Treatment of age-related macular degeneration

The age-relat­ed mac­u­lar degen­er­a­tion (AMD) mar­ket has been dom­i­nat­ed by big phar­ma com­pa­nies and their pipeline can­di­dates are ensur­ing a share of this lucra­tive mar­ket, in spite of patent expiries of their high­ly-priced prod­ucts, accord­ing to GlobalData.

Roche and Novar­tis’ Lucen­tis (ranibizum­ab) was the first anti-VEGF mon­o­clon­al anti­body designed specif­i­cal­ly for the treat­ment of the wet form of AMD. Cur­rent­ly these com­pa­nies spon­sor the high­est num­ber of clin­i­cal tri­als to reclaim their top posi­tion in the AMD space.

“In recent years Regen­eron and Bay­er became top sell­ers in the AMD space with their anti-VEGF, Eylea. How­ev­er, Novar­tis is plan­ning to launch its new anti-VEGF, brolu­cizum­ab in 2019, while Roche will com­pen­sate for its loss through the launch of faricimab, first-in-class bis­pe­cif­ic anti­body in 2024 designed for the treat­ment of wet AMD.”

Dr. Edit Kovalc­sik, Man­ag­ing Phar­ma Ana­lyst at GlobalData

While both Bay­er and Regen­eron are among the top sev­en indus­try spon­sors of clin­i­cal tri­als in AMD, nei­ther of these com­pa­nies have an AMD drug in late stages of devel­op­ment (Phase IIb/ Phase III) and Glob­al­Da­ta expects that they will not launch a new prod­uct by 2026.

The cur­rent AMD mar­ket is rather sparse, com­pris­ing of only five avail­able drugs in the US, 5EU, and Japan and four in Chi­na. One of the mar­ket­ed anti-VEG­Fs, Roche’s Avastin (beva­cizum­ab), is used off-label for wet AMD, main­ly due to its vast­ly low­er price-tag.

Kovalc­sik con­tin­ues: “All three anti-VEGF ther­a­pies are high­ly effec­tive to pre­vent cen­tral vision loss; how­ev­er, major draw-backs include need­ing fre­quent intrav­it­re­al (IVT) injec­tions, which results in poor com­pli­ance and risk of vision loss. Anoth­er prob­lem is the price, which health­care providers have been try­ing to min­i­mize through the off-label use of Avastin, which is a can­cer treatment.”

Accord­ing to GlobalData’s report: ‘Age-Relat­ed Mac­u­lar Degen­er­a­tion: Com­pet­i­tive Land­scape to 2026’ the AMD pipeline con­sists of 236 drugs span­ning all stages of devel­op­ment. Drugs inhibit­ing angio­gen­e­sis remain the major focus of drug devel­op­ers for wet AMD as they account for close to 40% of the pipeline.

Kovalc­sik explains: “Com­pa­nies devel­op­ing new anti-VEG­Fs are try­ing to address the bur­den of fre­quent IVT injec­tions on the patient and the physi­cian, as well as on the hos­pi­tal resources. Novar­tis’ brolu­cizum­ab will poten­tial­ly reduce the dos­ing fre­quen­cy for many more patients than cur­rent­ly avail­able anti-VEGF therapies.”

The oth­er form of the late stage of AMD is a dry or athrop­ic form, called geo­graph­ic atro­phy (GA), for which no effec­tive treat­ments are avail­able, and there­fore these patients remain underserved.

Kovalc­sik con­cludes: “The AMD pipeline is strong although the attri­tion rate is high, par­tic­u­lar­ly in dry AMD, for which all drugs have failed at the clin­i­cal stage of development.

“Out of the eleven drugs in late-stage clin­i­cal devel­op­ment, only two are being devel­oped for the treat­ment of GA: Apel­lis’ APL‑2, and Ophthotech’s Zimu­ra. The major­i­ty, about 70% of the drugs in clin­i­cal stages of devel­op­ment, are designed to treat wet AMD, which leaves plen­ty of oppor­tu­ni­ties for devel­op­ers to come up with effec­tive treat­ments against GA.”