Novartis recently filed RTH258 - otherwise known as brolucizumab - with the FDA for the treatment of wet age-related macular degeneration (AMD).

During the company’s first quarter earnings call on Wednesday, CEO Vas Narasimhan cited RTH258 as one of the biggest potential growth drivers in the late stage pipeline. Its approval could allow Novartis - a leading player in the European ophthalmology market (where it holds marketing rights for Lucentis) - to gain a significant foothold in the US market, he said.

Its launch could therefore have significant implications for Regeneron and Roche which market the AMD therapies Eylea and Lucentis, respectively, in the US. To get a better understanding of how RTH258 could potentially be used we are snap-polling US ophthalmologists with the following five questions…

_________

Q. The FDA has accepted for review a regulatory application for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

The regulatory application is primarily based on Phase III data from the HAWK and HARRIER trials. The primary endpoint of these studies was non-inferiority to aflibercept in mean change in best-corrected visual acuity (BCVA) from baseline to week 48 (mean change in BCVA of 6.6 letters for brolucizumab 6 mg versus 6.8 letters for aflibercept in HAWK and 6.9 letters versus 7.6 letters, respectively, in HARRIER). HAWK and HARRIER are the first and only global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy at week 48 starting with a 12-week dosing regimen.

Additionally, at week 48 in the studies, key secondary endpoint assessments showed significantly fewer brolucizumab patients with disease activity (23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and 21.9% versus 31.4%, respectively, in HARRIER) as well as retinal fluid - key markers used by physicians to help guide management of the disease in clinical practice (31% fewer patients on brolucizumab 6 mg had intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) in HAWK, and 26% fewer in HARRIER, versus aflibercept.

Based on these data how would you compare the efficacy profile of brolucizumab versus current standard of care therapy for AMD?

Much worse

Somewhat worse

About the same

Somewhat better

Much better

_________

Q. At year two, the most frequent ocular adverse events (=>5% of patients in any treatment arm) for brolucizumab 3 mg, 6 mg and aflibercept, respectively, in HAWK were conjunctival hemorrhage (10.9%, 8.1% and 8.9%), reduced visual acuity (9.5%, 6.1% and 8.1%), vitreous floaters (7.3%, 6.1% and 4.4%), eye pain (7.8%, 5.0% and 5.8%), retinal hemorrhage (3.9%, 5.8% and 5.6%), cataract (5.0%, 5.6% and 3.6%), vitreous detachment (6.7%, 5.3% and 5.3%) and dry eye (5.6%, 5.3% and 7.2%)[5]. The incidences of these events for brolucizumab 6 mg and aflibercept, respectively, in HARRIER were conjunctival hemorrhage (4.6% and 5.1%), reduced visual acuity (8.6% and 7.0%), vitreous floaters (4.1% and 1.4%), eye pain (3.5% and 5.1%), retinal hemorrhage (3.2% and 1.1%), cataract (3.0% and 11.7%), vitreous detachment (2.7% and 2.2%) and dry eye (2.7% and 3.0%).

Based on these data how would you compare the safety profile of brolucizumab versus current standard of care therapy for AMD?

Much worse

Somewhat worse

About the same

Somewhat better

Much better

_________

Q. Based on these clinical data and using a five point scale (where 1 = not willing to prescribe and 5 = very willing to prescribe) how willing will you be to prescribe brolucizumab during its first 12 months of launch?

_________

Q. Based on these clinical data and using a five point scale (where 1 = not willing to prescribe and 5 = very willing to prescribe) how willing will you be to prescribe brolucizumab during its first 24 months of launch?

_________

Q. What impact will the approval of a modified 12-week dosing schedule for aflibercept last year (August 2018) have on limiting your future adoption of brolucizumab?

Using a five point scale where 1 = no impact and 5 = significant impact.

_________

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls.  However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.

By: Simon King

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