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Roche’s Ophthalmology Drug Fails to Meet Primary Endpoint

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Roche Holding AG RHHBY announced that its ophthalmology candidate, lampalizumab, did not meet the primary endpoint in Spectri, the first of two phase III studies.

Roche is evaluating lampalizumab for the treatment of GA due to age-related macular degeneration (AMD).

Following the news, shares of the company dropped about 1.9%. Roche’s shares have underperformed the industry year to date. The stock has been up 10.4% compared with the industry’s gain of 14.8% in the same time frame.


Notably, the Spectri study showed that lampalizumab did not reduce mean change in geographic atrophy (GA) lesion area compared to sham treatment at one year (48 weeks). Furthermore, dosing for patients will be stopped until the results from the second phase III study — Chroma — are evaluated with results expected in November 2017. However, safety profile was in line with previous lampalizumab studies and other intravitreal therapies.

In fact, both Spectri and Chroma are identically-designed, double-masked, global studies evaluating the efficacy and safety of a 10 mg dose of lampalizumab administered every four or six weeks by intravitreal injection versus sham injections in patients with GA due to AMD.

Markedly, the failure of the study is a setback for Roche’s ophthalmology pipeline portfolio.

Another company, Ophthotech Corporation OPHT is evaluating its pipeline candidate Fovista in a phase III study (OPH1004) in combination with either Regeneron Pharmaceuticals, Inc.’s REGN Eylea or Roche’s Avastin versus Eylea or Avastin monotherapy for treating wet AMD.

However, Ophthotech study failed as the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in the study, per data announced last month.

Two other studies on Fovista — OPH1002 and OPH1003 — evaluating Fovista, in combination with Novartis AG’s NVS Lucentis, for the treatment of wet AMD, had earlier failed to meet the same primary endpoint. The data was announced last year.

Roche Holding AG Price

Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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