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After announcing topline data from two identical Phase III trials, Roches Genentechhas doubled down on dataand is now showing positive results from four studiesfor itsnewestblindness-fighting treatment.

Faricimabis an injectable treatment to maintain the vision of patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). These are two of the leading causes of blindness withnAMDresponsible for 90% of all blindness resulting from AMD.

Genetechs Lucentis was thefirst FDA-approved drugprovento restore sight innAMDpatients.Since 2006 it had been a game-changer in theophthalmologyworld. But thenRegenerons Eyleacame in as the main contender andthe companies have had to share the market since 2011.

Genentech is now stepping it upwithfaricimab,a new class of medicine. Instead of focusing onthesingle protein targetVEGF, like Lucentis and Eylea,faricimabis a bispecific antibody.The drug targets two distinct pathways -via angiopoietin-2 (Ang-2) and VEGF-A.This approach bothreduces the growth of blood vessels on the retinalike its predecessorsandstabilizesvessels to reduce inflammation in the eye.

Thetreatmentalso gets a major leg up from proof of ability to go longer between injections.

Patients are understandably put off by an injection to the eyeball. Couple that with fears over COVID-19 exposure and sales of current Lucentis treatments seriously dipped in 2020 by 16%, about $1.6 billion.

Lucentisinjections wereneededmonthly for most patients.Competitor Eylea was needed monthly or bi-monthly, depending on the patient.The burden of treatment has proven to lead to under-treatment and therefore less than optimal outcomes for patients vision.

Faricimabspotential to extend time between treatments may benefit those patients who struggle to keep up with the regular physician visits and eye injections needed to preserve their vision,said Jeffrey Heier, M.D., Director of Retinal Research at Ophthalmic Consultants of Boston in Boston, Mass.

Genentechs clinical trial design was the proofin the pudding forthis new drug. The four studies consistently showedfaricimabto bejust aseffectiveas competitor Eylea even when administered at longer intervals. Half of the patients were able to be treated effectively once every four months. About75% were eligible for treatment every three monthsor longer.Both are a major improvement to patient convenience compared to monthly or even bi-monthly injections.

These positive results show the potential forfaricimabas the first new type of medicine in 15 years for people with neovascular age-related macular degeneration and in close to a decade in diabetic macular edema, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. This is an exciting time for our ophthalmology clinical development program, with multiple Phase III successes for two medicines from our late-stage pipeline. We hope to bring these potential treatments to people living with vision-threatening retinal conditions as soon as possible.

Genentech has not yet announced when they will seek FDA approval forfaricimabbut experts anticipate an aggressive timeline.

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This entry was posted on February 14, 2021 at 7:23 pm and is filed under Blindness. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |