this area.
Roche’s RHHBY Lucentis (ranibizumab) is another leading drug to address wet AMD. Novartis has a collaboration with Roche for Lucentis. The latter has another drug by the name Avastin (bevacizumab) for the treatment of wet AMD (off-label).
Hence, the approval of Beovu will induce stiff competition for both Eylea and Lucentis. Beovu is the first FDA approved anti-VEGF to offer greater fluid resolution compared to Eylea. The former also has the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy. Frequent injections are a common reason why patients discontinue with the treatment. Therefore, Beovu’s potential to treat patients with quarterly injections is a major positive and should enable it to capture a decent market share.
Promising Candidates in Pipeline
Meanwhile, given the global market prospects, there are many candidates in development for wet AMD.
Let us take a look at some of the promising ones:
Allergan’s AGN anti-VEGF treatment abicipar pegol is one of the most promising candidates being developed for the treatment of wet AMD. The company has partnered with clinical-stage biotechnology company Molecular Partners for the development of abicipar pegol. The FDA has accepted a Biologics License Application (BLA) for abicipar pegol and is expected to deliver its verdict in mid-2020. The European Medicines Agency (EMA) too has validated a Marketing Authorisation Application (MAA) for abicipar pegol and a decision from the European Commission is awaited in the second half of 2020.
Meanwhile, Roche is developing a port delivery system implant for ranibizumab. The company is also developing a bispecific antibody faricimab (RG7716) that targets both VEGF and Ang2 for wet AMD (currently in phase III studies).
Privately held Graybug Vision, Inc. is a clinical stage pharmaceutical company developing long-acting therapies for ocular diseases including wet AMD. The company is developing GB-102, a microparticle depot formulation of the small molecule tyrosine kinase inhibitor sunitinib. The candidate is a pan-VEGF receptor inhibitor, currently under evaluation as a twice-per-year therapy using a simple intravitreal injection for wet AMD.
The company recently initiated a phase IIb study called ALTISSIMO. It is a 12-month, 3-arm, randomized controlled analysis to evaluate two dose levels of GB-102 (1 mg and 2 mg) administered every six months compared to Eylea (2 mg), which is administered every two months to patients with wet AMD.
Meanwhile, the clinical-stage biotechnology company REGENXBIO Inc. RGNX is developing a gene therapy RGX-314 for the treatment of wet AMD. The entity completed dosing in the phase I/IIa study for RGX-314 to treat wet AMD and further intends to initiate a phase IIb program in late 2019.
Of all the above-mentioned stocks, Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Given the substantial market opportunity, quite a few pharma/biotech companies are scampering in to develop effective treatments for wet AMD that can manage less frequent dosing. Hence, we expect a flurry of activity in this space in the near future.
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